Trial Outcomes & Findings for A Study to Evaluate the Effects of Indacaterol Maleate as a New Formulation in the Concept 1 Device (NCT NCT01484197)
NCT ID: NCT01484197
Last Updated: 2015-04-01
Results Overview
Spirometry was performed according to internationally accepted standards at Day 8. Trough FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. Trough FEV1 was defined as the average of the FEV1 measurements at 23 hours 10 minutes and 23 hours 45 minutes post dose.at Day 8. Analysis of Covariance with treatment, period, sequence and subject nested within sequence as fixed effects and period FEV1 baseline as a covariate.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
36 participants
Primary outcome timeframe
Day 8
Results posted on
2015-04-01
Participant Flow
Participant milestones
| Measure |
Sequence 1
Treatment Period 1: 75 µg indacaterol maleate (lactose blend) + placebo to indacterol (PulmoSphereTM) delivered via the Concept1 device once daily in the morning for 7 days. Treatment Period 2: placebo to indacterol (lactose blend) + placebo to indacterol (PulmoSphereTM) delivered via the Concept1 device once daily in the morning for 7 days. Treatment Period 3: placebo to indacaterol (lactose blend) + 75 µg indacaterol (PulmoSphereTM) delivered via the Concept1 device once daily in the morning for 7 days. Treatment Period 4: placebo to indacaterol (lactose blend) + 37.5 µg Indacaterol (PulmoSphereTM) delivered via the Concept1 device once daily in the morning for 7 days. All participants took part in a 7 day run-in period. There was a minimum 14 day washout between each treatment period. Participants continued their current treatment with Inhaled corticosteroids. Inhaled short-acting B2-agonist salbutamol was available for use as rescue medication throughout the study.
|
Sequence 2
Treatment Period 1: placebo to indacaterol (lactose blend) + 75 µg indacaterol (PulmoSphereTM) delivered via the Concept1 device once daily in the morning for 7 days. Treatment Period 2: 75 µg indacaterol maleate (lactose blend) + placebo to indacterol (PulmoSphereTM ) delivered via the Concept1 device once daily in the morning for 7 days. Treatment Period 3: placebo to indacaterol (lactose blend) + 37.5 µg Indacaterol (PulmoSphereTM) delivered via the Concept1 device once daily in the morning for 7 days. Treatment Period 4: placebo to indacterol (lactose blend) + placebo to indacterol (PulmoSphereTM) delivered via the Concept1 device once daily in the morning for 7 days. All participants took part in a 7 day run-in period. There was a minimum 14 day washout between each treatment period. Participants continued their current treatment with Inhaled corticosteroids. Inhaled short-acting B2-agonist salbutamol was available for use as rescue medication throughout the study.
|
Sequence 3
Treatment Period 1: placebo to indacaterol (lactose blend) + 37.5 µg Indacaterol (PulmoSphereTM) delivered via the Concept1 device once daily in the morning for 7 days. Treatment Period 2: placebo to indacaterol (lactose blend) + 75 µg indacaterol (PulmoSphereTM) delivered via the Concept1 device once daily in the morning for 7 days. Treatment Period 3: placebo to indacterol (lactose blend) + placebo to indacterol (PulmoSphereTM) delivered via the Concept1 device once daily in the morning for 7 days. Treatment Period 4: 75 µg indacaterol maleate (lactose blend) + placebo to indacterol (PulmoSphereTM) delivered via the Concept1 device once daily in the morning for 7 days. All participants took part in a 7 day run-in period. There was a minimum 14 day washout between each treatment period. Participants continued their current treatment with Inhaled corticosteroids. Inhaled short-acting B2-agonist salbutamol was available for use as rescue medication throughout the study.
|
Sequence 4
Treatment Period 1: placebo to indacterol (lactose blend) + placebo to indacterol (PulmoSphereTM) delivered via the Concept1 device once daily in the morning for 7 days. Treatment Period 2: placebo to indacaterol (lactose blend) + 37.5 µg Indacaterol (PulmoSphereTM) delivered via the Concept1 device once daily in the morning for 7 days. Treatment Period 3: 75 µg indacaterol maleate (lactose blend) + placebo to indacterol (PulmoSphereTM) delivered via the Concept1 device once daily in the morning for 7 days. Treatment Period 4: placebo to indacaterol (lactose blend) + 75 µg indacaterol (PulmoSphereTM) delivered via the Concept1 device once daily in the morning for 7 days. All participants took part in a 7 day run-in period. There was a minimum 14 day washout between each treatment period. Participants continued their current treatment with Inhaled corticosteroids. Inhaled short-acting B2-agonist salbutamol was available for use as rescue medication throughout the study.
|
|---|---|---|---|---|
|
Treatment Period 1
STARTED
|
9
|
9
|
9
|
9
|
|
Treatment Period 1
COMPLETED
|
8
|
9
|
9
|
9
|
|
Treatment Period 1
NOT COMPLETED
|
1
|
0
|
0
|
0
|
|
Treatment Period 2
STARTED
|
7
|
8
|
9
|
9
|
|
Treatment Period 2
COMPLETED
|
7
|
8
|
9
|
8
|
|
Treatment Period 2
NOT COMPLETED
|
0
|
0
|
0
|
1
|
|
Treatment Period 3
STARTED
|
7
|
8
|
9
|
8
|
|
Treatment Period 3
COMPLETED
|
7
|
8
|
9
|
8
|
|
Treatment Period 3
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Treatment Period 4
STARTED
|
7
|
8
|
9
|
6
|
|
Treatment Period 4
COMPLETED
|
7
|
8
|
9
|
6
|
|
Treatment Period 4
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Sequence 1
Treatment Period 1: 75 µg indacaterol maleate (lactose blend) + placebo to indacterol (PulmoSphereTM) delivered via the Concept1 device once daily in the morning for 7 days. Treatment Period 2: placebo to indacterol (lactose blend) + placebo to indacterol (PulmoSphereTM) delivered via the Concept1 device once daily in the morning for 7 days. Treatment Period 3: placebo to indacaterol (lactose blend) + 75 µg indacaterol (PulmoSphereTM) delivered via the Concept1 device once daily in the morning for 7 days. Treatment Period 4: placebo to indacaterol (lactose blend) + 37.5 µg Indacaterol (PulmoSphereTM) delivered via the Concept1 device once daily in the morning for 7 days. All participants took part in a 7 day run-in period. There was a minimum 14 day washout between each treatment period. Participants continued their current treatment with Inhaled corticosteroids. Inhaled short-acting B2-agonist salbutamol was available for use as rescue medication throughout the study.
|
Sequence 2
Treatment Period 1: placebo to indacaterol (lactose blend) + 75 µg indacaterol (PulmoSphereTM) delivered via the Concept1 device once daily in the morning for 7 days. Treatment Period 2: 75 µg indacaterol maleate (lactose blend) + placebo to indacterol (PulmoSphereTM ) delivered via the Concept1 device once daily in the morning for 7 days. Treatment Period 3: placebo to indacaterol (lactose blend) + 37.5 µg Indacaterol (PulmoSphereTM) delivered via the Concept1 device once daily in the morning for 7 days. Treatment Period 4: placebo to indacterol (lactose blend) + placebo to indacterol (PulmoSphereTM) delivered via the Concept1 device once daily in the morning for 7 days. All participants took part in a 7 day run-in period. There was a minimum 14 day washout between each treatment period. Participants continued their current treatment with Inhaled corticosteroids. Inhaled short-acting B2-agonist salbutamol was available for use as rescue medication throughout the study.
|
Sequence 3
Treatment Period 1: placebo to indacaterol (lactose blend) + 37.5 µg Indacaterol (PulmoSphereTM) delivered via the Concept1 device once daily in the morning for 7 days. Treatment Period 2: placebo to indacaterol (lactose blend) + 75 µg indacaterol (PulmoSphereTM) delivered via the Concept1 device once daily in the morning for 7 days. Treatment Period 3: placebo to indacterol (lactose blend) + placebo to indacterol (PulmoSphereTM) delivered via the Concept1 device once daily in the morning for 7 days. Treatment Period 4: 75 µg indacaterol maleate (lactose blend) + placebo to indacterol (PulmoSphereTM) delivered via the Concept1 device once daily in the morning for 7 days. All participants took part in a 7 day run-in period. There was a minimum 14 day washout between each treatment period. Participants continued their current treatment with Inhaled corticosteroids. Inhaled short-acting B2-agonist salbutamol was available for use as rescue medication throughout the study.
|
Sequence 4
Treatment Period 1: placebo to indacterol (lactose blend) + placebo to indacterol (PulmoSphereTM) delivered via the Concept1 device once daily in the morning for 7 days. Treatment Period 2: placebo to indacaterol (lactose blend) + 37.5 µg Indacaterol (PulmoSphereTM) delivered via the Concept1 device once daily in the morning for 7 days. Treatment Period 3: 75 µg indacaterol maleate (lactose blend) + placebo to indacterol (PulmoSphereTM) delivered via the Concept1 device once daily in the morning for 7 days. Treatment Period 4: placebo to indacaterol (lactose blend) + 75 µg indacaterol (PulmoSphereTM) delivered via the Concept1 device once daily in the morning for 7 days. All participants took part in a 7 day run-in period. There was a minimum 14 day washout between each treatment period. Participants continued their current treatment with Inhaled corticosteroids. Inhaled short-acting B2-agonist salbutamol was available for use as rescue medication throughout the study.
|
|---|---|---|---|---|
|
Treatment Period 1
Adverse Event
|
1
|
0
|
0
|
0
|
|
Treatment Period 2
Subject withdrew consent
|
0
|
0
|
0
|
1
|
Baseline Characteristics
A Study to Evaluate the Effects of Indacaterol Maleate as a New Formulation in the Concept 1 Device
Baseline characteristics by cohort
| Measure |
All Participants
n=36 Participants
All participants randomized to one of four treatment sequences.
|
|---|---|
|
Age, Continuous
|
45.8 Years
STANDARD_DEVIATION 12.39 • n=99 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Day 8Population: Pharmacodynamics Analysis set included all participants that received at least one dose of study drug and had baseline and at least one post-baseline FEV1 measurement.
Spirometry was performed according to internationally accepted standards at Day 8. Trough FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. Trough FEV1 was defined as the average of the FEV1 measurements at 23 hours 10 minutes and 23 hours 45 minutes post dose.at Day 8. Analysis of Covariance with treatment, period, sequence and subject nested within sequence as fixed effects and period FEV1 baseline as a covariate.
Outcome measures
| Measure |
75 µg Indacaterol (LB)
n=33 Participants
75 µg indacaterol lactose blend (LB) delivered via the Concept1 device once daily in the morning for 7 days.
|
75 µg Indacaterol (PoS)
n=30 Participants
75 µg indacaterol PulmoSphereTM (PoS) delivered via the Concept1 device daily in the morning for 7 days.
|
37.5 µg Indacaterol (PoS)
n=32 Participants
37.5 µg indacaterol PulmoSphereTM (PoS) delivered via the Concept1 device in the morning for 7 days.
|
Placebo
n=33 Participants
Placebo to indacterol lactose blend or PulmoSphereTM delivered via the Concept1 device in the morning for 7 days.
|
|---|---|---|---|---|
|
Trough Forced Expiratory Volume in One Second (FEV1) After 7 Days of Treatment
|
2.84 Liters
Standard Error 0.03
|
2.83 Liters
Standard Error 0.03
|
2.80 Liters
Standard Error 0.03
|
2.64 Liters
Standard Error 0.03
|
SECONDARY outcome
Timeframe: Day 2Population: Pharmacodynamics Analysis set included all participants that received at least one dose of study drug and had baseline and at least one post-baseline FEV1 measurement.
Spirometry was performed according to internationally accepted standards at Day 2. Trough FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. Trough FEV1 was defined as the average of the FEV1 measurements at 23 hours 10 minutes and 23 hours 45 minutes post dose at Day 2. Analysis of Covariance with treatment, period, sequence and subject nested within sequence as fixed effects and period FEV1 baseline as a covariate.
Outcome measures
| Measure |
75 µg Indacaterol (LB)
n=34 Participants
75 µg indacaterol lactose blend (LB) delivered via the Concept1 device once daily in the morning for 7 days.
|
75 µg Indacaterol (PoS)
n=31 Participants
75 µg indacaterol PulmoSphereTM (PoS) delivered via the Concept1 device daily in the morning for 7 days.
|
37.5 µg Indacaterol (PoS)
n=33 Participants
37.5 µg indacaterol PulmoSphereTM (PoS) delivered via the Concept1 device in the morning for 7 days.
|
Placebo
n=33 Participants
Placebo to indacterol lactose blend or PulmoSphereTM delivered via the Concept1 device in the morning for 7 days.
|
|---|---|---|---|---|
|
Trough Forced Expiratory Volume in One Second (FEV1) After 1 Day of Treatment
|
2.83 Liters
Standard Error 0.03
|
2.84 Liters
Standard Error 0.03
|
2.81 Liters
Standard Error 0.03
|
2.62 Liters
Standard Error 0.03
|
SECONDARY outcome
Timeframe: Day 1, Day 7Population: Pharmacodynamics Analysis set included all participants that received at least one dose of study drug and had baseline and at least one post-baseline FEV1 measurement.
Spirometry was performed according to internationally accepted standards at 0, 15 and 30 minutes; 1,2,3,4,8,12 hours on Day 1 and 23.16 and 23.75 hours on Day 2 after 1 day of treatment and on Day 7 and Day 8 following 7 days of treatment. Peak FEV1 was the maximum FEV1 post treatment. Analysis of Covariance with treatment, period, sequence and subject nested within sequence as fixed effects and period FEV1 baseline included as a covariate.
Outcome measures
| Measure |
75 µg Indacaterol (LB)
n=34 Participants
75 µg indacaterol lactose blend (LB) delivered via the Concept1 device once daily in the morning for 7 days.
|
75 µg Indacaterol (PoS)
n=31 Participants
75 µg indacaterol PulmoSphereTM (PoS) delivered via the Concept1 device daily in the morning for 7 days.
|
37.5 µg Indacaterol (PoS)
n=33 Participants
37.5 µg indacaterol PulmoSphereTM (PoS) delivered via the Concept1 device in the morning for 7 days.
|
Placebo
n=33 Participants
Placebo to indacterol lactose blend or PulmoSphereTM delivered via the Concept1 device in the morning for 7 days.
|
|---|---|---|---|---|
|
Peak FEV1 at Day 1 and Day 7
Day 1
|
3.08 Liters
Interval 3.04 to 3.13
|
3.11 Liters
Interval 3.07 to 3.16
|
3.05 Liters
Interval 3.01 to 3.1
|
2.85 Liters
Interval 2.8 to 2.89
|
|
Peak FEV1 at Day 1 and Day 7
Day 7 (n=33,30,32,33)
|
3.09 Liters
Interval 3.05 to 3.13
|
3.11 Liters
Interval 3.06 to 3.15
|
3.10 Liters
Interval 3.06 to 3.14
|
2.89 Liters
Interval 2.85 to 2.93
|
SECONDARY outcome
Timeframe: Day 1, Day 7Population: Pharmacodynamics Analysis set included all participants that received at least one dose of study drug and had baseline and at least one post-baseline FEV1 measurement.
Spirometry was performed according to internationally accepted standards. Time to the peak (maximum) FEV1 is recorded. Analysis of Covariance with treatment, period, sequence and subject nested within sequence as fixed effects and period FEV1 baseline as a covariate.
Outcome measures
| Measure |
75 µg Indacaterol (LB)
n=34 Participants
75 µg indacaterol lactose blend (LB) delivered via the Concept1 device once daily in the morning for 7 days.
|
75 µg Indacaterol (PoS)
n=31 Participants
75 µg indacaterol PulmoSphereTM (PoS) delivered via the Concept1 device daily in the morning for 7 days.
|
37.5 µg Indacaterol (PoS)
n=33 Participants
37.5 µg indacaterol PulmoSphereTM (PoS) delivered via the Concept1 device in the morning for 7 days.
|
Placebo
n=33 Participants
Placebo to indacterol lactose blend or PulmoSphereTM delivered via the Concept1 device in the morning for 7 days.
|
|---|---|---|---|---|
|
Time to Peak FEV1 at Day 1 and Day 7
Day 1
|
3.98 Hours
Interval 0.25 to 23.77
|
3.02 Hours
Interval 0.25 to 23.75
|
3.00 Hours
Interval 0.25 to 23.75
|
3.00 Hours
Interval 0.25 to 24.77
|
|
Time to Peak FEV1 at Day 1 and Day 7
Day 7 (n=33,30,32,33)
|
3.00 Hours
Interval 0.22 to 23.82
|
3.05 Hours
Interval 0.25 to 23.77
|
3.00 Hours
Interval 0.98 to 23.78
|
3.97 Hours
Interval 0.25 to 23.77
|
SECONDARY outcome
Timeframe: Day 1, Day 2Population: Pharmacodynamics Analysis set included all participants that received at least one dose of study drug and had baseline and at least one post-baseline FEV1 measurement
Spirometry was conducted according to internationally accepted standards post-dose at 0, 15 and 30 minutes; 1, 2, 3, 4, 8, 12 hours on Day 1 and 23.16 and 23.75 hours on Day 2. FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation.
Outcome measures
| Measure |
75 µg Indacaterol (LB)
n=34 Participants
75 µg indacaterol lactose blend (LB) delivered via the Concept1 device once daily in the morning for 7 days.
|
75 µg Indacaterol (PoS)
n=31 Participants
75 µg indacaterol PulmoSphereTM (PoS) delivered via the Concept1 device daily in the morning for 7 days.
|
37.5 µg Indacaterol (PoS)
n=33 Participants
37.5 µg indacaterol PulmoSphereTM (PoS) delivered via the Concept1 device in the morning for 7 days.
|
Placebo
n=33 Participants
Placebo to indacterol lactose blend or PulmoSphereTM delivered via the Concept1 device in the morning for 7 days.
|
|---|---|---|---|---|
|
FEV1 at Each Time-Point on Day 1 and Day 2
2 hours post-dose
|
2.98 Liters
Standard Deviation 0.73
|
3.06 Liters
Standard Deviation 0.81
|
3.02 Liters
Standard Deviation 0.74
|
2.82 Liters
Standard Deviation 0.68
|
|
FEV1 at Each Time-Point on Day 1 and Day 2
0 minutes post-dose
|
2.61 Liters
Standard Deviation 0.71
|
2.65 Liters
Standard Deviation 0.70
|
2.68 Liters
Standard Deviation 0.68
|
2.67 Liters
Standard Deviation 0.69
|
|
FEV1 at Each Time-Point on Day 1 and Day 2
5 minutes post-dose
|
2.85 Liters
Standard Deviation 0.76
|
2.97 Liters
Standard Deviation 0.80
|
2.90 Liters
Standard Deviation 0.75
|
2.66 Liters
Standard Deviation 0.69
|
|
FEV1 at Each Time-Point on Day 1 and Day 2
30 minutes post-dose
|
2.86 Liters
Standard Deviation 0.76
|
2.96 Liters
Standard Deviation 0.75
|
2.93 Liters
Standard Deviation 0.73
|
2.70 Liters
Standard Deviation 0.71
|
|
FEV1 at Each Time-Point on Day 1 and Day 2
1 hour post-dose
|
2.89 Liters
Standard Deviation 0.76
|
3.03 Liters
Standard Deviation 0.80
|
2.95 Liters
Standard Deviation 0.75
|
2.73 Liters
Standard Deviation 0.72
|
|
FEV1 at Each Time-Point on Day 1 and Day 2
3 hours post-dose
|
2.98 Liters
Standard Deviation 0.76
|
3.09 Liters
Standard Deviation 0.80
|
3.05 Liters
Standard Deviation 0.75
|
2.80 Liters
Standard Deviation 0.69
|
|
FEV1 at Each Time-Point on Day 1 and Day 2
4 hours post-dose
|
2.99 Liters
Standard Deviation 0.73
|
3.07 Liters
Standard Deviation 0.81
|
3.00 Liters
Standard Deviation 0.75
|
2.77 Liters
Standard Deviation 0.67
|
|
FEV1 at Each Time-Point on Day 1 and Day 2
8 hours post-dose
|
2.80 Liters
Standard Deviation 0.60
|
2.99 Liters
Standard Deviation 0.83
|
2.89 Liters
Standard Deviation 0.79
|
2.70 Liters
Standard Deviation 0.68
|
|
FEV1 at Each Time-Point on Day 1 and Day 2
12 hours post-dose
|
2.74 Liters
Standard Deviation 0.65
|
2.92 Liters
Standard Deviation 0.79
|
2.85 Liters
Standard Deviation 0.79
|
2.71 Liters
Standard Deviation 0.67
|
|
FEV1 at Each Time-Point on Day 1 and Day 2
23.16 hours post-dose
|
2.81 Liters
Standard Deviation 0.74
|
2.85 Liters
Standard Deviation 0.77
|
2.83 Liters
Standard Deviation 0.76
|
2.59 Liters
Standard Deviation 0.69
|
|
FEV1 at Each Time-Point on Day 1 and Day 2
23.75 hours post-dose
|
2.89 Liters
Standard Deviation 0.75
|
2.88 Liters
Standard Deviation 0.80
|
2.85 Liters
Standard Deviation 0.72
|
2.68 Liters
Standard Deviation 0.69
|
SECONDARY outcome
Timeframe: Day 7, Day 8Population: Pharmacodynamics Analysis set included all participants that received at least one dose of study drug and had baseline and at least one post-baseline FEV1 measurement
Spirometry was conducted according to internationally accepted standards at 0, 15 and 30 minutes; 1,2,3,4,8,12 hours on Day 7 and 23.16 and 23.75 hours on Day 8. FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation.
Outcome measures
| Measure |
75 µg Indacaterol (LB)
n=33 Participants
75 µg indacaterol lactose blend (LB) delivered via the Concept1 device once daily in the morning for 7 days.
|
75 µg Indacaterol (PoS)
n=30 Participants
75 µg indacaterol PulmoSphereTM (PoS) delivered via the Concept1 device daily in the morning for 7 days.
|
37.5 µg Indacaterol (PoS)
n=32 Participants
37.5 µg indacaterol PulmoSphereTM (PoS) delivered via the Concept1 device in the morning for 7 days.
|
Placebo
n=33 Participants
Placebo to indacterol lactose blend or PulmoSphereTM delivered via the Concept1 device in the morning for 7 days.
|
|---|---|---|---|---|
|
FEV1 at Each Time-Point on Day 7 and Day 8
23.16 hours post-dose
|
2.79 Liters
Standard Deviation 0.71
|
2.79 Liters
Standard Deviation 0.77
|
2.79 Liters
Standard Deviation 0.79
|
2.64 Liters
Standard Deviation 0.68
|
|
FEV1 at Each Time-Point on Day 7 and Day 8
0 minutes post-dose
|
2.80 Liters
Standard Deviation 0.77
|
2.79 Liters
Standard Deviation 0.72
|
2.85 Liters
Standard Deviation 0.73
|
2.63 Liters
Standard Deviation 0.67
|
|
FEV1 at Each Time-Point on Day 7 and Day 8
15 minutes post-dose
|
2.87 Liters
Standard Deviation 0.80
|
2.88 Liters
Standard Deviation 0.77
|
2.92 Liters
Standard Deviation 0.76
|
2.65 Liters
Standard Deviation 0.72
|
|
FEV1 at Each Time-Point on Day 7 and Day 8
30 minutes post-dose
|
2.91 Liters
Standard Deviation 0.79
|
2.92 Liters
Standard Deviation 0.76
|
2.94 Liters
Standard Deviation 0.77
|
2.64 Liters
Standard Deviation 0.72
|
|
FEV1 at Each Time-Point on Day 7 and Day 8
1 hour post-dose
|
2.94 Liters
Standard Deviation 0.75
|
2.96 Liters
Standard Deviation 0.77
|
2.97 Liters
Standard Deviation 0.76
|
2.72 Liters
Standard Deviation 0.70
|
|
FEV1 at Each Time-Point on Day 7 and Day 8
2 hours post-dose
|
2.99 Liters
Standard Deviation 0.76
|
3.00 Liters
Standard Deviation 0.72
|
3.00 Liters
Standard Deviation 0.73
|
2.79 Liters
Standard Deviation 0.72
|
|
FEV1 at Each Time-Point on Day 7 and Day 8
3 hours post-dose
|
2.99 Liters
Standard Deviation 0.74
|
2.99 Liters
Standard Deviation 0.75
|
3.06 Liters
Standard Deviation 0.75
|
2.79 Liters
Standard Deviation 0.72
|
|
FEV1 at Each Time-Point on Day 7 and Day 8
4 hours post-dose
|
2.98 Liters
Standard Deviation 0.75
|
2.98 Liters
Standard Deviation 0.73
|
3.02 Liters
Standard Deviation 0.70
|
2.78 Liters
Standard Deviation 0.70
|
|
FEV1 at Each Time-Point on Day 7 and Day 8
8 hours post-dose
|
2.82 Liters
Standard Deviation 0.64
|
2.88 Liters
Standard Deviation 0.77
|
2.89 Liters
Standard Deviation 0.75
|
2.76 Liters
Standard Deviation 0.65
|
|
FEV1 at Each Time-Point on Day 7 and Day 8
12 hours post-dose
|
2.76 Liters
Standard Deviation 0.66
|
2.80 Liters
Standard Deviation 0.78
|
2.82 Liters
Standard Deviation 0.76
|
2.65 Liters
Standard Deviation 0.70
|
|
FEV1 at Each Time-Point on Day 7 and Day 8
23.75 hours post-dose
|
2.89 Liters
Standard Deviation 0.72
|
2.87 Liters
Standard Deviation 0.76
|
2.87 Liters
Standard Deviation 0.74
|
2.74 Liters
Standard Deviation 0.68
|
SECONDARY outcome
Timeframe: Day 1, Day 2Population: Pharmacodynamics Analysis set included all participants that received at least one dose of study drug and had baseline and at least one post-baseline FEV1 measurement
Spirometry was conducted according to internationally accepted standards post-dose at 0, 15 and 30 minutes; 1, 2, 3, 4, 8 and 12 hours on Day 1 and 23.16 and 23.75 hours on Day 2. FVC is the amount of air that can be forcibly exhaled from the lungs after taking the deepest breath possible.
Outcome measures
| Measure |
75 µg Indacaterol (LB)
n=34 Participants
75 µg indacaterol lactose blend (LB) delivered via the Concept1 device once daily in the morning for 7 days.
|
75 µg Indacaterol (PoS)
n=31 Participants
75 µg indacaterol PulmoSphereTM (PoS) delivered via the Concept1 device daily in the morning for 7 days.
|
37.5 µg Indacaterol (PoS)
n=33 Participants
37.5 µg indacaterol PulmoSphereTM (PoS) delivered via the Concept1 device in the morning for 7 days.
|
Placebo
n=33 Participants
Placebo to indacterol lactose blend or PulmoSphereTM delivered via the Concept1 device in the morning for 7 days.
|
|---|---|---|---|---|
|
Forced Vital Capacity (FVC) at Each Time-Point on Day 1 and Day 2
0 minutes post-dose
|
4.11 Liters
Standard Deviation 1.02
|
4.30 Liters
Standard Deviation 0.98
|
4.23 Liters
Standard Deviation 1.03
|
4.27 Liters
Standard Deviation 1.02
|
|
Forced Vital Capacity (FVC) at Each Time-Point on Day 1 and Day 2
15 minutes post-dose
|
4.29 Liters
Standard Deviation 1.07
|
4.52 Liters
Standard Deviation 1.10
|
4.34 Liters
Standard Deviation 1.04
|
4.25 Liters
Standard Deviation 1.03
|
|
Forced Vital Capacity (FVC) at Each Time-Point on Day 1 and Day 2
30 minutes post-dose
|
4.29 Liters
Standard Deviation 1.03
|
4.47 Liters
Standard Deviation 1.02
|
4.39 Liters
Standard Deviation 1.01
|
4.18 Liters
Standard Deviation 1.07
|
|
Forced Vital Capacity (FVC) at Each Time-Point on Day 1 and Day 2
1 hour post-dose
|
4.33 Liters
Standard Deviation 1.06
|
4.49 Liters
Standard Deviation 1.05
|
4.38 Liters
Standard Deviation 1.06
|
4.30 Liters
Standard Deviation 1.06
|
|
Forced Vital Capacity (FVC) at Each Time-Point on Day 1 and Day 2
2 hours post-dose
|
4.39 Liters
Standard Deviation 0.99
|
4.54 Liters
Standard Deviation 1.07
|
4.45 Liters
Standard Deviation 1.02
|
4.36 Liters
Standard Deviation 0.97
|
|
Forced Vital Capacity (FVC) at Each Time-Point on Day 1 and Day 2
3 hours post-dose
|
4.38 Liters
Standard Deviation 1.04
|
4.52 Liters
Standard Deviation 1.05
|
4.44 Liters
Standard Deviation 0.98
|
4.33 Liters
Standard Deviation 0.98
|
|
Forced Vital Capacity (FVC) at Each Time-Point on Day 1 and Day 2
4 hours post-dose
|
4.39 Liters
Standard Deviation 1.01
|
4.54 Liters
Standard Deviation 1.06
|
4.40 Liters
Standard Deviation 1.01
|
4.30 Liters
Standard Deviation 0.98
|
|
Forced Vital Capacity (FVC) at Each Time-Point on Day 1 and Day 2
8 hours post-dose
|
4.20 Liters
Standard Deviation 0.86
|
4.51 Liters
Standard Deviation 1.09
|
4.35 Liters
Standard Deviation 1.07
|
4.21 Liters
Standard Deviation 1.01
|
|
Forced Vital Capacity (FVC) at Each Time-Point on Day 1 and Day 2
12 hours post-dose
|
4.16 Liters
Standard Deviation 0.93
|
4.42 Liters
Standard Deviation 1.05
|
4.29 Liters
Standard Deviation 1.04
|
4.24 Liters
Standard Deviation 1.02
|
|
Forced Vital Capacity (FVC) at Each Time-Point on Day 1 and Day 2
23.16 hours post-dose
|
4.34 Liters
Standard Deviation 1.06
|
4.44 Liters
Standard Deviation 1.08
|
4.31 Liters
Standard Deviation 1.08
|
4.21 Liters
Standard Deviation 0.99
|
|
Forced Vital Capacity (FVC) at Each Time-Point on Day 1 and Day 2
23.75 hours post-dose
|
4.41 Liters
Standard Deviation 1.06
|
4.41 Liters
Standard Deviation 1.10
|
4.36 Liters
Standard Deviation 1.08
|
4.30 Liters
Standard Deviation 0.99
|
SECONDARY outcome
Timeframe: Day 7, Day 8Population: Pharmacodynamics Analysis set included all participants that received at least one dose of study drug and had baseline and at least one post-baseline FEV1 measurement
Spirometry was conducted according to internationally accepted standards post-dose at 0, 15 and 30 minutes; 1, 2, 3, 4, 8 and 12 hours on Day 7 and 23.16 and 23.75 hours on Day 8. FVC is the amount of air that can be forcibly exhaled from the lungs after taking the deepest breath possible.
Outcome measures
| Measure |
75 µg Indacaterol (LB)
n=33 Participants
75 µg indacaterol lactose blend (LB) delivered via the Concept1 device once daily in the morning for 7 days.
|
75 µg Indacaterol (PoS)
n=30 Participants
75 µg indacaterol PulmoSphereTM (PoS) delivered via the Concept1 device daily in the morning for 7 days.
|
37.5 µg Indacaterol (PoS)
n=32 Participants
37.5 µg indacaterol PulmoSphereTM (PoS) delivered via the Concept1 device in the morning for 7 days.
|
Placebo
n=33 Participants
Placebo to indacterol lactose blend or PulmoSphereTM delivered via the Concept1 device in the morning for 7 days.
|
|---|---|---|---|---|
|
Forced Vital Capacity (FVC) at Each Time-Point on Day 7 and Day 8
8 hours post-dose
|
4.24 Liters
Standard Deviation 0.97
|
4.29 Liters
Standard Deviation 0.94
|
4.31 Liters
Standard Deviation 1.05
|
4.31 Liters
Standard Deviation 1.01
|
|
Forced Vital Capacity (FVC) at Each Time-Point on Day 7 and Day 8
12 hours post-dose
|
4.17 Liters
Standard Deviation 0.98
|
4.23 Liters
Standard Deviation 0.94
|
4.25 Liters
Standard Deviation 1.04
|
4.21 Liters
Standard Deviation 1.03
|
|
Forced Vital Capacity (FVC) at Each Time-Point on Day 7 and Day 8
23.16 hours post-dose
|
4.32 Liters
Standard Deviation 1.08
|
4.30 Liters
Standard Deviation 0.97
|
4.29 Liters
Standard Deviation 1.08
|
4.28 Liters
Standard Deviation 1.02
|
|
Forced Vital Capacity (FVC) at Each Time-Point on Day 7 and Day 8
23.75 hours post-dose
|
4.41 Liters
Standard Deviation 1.08
|
4.34 Liters
Standard Deviation 0.97
|
4.34 Liters
Standard Deviation 1.08
|
4.36 Liters
Standard Deviation 1.02
|
|
Forced Vital Capacity (FVC) at Each Time-Point on Day 7 and Day 8
0 minutes post-dose
|
4.28 Liters
Standard Deviation 1.07
|
4.30 Liters
Standard Deviation 0.93
|
4.35 Liters
Standard Deviation 1.06
|
4.22 Liters
Standard Deviation 1.00
|
|
Forced Vital Capacity (FVC) at Each Time-Point on Day 7 and Day 8
15 minutes post-dose
|
4.34 Liters
Standard Deviation 1.09
|
4.33 Liters
Standard Deviation 0.95
|
4.36 Liters
Standard Deviation 1.06
|
4.21 Liters
Standard Deviation 1.04
|
|
Forced Vital Capacity (FVC) at Each Time-Point on Day 7 and Day 8
30 minutes post-dose
|
4.36 Liters
Standard Deviation 1.08
|
4.36 Liters
Standard Deviation 0.96
|
4.37 Liters
Standard Deviation 1.06
|
4.21 Liters
Standard Deviation 1.04
|
|
Forced Vital Capacity (FVC) at Each Time-Point on Day 7 and Day 8
1 hour post-dose
|
4.37 Liters
Standard Deviation 1.06
|
4.35 Liters
Standard Deviation 0.97
|
4.41 Liters
Standard Deviation 1.05
|
4.28 Liters
Standard Deviation 1.03
|
|
Forced Vital Capacity (FVC) at Each Time-Point on Day 7 and Day 8
2 hours post-dose
|
4.39 Liters
Standard Deviation 1.04
|
4.40 Liters
Standard Deviation 0.90
|
4.42 Liters
Standard Deviation 1.02
|
4.37 Liters
Standard Deviation 1.06
|
|
Forced Vital Capacity (FVC) at Each Time-Point on Day 7 and Day 8
3 hours post-dose
|
4.37 Liters
Standard Deviation 1.01
|
4.40 Liters
Standard Deviation 0.93
|
4.46 Liters
Standard Deviation 1.03
|
4.34 Liters
Standard Deviation 1.05
|
|
Forced Vital Capacity (FVC) at Each Time-Point on Day 7 and Day 8
4 hours post-dose
|
4.38 Liters
Standard Deviation 1.05
|
4.39 Liters
Standard Deviation 0.91
|
4.44 Liters
Standard Deviation 0.99
|
4.32 Liters
Standard Deviation 1.03
|
SECONDARY outcome
Timeframe: Day1, Day 2Population: Pharmacodynamics Analysis set included all participants that received at least one dose of study drug and had baseline and at least one post-baseline FEV1 measurement
Spirometry was conducted according to internationally accepted standards post-dose at 0, 15 and 30 minutes; 1, 2, 3, 4, 8 and 12 hours on Day 1 and 23.16 and 23.75 hours on Day 2. FEV1/FVC ratio is the percentage of the total FVC that is expelled from the lungs during the first second of forced exhalation.
Outcome measures
| Measure |
75 µg Indacaterol (LB)
n=34 Participants
75 µg indacaterol lactose blend (LB) delivered via the Concept1 device once daily in the morning for 7 days.
|
75 µg Indacaterol (PoS)
n=34 Participants
75 µg indacaterol PulmoSphereTM (PoS) delivered via the Concept1 device daily in the morning for 7 days.
|
37.5 µg Indacaterol (PoS)
n=34 Participants
37.5 µg indacaterol PulmoSphereTM (PoS) delivered via the Concept1 device in the morning for 7 days.
|
Placebo
n=34 Participants
Placebo to indacterol lactose blend or PulmoSphereTM delivered via the Concept1 device in the morning for 7 days.
|
|---|---|---|---|---|
|
FEV1/FVC at Each Post-Dose Time Point on Day 1 and Day 2
8 hours post-dose
|
0.67 Ratio
Standard Deviation 0.07
|
0.66 Ratio
Standard Deviation 0.07
|
0.67 Ratio
Standard Deviation 0.08
|
0.64 Ratio
Standard Deviation 0.07
|
|
FEV1/FVC at Each Post-Dose Time Point on Day 1 and Day 2
0 minutes post-dose
|
0.63 Ratio
Standard Deviation 0.08
|
0.62 Ratio
Standard Deviation 0.08
|
0.64 Ratio
Standard Deviation 0.09
|
0.63 Ratio
Standard Deviation 0.09
|
|
FEV1/FVC at Each Post-Dose Time Point on Day 1 and Day 2
15 minutes post-dose
|
0.67 Ratio
Standard Deviation 0.08
|
0.66 Ratio
Standard Deviation 0.07
|
0.67 Ratio
Standard Deviation 0.09
|
0.63 Ratio
Standard Deviation 0.09
|
|
FEV1/FVC at Each Post-Dose Time Point on Day 1 and Day 2
30 minutes post-dose
|
0.67 Ratio
Standard Deviation 0.07
|
0.66 Ratio
Standard Deviation 0.07
|
0.67 Ratio
Standard Deviation 0.08
|
0.65 Ratio
Standard Deviation 0.09
|
|
FEV1/FVC at Each Post-Dose Time Point on Day 1 and Day 2
1 hour post-dose
|
0.67 Ratio
Standard Deviation 0.07
|
0.67 Ratio
Standard Deviation 0.07
|
0.68 Ratio
Standard Deviation 0.08
|
0.64 Ratio
Standard Deviation 0.08
|
|
FEV1/FVC at Each Post-Dose Time Point on Day 1 and Day 2
2 hours post-dose
|
0.68 Ratio
Standard Deviation 0.08
|
0.67 Ratio
Standard Deviation 0.07
|
0.68 Ratio
Standard Deviation 0.08
|
0.65 Ratio
Standard Deviation 0.08
|
|
FEV1/FVC at Each Post-Dose Time Point on Day 1 and Day 2
3 hours post-dose
|
0.68 Ratio
Standard Deviation 0.08
|
0.68 Ratio
Standard Deviation 0.07
|
0.69 Ratio
Standard Deviation 0.08
|
0.65 Ratio
Standard Deviation 0.08
|
|
FEV1/FVC at Each Post-Dose Time Point on Day 1 and Day 2
4 hours post-dose
|
0.68 Ratio
Standard Deviation 0.08
|
0.67 Ratio
Standard Deviation 0.07
|
0.68 Ratio
Standard Deviation 0.08
|
0.65 Ratio
Standard Deviation 0.08
|
|
FEV1/FVC at Each Post-Dose Time Point on Day 1 and Day 2
12 hours post-dose
|
0.66 Ratio
Standard Deviation 0.08
|
0.66 Ratio
Standard Deviation 0.07
|
0.66 Ratio
Standard Deviation 0.08
|
0.64 Ratio
Standard Deviation 0.08
|
|
FEV1/FVC at Each Post-Dose Time Point on Day 1 and Day 2
23.16 hours post-dose
|
0.65 Ratio
Standard Deviation 0.09
|
0.64 Ratio
Standard Deviation 0.08
|
0.66 Ratio
Standard Deviation 0.09
|
0.62 Ratio
Standard Deviation 0.09
|
|
FEV1/FVC at Each Post-Dose Time Point on Day 1 and Day 2
23.75 hours post-dose
|
0.66 Ratio
Standard Deviation 0.08
|
0.65 Ratio
Standard Deviation 0.08
|
0.66 Ratio
Standard Deviation 0.08
|
0.63 Ratio
Standard Deviation 0.08
|
SECONDARY outcome
Timeframe: Day 7, Day 8Population: Pharmacodynamics Analysis set included all participants that received at least one dose of study drug and had baseline and at least one post-baseline FEV1 measurement.
Spirometry was conducted according to internationally accepted standards post-dose at 0, 15 and 30 minutes; 1, 2, 3, 4, 8 and 12 hours on Day 1 and 23.16 and 23.75 hours on Day 2 after treatment. FEV1/FVC ratio is the percentage of the total FVC that is expelled from the lungs during the first second of forced exhalation.
Outcome measures
| Measure |
75 µg Indacaterol (LB)
n=33 Participants
75 µg indacaterol lactose blend (LB) delivered via the Concept1 device once daily in the morning for 7 days.
|
75 µg Indacaterol (PoS)
n=30 Participants
75 µg indacaterol PulmoSphereTM (PoS) delivered via the Concept1 device daily in the morning for 7 days.
|
37.5 µg Indacaterol (PoS)
n=32 Participants
37.5 µg indacaterol PulmoSphereTM (PoS) delivered via the Concept1 device in the morning for 7 days.
|
Placebo
n=33 Participants
Placebo to indacterol lactose blend or PulmoSphereTM delivered via the Concept1 device in the morning for 7 days.
|
|---|---|---|---|---|
|
FEV1/FVC at Each Post-dose Time Point on Day 7 and Day 8
1 hour post-dose
|
0.67 Ratio
Standard Deviation 0.07
|
0.68 Ratio
Standard Deviation 0.07
|
0.67 Ratio
Standard Deviation 0.07
|
0.64 Ratio
Standard Deviation 0.08
|
|
FEV1/FVC at Each Post-dose Time Point on Day 7 and Day 8
0 minutes post-dose
|
0.65 Ratio
Standard Deviation 0.08
|
0.65 Ratio
Standard Deviation 0.07
|
0.65 Ratio
Standard Deviation 0.08
|
0.62 Ratio
Standard Deviation 0.08
|
|
FEV1/FVC at Each Post-dose Time Point on Day 7 and Day 8
15 minutes post-dose
|
0.66 Ratio
Standard Deviation 0.08
|
0.66 Ratio
Standard Deviation 0.07
|
0.67 Ratio
Standard Deviation 0.07
|
0.63 Ratio
Standard Deviation 0.08
|
|
FEV1/FVC at Each Post-dose Time Point on Day 7 and Day 8
30 minutes post-dose
|
0.67 Ratio
Standard Deviation 0.08
|
0.67 Ratio
Standard Deviation 0.06
|
0.67 Ratio
Standard Deviation 0.07
|
0.63 Ratio
Standard Deviation 0.09
|
|
FEV1/FVC at Each Post-dose Time Point on Day 7 and Day 8
2 hours post-dose
|
0.68 Ratio
Standard Deviation 0.07
|
0.68 Ratio
Standard Deviation 0.06
|
0.68 Ratio
Standard Deviation 0.07
|
0.64 Ratio
Standard Deviation 0.08
|
|
FEV1/FVC at Each Post-dose Time Point on Day 7 and Day 8
3 hours post-dose
|
0.68 Ratio
Standard Deviation 0.07
|
0.68 Ratio
Standard Deviation 0.07
|
0.69 Ratio
Standard Deviation 0.08
|
0.65 Ratio
Standard Deviation 0.09
|
|
FEV1/FVC at Each Post-dose Time Point on Day 7 and Day 8
4 hours post-dose
|
0.68 Ratio
Standard Deviation 0.07
|
0.68 Ratio
Standard Deviation 0.07
|
0.68 Ratio
Standard Deviation 0.07
|
0.64 Ratio
Standard Deviation 0.08
|
|
FEV1/FVC at Each Post-dose Time Point on Day 7 and Day 8
8 hours post-dose
|
0.66 Ratio
Standard Deviation 0.07
|
0.67 Ratio
Standard Deviation 0.07
|
0.67 Ratio
Standard Deviation 0.08
|
0.64 Ratio
Standard Deviation 0.08
|
|
FEV1/FVC at Each Post-dose Time Point on Day 7 and Day 8
12 hours post-dose
|
0.66 Ratio
Standard Deviation 0.08
|
0.66 Ratio
Standard Deviation 0.07
|
0.66 Ratio
Standard Deviation 0.08
|
0.63 Ratio
Standard Deviation 0.08
|
|
FEV1/FVC at Each Post-dose Time Point on Day 7 and Day 8
23.16 hours post-dose
|
0.64 Ratio
Standard Deviation 0.67
|
0.65 Ratio
Standard Deviation 0.08
|
0.65 Ratio
Standard Deviation 0.08
|
0.62 Ratio
Standard Deviation 0.09
|
|
FEV1/FVC at Each Post-dose Time Point on Day 7 and Day 8
23.75 hours post-dose
|
0.65 Ratio
Standard Deviation 0.72
|
0.66 Ratio
Standard Deviation 0.07
|
0.66 Ratio
Standard Deviation 0.08
|
0.63 Ratio
Standard Deviation 0.09
|
SECONDARY outcome
Timeframe: Day 1, Day 2Population: Pharmacodynamics Analysis set included all participants that received at least one dose of study drug and had baseline and at least one post-baseline FEV1 measurement
Spirometry was conducted according to internationally accepted standards post-dose at 0, 15 and 30 minutes; 1, 2, 3, 4, 8 and 12 hours on Day 1 and 23.16 and 23.75 hours on Day 2. The forced expiratory flow (FEF) 25%-75% measurement describes the amount of air expelled from the lungs during the middle half (25% - 75%) of the forced vital capacity test and is measured using spirometry.
Outcome measures
| Measure |
75 µg Indacaterol (LB)
n=34 Participants
75 µg indacaterol lactose blend (LB) delivered via the Concept1 device once daily in the morning for 7 days.
|
75 µg Indacaterol (PoS)
n=31 Participants
75 µg indacaterol PulmoSphereTM (PoS) delivered via the Concept1 device daily in the morning for 7 days.
|
37.5 µg Indacaterol (PoS)
n=33 Participants
37.5 µg indacaterol PulmoSphereTM (PoS) delivered via the Concept1 device in the morning for 7 days.
|
Placebo
n=33 Participants
Placebo to indacterol lactose blend or PulmoSphereTM delivered via the Concept1 device in the morning for 7 days.
|
|---|---|---|---|---|
|
Forced Expiratory Flow 25- 75% (FEF25-75) on Day 1 and Day 2
0 minutes post-dose
|
1.55 Liters/second
Standard Deviation 0.68
|
1.52 Liters/second
Standard Deviation 0.70
|
1.54 Liters/second
Standard Deviation 0.67
|
1.56 Liters/second
Standard Deviation 0.71
|
|
Forced Expiratory Flow 25- 75% (FEF25-75) on Day 1 and Day 2
15 minutes post-dose
|
1.78 Liters/second
Standard Deviation 0.75
|
1.81 Liters/second
Standard Deviation 0.79
|
1.82 Liters/second
Standard Deviation 0.77
|
1.54 Liters/second
Standard Deviation 0.72
|
|
Forced Expiratory Flow 25- 75% (FEF25-75) on Day 1 and Day 2
30 minutes post-dose
|
1.80 Liters/second
Standard Deviation 0.80
|
1.82 Liters/second
Standard Deviation 0.77
|
1.84 Liters/second
Standard Deviation 0.73
|
1.61 Liters/second
Standard Deviation 0.74
|
|
Forced Expiratory Flow 25- 75% (FEF25-75) on Day 1 and Day 2
1 hour post-dose
|
1.79 Liters/second
Standard Deviation 0.77
|
1.95 Liters/second
Standard Deviation 0.85
|
1.89 Liters/second
Standard Deviation 0.75
|
1.59 Liters/second
Standard Deviation 0.73
|
|
Forced Expiratory Flow 25- 75% (FEF25-75) on Day 1 and Day 2
2 hours post-dose
|
1.90 Liters/second
Standard Deviation 0.80
|
1.93 Liters/second
Standard Deviation 0.84
|
1.92 Liters/second
Standard Deviation 0.79
|
1.68 Liters/second
Standard Deviation 0.74
|
|
Forced Expiratory Flow 25- 75% (FEF25-75) on Day 1 and Day 2
3 hours post-dose
|
1.89 Liters/second
Standard Deviation 0.81
|
2.01 Liters/second
Standard Deviation 0.83
|
1.99 Liters/second
Standard Deviation 0.85
|
1.68 Liters/second
Standard Deviation 0.77
|
|
Forced Expiratory Flow 25- 75% (FEF25-75) on Day 1 and Day 2
4 hours post-dose
|
1.94 Liters/second
Standard Deviation 0.82
|
1.94 Liters/second
Standard Deviation 0.85
|
1.92 Liters/second
Standard Deviation 0.80
|
1.65 Liters/second
Standard Deviation 0.70
|
|
Forced Expiratory Flow 25- 75% (FEF25-75) on Day 1 and Day 2
8 hours post-dose
|
1.71 Liters/second
Standard Deviation 0.69
|
1.83 Liters/second
Standard Deviation 0.84
|
1.79 Liters/second
Standard Deviation 0.81
|
1.59 Liters/second
Standard Deviation 0.66
|
|
Forced Expiratory Flow 25- 75% (FEF25-75) on Day 1 and Day 2
12 hours post-dose
|
1.63 Liters/second
Standard Deviation 0.65
|
1.77 Liters/second
Standard Deviation 0.78
|
1.76 Liters/second
Standard Deviation 0.83
|
1.61 Liters/second
Standard Deviation 0.69
|
|
Forced Expiratory Flow 25- 75% (FEF25-75) on Day 1 and Day 2
23.16 hours post-dose
|
1.70 Liters/second
Standard Deviation 0.77
|
1.68 Liters/second
Standard Deviation 0.75
|
1.78 Liters/second
Standard Deviation 0.80
|
1.51 Liters/second
Standard Deviation 0.70
|
|
Forced Expiratory Flow 25- 75% (FEF25-75) on Day 1 and Day 2
23.75 hours post-dose
|
1.77 Liters/second
Standard Deviation 0.74
|
1.76 Liters/second
Standard Deviation 0.77
|
1.75 Liters/second
Standard Deviation 0.71
|
1.56 Liters/second
Standard Deviation 0.71
|
SECONDARY outcome
Timeframe: Day 7, Day 8Population: Pharmacodynamics Analysis set included all participants that received at least one dose of study drug and had baseline and at least one post-baseline FEV1 measurement
Spirometry was conducted according to internationally accepted standards post-dose at 0, 15 and 30 minutes; 1, 2, 3, 4, 8 and 12 hours on Day 7 and 23.16 and 23.75 hours on Day 8. The forced expiratory flow (FEF) 25%-75% measurement describes the amount of air expelled from the lungs during the middle half (25% - 75%) of the forced vital capacity test and is measured using spirometry.
Outcome measures
| Measure |
75 µg Indacaterol (LB)
n=33 Participants
75 µg indacaterol lactose blend (LB) delivered via the Concept1 device once daily in the morning for 7 days.
|
75 µg Indacaterol (PoS)
n=30 Participants
75 µg indacaterol PulmoSphereTM (PoS) delivered via the Concept1 device daily in the morning for 7 days.
|
37.5 µg Indacaterol (PoS)
n=32 Participants
37.5 µg indacaterol PulmoSphereTM (PoS) delivered via the Concept1 device in the morning for 7 days.
|
Placebo
n=33 Participants
Placebo to indacterol lactose blend or PulmoSphereTM delivered via the Concept1 device in the morning for 7 days.
|
|---|---|---|---|---|
|
Forced Expiratory Flow 25- 75% (FEF25-75) on Day 7 and Day 8
2 hours post-dose
|
1.88 Liters/second
Standard Deviation 0.80
|
1.89 Liters/second
Standard Deviation 0.77
|
1.91 Liters/second
Standard Deviation 0.82
|
1.64 Liters/second
Standard Deviation 0.72
|
|
Forced Expiratory Flow 25- 75% (FEF25-75) on Day 7 and Day 8
3 hours post-dose
|
1.91 Liters/second
Standard Deviation 0.80
|
1.88 Liters/second
Standard Deviation 0.81
|
2.02 Liters/second
Standard Deviation 0.82
|
1.69 Liters/second
Standard Deviation 0.70
|
|
Forced Expiratory Flow 25- 75% (FEF25-75) on Day 7 and Day 8
1 hour post-dose
|
1.82 Liters/second
Standard Deviation 0.77
|
1.89 Liters/second
Standard Deviation 0.84
|
1.87 Liters/second
Standard Deviation 0.80
|
1.61 Liters/second
Standard Deviation 0.69
|
|
Forced Expiratory Flow 25- 75% (FEF25-75) on Day 7 and Day 8
0 minutes post-dose
|
1.70 Liters/second
Standard Deviation 0.75
|
1.69 Liters/second
Standard Deviation 0.76
|
1.71 Liters/second
Standard Deviation 0.78
|
1.51 Liters/second
Standard Deviation 0.67
|
|
Forced Expiratory Flow 25- 75% (FEF25-75) on Day 7 and Day 8
15 minutes post-dose
|
1.76 Liters/second
Standard Deviation 0.83
|
1.78 Liters/second
Standard Deviation 0.82
|
1.83 Liters/second
Standard Deviation 0.80
|
1.54 Liters/second
Standard Deviation 0.73
|
|
Forced Expiratory Flow 25- 75% (FEF25-75) on Day 7 and Day 8
30 minutes post-dose
|
1.80 Liters/second
Standard Deviation 0.79
|
1.80 Liters/second
Standard Deviation 0.82
|
1.83 Liters/second
Standard Deviation 0.81
|
1.57 Liters/second
Standard Deviation 0.72
|
|
Forced Expiratory Flow 25- 75% (FEF25-75) on Day 7 and Day 8
4 hours post-dose
|
1.90 Liters/second
Standard Deviation 0.82
|
1.88 Liters/second
Standard Deviation 0.82
|
1.93 Liters/second
Standard Deviation 0.83
|
1.65 Liters/second
Standard Deviation 0.73
|
|
Forced Expiratory Flow 25- 75% (FEF25-75) on Day 7 and Day 8
8 hours post-dose
|
1.71 Liters/second
Standard Deviation 0.66
|
1.80 Liters/second
Standard Deviation 0.82
|
1.81 Liters/second
Standard Deviation 0.82
|
1.64 Liters/second
Standard Deviation 0.67
|
|
Forced Expiratory Flow 25- 75% (FEF25-75) on Day 7 and Day 8
12 hours post-dose
|
1.66 Liters/second
Standard Deviation 0.68
|
1.68 Liters/second
Standard Deviation 0.83
|
1.76 Liters/second
Standard Deviation 0.83
|
1.56 Liters/second
Standard Deviation 0.72
|
|
Forced Expiratory Flow 25- 75% (FEF25-75) on Day 7 and Day 8
23.16 hours post-dose
|
1.66 Liters/second
Standard Deviation 0.67
|
1.69 Liters/second
Standard Deviation 0.81
|
1.68 Liters/second
Standard Deviation 0.84
|
1.52 Liters/second
Standard Deviation 0.64
|
|
Forced Expiratory Flow 25- 75% (FEF25-75) on Day 7 and Day 8
23.75 hours post-dose
|
1.74 Liters/second
Standard Deviation 0.72
|
1.73 Liters/second
Standard Deviation 0.79
|
1.79 Liters/second
Standard Deviation 0.76
|
1.62 Liters/second
Standard Deviation 0.72
|
SECONDARY outcome
Timeframe: Day 1, Day 7Population: Pharmacodynamics Analysis set included all participants that received at least one dose of study drug and had baseline and at least one post-baseline FEV1 measurement.
Spirometry was conducted according to internationally accepted standards at predose, 5, 15 and 30 minutes, 1, 2 and 4 hours post-dose on Day 1 and Day 7. The standardized (with respect to the length of time) area under the curve (AUC) for FEV1 was calculated using trapezoidal rule between 5 min and 4 h post. Analysis of Covariance with treatment, period, sequence and subject nested within sequence as fixed effects and period FEV1 baseline as a covariate.
Outcome measures
| Measure |
75 µg Indacaterol (LB)
n=34 Participants
75 µg indacaterol lactose blend (LB) delivered via the Concept1 device once daily in the morning for 7 days.
|
75 µg Indacaterol (PoS)
n=31 Participants
75 µg indacaterol PulmoSphereTM (PoS) delivered via the Concept1 device daily in the morning for 7 days.
|
37.5 µg Indacaterol (PoS)
n=30 Participants
37.5 µg indacaterol PulmoSphereTM (PoS) delivered via the Concept1 device in the morning for 7 days.
|
Placebo
n=33 Participants
Placebo to indacterol lactose blend or PulmoSphereTM delivered via the Concept1 device in the morning for 7 days.
|
|---|---|---|---|---|
|
Standardized FEV1 AUC Between Baseline (Pre-dose) and 4 Hour Post-dose (AUC0-4h)
Day 1
|
2.94 Liters
Interval 2.9 to 2.99
|
3.00 Liters
Interval 2.95 to 3.05
|
2.94 Liters
Interval 2.89 to 2.99
|
2.72 Liters
Interval 2.68 to 2.77
|
|
Standardized FEV1 AUC Between Baseline (Pre-dose) and 4 Hour Post-dose (AUC0-4h)
Day 7 (n=33,30,32,33)
|
2.96 Liters
Interval 2.92 to 3.0
|
2.98 Liters
Interval 2.93 to 3.02
|
2.97 Liters
Interval 2.93 to 3.02
|
2.73 Liters
Interval 2.68 to 2.77
|
SECONDARY outcome
Timeframe: Day 1, Day 7Population: Pharmacodynamics Analysis set included all participants that received at least one dose of study drug and had baseline and at least one post-baseline FEV1 measurement.
Spirometry was conducted according to internationally accepted standards at predose, 5 , 15 and 30 min, 1, 2, 4, 8 and 12 hours post-dose on Day 1 and Day 7. The standardized (with respect to the length of time) area under the curve (AUC) for FEV1 was calculated using trapezoidal rule between 5 min and 12 h post. Analysis of covariance with treatment, period, sequence and subject nested within sequence as fixed effects and FEV1 period baseline as a covariate.
Outcome measures
| Measure |
75 µg Indacaterol (LB)
n=32 Participants
75 µg indacaterol lactose blend (LB) delivered via the Concept1 device once daily in the morning for 7 days.
|
75 µg Indacaterol (PoS)
n=29 Participants
75 µg indacaterol PulmoSphereTM (PoS) delivered via the Concept1 device daily in the morning for 7 days.
|
37.5 µg Indacaterol (PoS)
n=30 Participants
37.5 µg indacaterol PulmoSphereTM (PoS) delivered via the Concept1 device in the morning for 7 days.
|
Placebo
n=31 Participants
Placebo to indacterol lactose blend or PulmoSphereTM delivered via the Concept1 device in the morning for 7 days.
|
|---|---|---|---|---|
|
Standardized FEV1 AUC Between Baseline (Pre-dose) and 12 Hour Post-dose (AUC0-12h)
Day 1
|
2.90 Liters
Interval 2.85 to 2.95
|
2.94 Liters
Interval 2.89 to 2.99
|
2.87 Liters
Interval 2.82 to 2.92
|
2.68 Liters
Interval 2.63 to 2.72
|
|
Standardized FEV1 AUC Between Baseline (Pre-dose) and 12 Hour Post-dose (AUC0-12h)
Day 7 (n=31,29,30,31)
|
2.93 Liters
Interval 2.88 to 2.97
|
2.92 Liters
Interval 2.88 to 2.96
|
2.91 Liters
Interval 2.87 to 2.95
|
2.70 Liters
Interval 2.66 to 2.74
|
SECONDARY outcome
Timeframe: Up to 101 daysPopulation: Pharmacodynamics Analysis set included all participants that received at least one dose of study drug and had baseline and at least one post-baseline FEV1 measurement.
PEFR was measured on all days from Screening Visit 2 to end of study visit: twice daily pre-dose (prior to Inhaled Corticosteroids) and approximately 12 hours post-dose (during the treatment period). Each subject was provided with a PEFR meter and recorded the PEFR readings in a daily diary. repeated measures. Analysis of covariance with treatment, period, sequence, day and treatment-day interaction as fixed effect and subject as a random effect and baseline PEFR as a covariate in the model.
Outcome measures
| Measure |
75 µg Indacaterol (LB)
n=34 Participants
75 µg indacaterol lactose blend (LB) delivered via the Concept1 device once daily in the morning for 7 days.
|
75 µg Indacaterol (PoS)
n=31 Participants
75 µg indacaterol PulmoSphereTM (PoS) delivered via the Concept1 device daily in the morning for 7 days.
|
37.5 µg Indacaterol (PoS)
n=33 Participants
37.5 µg indacaterol PulmoSphereTM (PoS) delivered via the Concept1 device in the morning for 7 days.
|
Placebo
n=33 Participants
Placebo to indacterol lactose blend or PulmoSphereTM delivered via the Concept1 device in the morning for 7 days.
|
|---|---|---|---|---|
|
Peak Expiratory Flow Rate in the Morning in the Evening
Morning
|
451.33 Liters per second
Standard Error 2.35
|
447.15 Liters per second
Standard Error 2.50
|
444.11 Liters per second
Standard Error 2.47
|
421.58 Liters per second
Standard Error 2.41
|
|
Peak Expiratory Flow Rate in the Morning in the Evening
Evening
|
474.09 Liters per second
Standard Error 2.18
|
464.39 Liters per second
Standard Error 2.33
|
463.28 Liters per second
Standard Error 2.30
|
433.60 Liters per second
Standard Error 2.24
|
SECONDARY outcome
Timeframe: Up to 101 daysPopulation: Participants in the Pharmacodynamics Analysis set (included all participants that received at least one dose of study drug and had baseline and at least one post-baseline FEV1 measurement) who used rescue medication.
Salbutamol (100 µg/puff) was used as rescued medicine. The total number of puffs per day was calculated and divided by the number of days with data to determine the mean daily number of puffs of rescue medication for each patient and was recorded in the patient diary from Baseline until Day 8 of Treatment Period 4. Analysis of covariance with treatment, period, sequence, and subject nested within sequence as fixed effect.
Outcome measures
| Measure |
75 µg Indacaterol (LB)
n=13 Participants
75 µg indacaterol lactose blend (LB) delivered via the Concept1 device once daily in the morning for 7 days.
|
75 µg Indacaterol (PoS)
n=14 Participants
75 µg indacaterol PulmoSphereTM (PoS) delivered via the Concept1 device daily in the morning for 7 days.
|
37.5 µg Indacaterol (PoS)
n=8 Participants
37.5 µg indacaterol PulmoSphereTM (PoS) delivered via the Concept1 device in the morning for 7 days.
|
Placebo
n=16 Participants
Placebo to indacterol lactose blend or PulmoSphereTM delivered via the Concept1 device in the morning for 7 days.
|
|---|---|---|---|---|
|
Number of Puffs of Rescue Medicine
|
1.98 Puffs/day
Interval 1.9 to 2.06
|
1.90 Puffs/day
Interval 1.83 to 1.98
|
1.91 Puffs/day
Interval 1.82 to 2.0
|
1.94 Puffs/day
Interval 1.87 to 2.0
|
SECONDARY outcome
Timeframe: Up to 101 daysPopulation: Safety population inlcuded all participants who received at least one dose of study drug.
Adverse event are defined as any unfavorable and unintended diagnosis, symptoms, sign (including an abnormal lab finding), syndrome or disease which either occurs during the study, having been absent at baseline, or if present at baseline appear to worsen. Serious adverse events are any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization , cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgments of the investigators represent significant hazards. Additional information about adverse events can be found in the Adverse Event section
Outcome measures
| Measure |
75 µg Indacaterol (LB)
n=34 Participants
75 µg indacaterol lactose blend (LB) delivered via the Concept1 device once daily in the morning for 7 days.
|
75 µg Indacaterol (PoS)
n=31 Participants
75 µg indacaterol PulmoSphereTM (PoS) delivered via the Concept1 device daily in the morning for 7 days.
|
37.5 µg Indacaterol (PoS)
n=33 Participants
37.5 µg indacaterol PulmoSphereTM (PoS) delivered via the Concept1 device in the morning for 7 days.
|
Placebo
n=33 Participants
Placebo to indacterol lactose blend or PulmoSphereTM delivered via the Concept1 device in the morning for 7 days.
|
|---|---|---|---|---|
|
Number of Participants With Adverse Events as a Measure of Safety
|
14 Participants
|
16 Participants
|
17 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: Day1, Day 7Population: PK Analysis Set
Outcome measures
| Measure |
75 µg Indacaterol (LB)
n=34 Participants
75 µg indacaterol lactose blend (LB) delivered via the Concept1 device once daily in the morning for 7 days.
|
75 µg Indacaterol (PoS)
n=31 Participants
75 µg indacaterol PulmoSphereTM (PoS) delivered via the Concept1 device daily in the morning for 7 days.
|
37.5 µg Indacaterol (PoS)
n=33 Participants
37.5 µg indacaterol PulmoSphereTM (PoS) delivered via the Concept1 device in the morning for 7 days.
|
Placebo
Placebo to indacterol lactose blend or PulmoSphereTM delivered via the Concept1 device in the morning for 7 days.
|
|---|---|---|---|---|
|
Time to Reach Maximum Concentration (Tmax) After Drug Administration
Day 1 (n=31,30,31)
|
0.27 Hours
Interval 0.22 to 1.03
|
0.48 Hours
Interval 0.2 to 0.58
|
0.48 Hours
Interval 0.2 to 1.0
|
—
|
|
Time to Reach Maximum Concentration (Tmax) After Drug Administration
Day 7 (n=33,31,31)
|
0.25 Hours
Interval 0.08 to 0.75
|
0.48 Hours
Interval 0.22 to 0.98
|
0.25 Hours
Interval 0.22 to 1.02
|
—
|
SECONDARY outcome
Timeframe: Day 1, Day 7Population: PK Analysis Set
Outcome measures
| Measure |
75 µg Indacaterol (LB)
n=34 Participants
75 µg indacaterol lactose blend (LB) delivered via the Concept1 device once daily in the morning for 7 days.
|
75 µg Indacaterol (PoS)
n=31 Participants
75 µg indacaterol PulmoSphereTM (PoS) delivered via the Concept1 device daily in the morning for 7 days.
|
37.5 µg Indacaterol (PoS)
n=33 Participants
37.5 µg indacaterol PulmoSphereTM (PoS) delivered via the Concept1 device in the morning for 7 days.
|
Placebo
Placebo to indacterol lactose blend or PulmoSphereTM delivered via the Concept1 device in the morning for 7 days.
|
|---|---|---|---|---|
|
Observed Maximum Concentration (Cmax) After Drug Administration
Day 1 (n=31,30,31)
|
72.9 pg/mL
Standard Deviation 25.7
|
124 pg/mL
Standard Deviation 55.7
|
64.2 pg/mL
Standard Deviation 27.9
|
—
|
|
Observed Maximum Concentration (Cmax) After Drug Administration
Day 7 (n=33,31,31)
|
112 pg/mL
Standard Deviation 27.1
|
174 pg/mL
Standard Deviation 61.4
|
90.5 pg/mL
Standard Deviation 23.9
|
—
|
SECONDARY outcome
Timeframe: Day 1, Day 7Population: PK Analysis Set
Outcome measures
| Measure |
75 µg Indacaterol (LB)
n=34 Participants
75 µg indacaterol lactose blend (LB) delivered via the Concept1 device once daily in the morning for 7 days.
|
75 µg Indacaterol (PoS)
n=31 Participants
75 µg indacaterol PulmoSphereTM (PoS) delivered via the Concept1 device daily in the morning for 7 days.
|
37.5 µg Indacaterol (PoS)
n=33 Participants
37.5 µg indacaterol PulmoSphereTM (PoS) delivered via the Concept1 device in the morning for 7 days.
|
Placebo
Placebo to indacterol lactose blend or PulmoSphereTM delivered via the Concept1 device in the morning for 7 days.
|
|---|---|---|---|---|
|
Area Under the Curve Pre-dose to 24 Hour Post Dose (AUC0-24h)
Day 1 (n=30,30,27)
|
501 hour*pg/mL
Standard Deviation 149
|
802 hour*pg/mL
Standard Deviation 308
|
451 hour*pg/mL
Standard Deviation 134
|
—
|
|
Area Under the Curve Pre-dose to 24 Hour Post Dose (AUC0-24h)
Day 7 (n=33,31,31)
|
1110 hour*pg/mL
Standard Deviation 273
|
1770 hour*pg/mL
Standard Deviation 522
|
952 hour*pg/mL
Standard Deviation 287
|
—
|
Adverse Events
75 µg Indacaterol (LB)
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
75 µg Indacaterol (PoS)
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
37.5 µg Indacaterol (PoS)
Serious events: 0 serious events
Other events: 17 other events
Deaths: 0 deaths
Placebo
Serious events: 1 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
75 µg Indacaterol (LB)
n=34 participants at risk
75 µg indacaterol lactose blend (LB) delivered via the Concept1 device once daily in the morning for 7 days.
|
75 µg Indacaterol (PoS)
n=31 participants at risk
75 µg indacaterol PulmoSphereTM (PoS) delivered via the Concept1 device daily in the morning for 7 days.
|
37.5 µg Indacaterol (PoS)
n=33 participants at risk
37.5 µg indacaterol PulmoSphereTM (PoS) delivered via the Concept1 device in the morning for 7 days.
|
Placebo
n=33 participants at risk
Placebo to indacterol lactose blend or PulmoSphereTM delivered via the Concept1 device in the morning for 7 days.
|
|---|---|---|---|---|
|
Injury, poisoning and procedural complications
Ligament rupture
|
0.00%
0/34
The number of participants at risk for serious adverse events and non-serious adverse events is based on those participants in the arm who received at least one dose of study drug.
|
0.00%
0/31
The number of participants at risk for serious adverse events and non-serious adverse events is based on those participants in the arm who received at least one dose of study drug.
|
0.00%
0/33
The number of participants at risk for serious adverse events and non-serious adverse events is based on those participants in the arm who received at least one dose of study drug.
|
3.0%
1/33
The number of participants at risk for serious adverse events and non-serious adverse events is based on those participants in the arm who received at least one dose of study drug.
|
Other adverse events
| Measure |
75 µg Indacaterol (LB)
n=34 participants at risk
75 µg indacaterol lactose blend (LB) delivered via the Concept1 device once daily in the morning for 7 days.
|
75 µg Indacaterol (PoS)
n=31 participants at risk
75 µg indacaterol PulmoSphereTM (PoS) delivered via the Concept1 device daily in the morning for 7 days.
|
37.5 µg Indacaterol (PoS)
n=33 participants at risk
37.5 µg indacaterol PulmoSphereTM (PoS) delivered via the Concept1 device in the morning for 7 days.
|
Placebo
n=33 participants at risk
Placebo to indacterol lactose blend or PulmoSphereTM delivered via the Concept1 device in the morning for 7 days.
|
|---|---|---|---|---|
|
Eye disorders
Conjunctivitis
|
0.00%
0/34
The number of participants at risk for serious adverse events and non-serious adverse events is based on those participants in the arm who received at least one dose of study drug.
|
0.00%
0/31
The number of participants at risk for serious adverse events and non-serious adverse events is based on those participants in the arm who received at least one dose of study drug.
|
0.00%
0/33
The number of participants at risk for serious adverse events and non-serious adverse events is based on those participants in the arm who received at least one dose of study drug.
|
3.0%
1/33
The number of participants at risk for serious adverse events and non-serious adverse events is based on those participants in the arm who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain
|
2.9%
1/34
The number of participants at risk for serious adverse events and non-serious adverse events is based on those participants in the arm who received at least one dose of study drug.
|
0.00%
0/31
The number of participants at risk for serious adverse events and non-serious adverse events is based on those participants in the arm who received at least one dose of study drug.
|
0.00%
0/33
The number of participants at risk for serious adverse events and non-serious adverse events is based on those participants in the arm who received at least one dose of study drug.
|
0.00%
0/33
The number of participants at risk for serious adverse events and non-serious adverse events is based on those participants in the arm who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
2.9%
1/34
The number of participants at risk for serious adverse events and non-serious adverse events is based on those participants in the arm who received at least one dose of study drug.
|
0.00%
0/31
The number of participants at risk for serious adverse events and non-serious adverse events is based on those participants in the arm who received at least one dose of study drug.
|
3.0%
1/33
The number of participants at risk for serious adverse events and non-serious adverse events is based on those participants in the arm who received at least one dose of study drug.
|
0.00%
0/33
The number of participants at risk for serious adverse events and non-serious adverse events is based on those participants in the arm who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Dyspepsia
|
2.9%
1/34
The number of participants at risk for serious adverse events and non-serious adverse events is based on those participants in the arm who received at least one dose of study drug.
|
0.00%
0/31
The number of participants at risk for serious adverse events and non-serious adverse events is based on those participants in the arm who received at least one dose of study drug.
|
0.00%
0/33
The number of participants at risk for serious adverse events and non-serious adverse events is based on those participants in the arm who received at least one dose of study drug.
|
0.00%
0/33
The number of participants at risk for serious adverse events and non-serious adverse events is based on those participants in the arm who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
2.9%
1/34
The number of participants at risk for serious adverse events and non-serious adverse events is based on those participants in the arm who received at least one dose of study drug.
|
3.2%
1/31
The number of participants at risk for serious adverse events and non-serious adverse events is based on those participants in the arm who received at least one dose of study drug.
|
0.00%
0/33
The number of participants at risk for serious adverse events and non-serious adverse events is based on those participants in the arm who received at least one dose of study drug.
|
3.0%
1/33
The number of participants at risk for serious adverse events and non-serious adverse events is based on those participants in the arm who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Toothache
|
2.9%
1/34
The number of participants at risk for serious adverse events and non-serious adverse events is based on those participants in the arm who received at least one dose of study drug.
|
0.00%
0/31
The number of participants at risk for serious adverse events and non-serious adverse events is based on those participants in the arm who received at least one dose of study drug.
|
0.00%
0/33
The number of participants at risk for serious adverse events and non-serious adverse events is based on those participants in the arm who received at least one dose of study drug.
|
0.00%
0/33
The number of participants at risk for serious adverse events and non-serious adverse events is based on those participants in the arm who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Vomiting
|
5.9%
2/34
The number of participants at risk for serious adverse events and non-serious adverse events is based on those participants in the arm who received at least one dose of study drug.
|
0.00%
0/31
The number of participants at risk for serious adverse events and non-serious adverse events is based on those participants in the arm who received at least one dose of study drug.
|
0.00%
0/33
The number of participants at risk for serious adverse events and non-serious adverse events is based on those participants in the arm who received at least one dose of study drug.
|
3.0%
1/33
The number of participants at risk for serious adverse events and non-serious adverse events is based on those participants in the arm who received at least one dose of study drug.
|
|
General disorders
Fatigue
|
0.00%
0/34
The number of participants at risk for serious adverse events and non-serious adverse events is based on those participants in the arm who received at least one dose of study drug.
|
0.00%
0/31
The number of participants at risk for serious adverse events and non-serious adverse events is based on those participants in the arm who received at least one dose of study drug.
|
3.0%
1/33
The number of participants at risk for serious adverse events and non-serious adverse events is based on those participants in the arm who received at least one dose of study drug.
|
0.00%
0/33
The number of participants at risk for serious adverse events and non-serious adverse events is based on those participants in the arm who received at least one dose of study drug.
|
|
General disorders
Product taste abnormal
|
0.00%
0/34
The number of participants at risk for serious adverse events and non-serious adverse events is based on those participants in the arm who received at least one dose of study drug.
|
0.00%
0/31
The number of participants at risk for serious adverse events and non-serious adverse events is based on those participants in the arm who received at least one dose of study drug.
|
6.1%
2/33
The number of participants at risk for serious adverse events and non-serious adverse events is based on those participants in the arm who received at least one dose of study drug.
|
0.00%
0/33
The number of participants at risk for serious adverse events and non-serious adverse events is based on those participants in the arm who received at least one dose of study drug.
|
|
Infections and infestations
Gastritis viral
|
2.9%
1/34
The number of participants at risk for serious adverse events and non-serious adverse events is based on those participants in the arm who received at least one dose of study drug.
|
0.00%
0/31
The number of participants at risk for serious adverse events and non-serious adverse events is based on those participants in the arm who received at least one dose of study drug.
|
0.00%
0/33
The number of participants at risk for serious adverse events and non-serious adverse events is based on those participants in the arm who received at least one dose of study drug.
|
0.00%
0/33
The number of participants at risk for serious adverse events and non-serious adverse events is based on those participants in the arm who received at least one dose of study drug.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/34
The number of participants at risk for serious adverse events and non-serious adverse events is based on those participants in the arm who received at least one dose of study drug.
|
6.5%
2/31
The number of participants at risk for serious adverse events and non-serious adverse events is based on those participants in the arm who received at least one dose of study drug.
|
3.0%
1/33
The number of participants at risk for serious adverse events and non-serious adverse events is based on those participants in the arm who received at least one dose of study drug.
|
0.00%
0/33
The number of participants at risk for serious adverse events and non-serious adverse events is based on those participants in the arm who received at least one dose of study drug.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/34
The number of participants at risk for serious adverse events and non-serious adverse events is based on those participants in the arm who received at least one dose of study drug.
|
3.2%
1/31
The number of participants at risk for serious adverse events and non-serious adverse events is based on those participants in the arm who received at least one dose of study drug.
|
0.00%
0/33
The number of participants at risk for serious adverse events and non-serious adverse events is based on those participants in the arm who received at least one dose of study drug.
|
0.00%
0/33
The number of participants at risk for serious adverse events and non-serious adverse events is based on those participants in the arm who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Excoriation
|
0.00%
0/34
The number of participants at risk for serious adverse events and non-serious adverse events is based on those participants in the arm who received at least one dose of study drug.
|
0.00%
0/31
The number of participants at risk for serious adverse events and non-serious adverse events is based on those participants in the arm who received at least one dose of study drug.
|
0.00%
0/33
The number of participants at risk for serious adverse events and non-serious adverse events is based on those participants in the arm who received at least one dose of study drug.
|
3.0%
1/33
The number of participants at risk for serious adverse events and non-serious adverse events is based on those participants in the arm who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Fall
|
2.9%
1/34
The number of participants at risk for serious adverse events and non-serious adverse events is based on those participants in the arm who received at least one dose of study drug.
|
0.00%
0/31
The number of participants at risk for serious adverse events and non-serious adverse events is based on those participants in the arm who received at least one dose of study drug.
|
0.00%
0/33
The number of participants at risk for serious adverse events and non-serious adverse events is based on those participants in the arm who received at least one dose of study drug.
|
0.00%
0/33
The number of participants at risk for serious adverse events and non-serious adverse events is based on those participants in the arm who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Joint injury
|
2.9%
1/34
The number of participants at risk for serious adverse events and non-serious adverse events is based on those participants in the arm who received at least one dose of study drug.
|
0.00%
0/31
The number of participants at risk for serious adverse events and non-serious adverse events is based on those participants in the arm who received at least one dose of study drug.
|
0.00%
0/33
The number of participants at risk for serious adverse events and non-serious adverse events is based on those participants in the arm who received at least one dose of study drug.
|
0.00%
0/33
The number of participants at risk for serious adverse events and non-serious adverse events is based on those participants in the arm who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Laceration
|
0.00%
0/34
The number of participants at risk for serious adverse events and non-serious adverse events is based on those participants in the arm who received at least one dose of study drug.
|
0.00%
0/31
The number of participants at risk for serious adverse events and non-serious adverse events is based on those participants in the arm who received at least one dose of study drug.
|
3.0%
1/33
The number of participants at risk for serious adverse events and non-serious adverse events is based on those participants in the arm who received at least one dose of study drug.
|
0.00%
0/33
The number of participants at risk for serious adverse events and non-serious adverse events is based on those participants in the arm who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Muscle rupture
|
2.9%
1/34
The number of participants at risk for serious adverse events and non-serious adverse events is based on those participants in the arm who received at least one dose of study drug.
|
0.00%
0/31
The number of participants at risk for serious adverse events and non-serious adverse events is based on those participants in the arm who received at least one dose of study drug.
|
0.00%
0/33
The number of participants at risk for serious adverse events and non-serious adverse events is based on those participants in the arm who received at least one dose of study drug.
|
0.00%
0/33
The number of participants at risk for serious adverse events and non-serious adverse events is based on those participants in the arm who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Soft tissue injury
|
2.9%
1/34
The number of participants at risk for serious adverse events and non-serious adverse events is based on those participants in the arm who received at least one dose of study drug.
|
0.00%
0/31
The number of participants at risk for serious adverse events and non-serious adverse events is based on those participants in the arm who received at least one dose of study drug.
|
0.00%
0/33
The number of participants at risk for serious adverse events and non-serious adverse events is based on those participants in the arm who received at least one dose of study drug.
|
0.00%
0/33
The number of participants at risk for serious adverse events and non-serious adverse events is based on those participants in the arm who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Sunburn
|
2.9%
1/34
The number of participants at risk for serious adverse events and non-serious adverse events is based on those participants in the arm who received at least one dose of study drug.
|
0.00%
0/31
The number of participants at risk for serious adverse events and non-serious adverse events is based on those participants in the arm who received at least one dose of study drug.
|
0.00%
0/33
The number of participants at risk for serious adverse events and non-serious adverse events is based on those participants in the arm who received at least one dose of study drug.
|
0.00%
0/33
The number of participants at risk for serious adverse events and non-serious adverse events is based on those participants in the arm who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
2.9%
1/34
The number of participants at risk for serious adverse events and non-serious adverse events is based on those participants in the arm who received at least one dose of study drug.
|
0.00%
0/31
The number of participants at risk for serious adverse events and non-serious adverse events is based on those participants in the arm who received at least one dose of study drug.
|
0.00%
0/33
The number of participants at risk for serious adverse events and non-serious adverse events is based on those participants in the arm who received at least one dose of study drug.
|
0.00%
0/33
The number of participants at risk for serious adverse events and non-serious adverse events is based on those participants in the arm who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
2.9%
1/34
The number of participants at risk for serious adverse events and non-serious adverse events is based on those participants in the arm who received at least one dose of study drug.
|
0.00%
0/31
The number of participants at risk for serious adverse events and non-serious adverse events is based on those participants in the arm who received at least one dose of study drug.
|
0.00%
0/33
The number of participants at risk for serious adverse events and non-serious adverse events is based on those participants in the arm who received at least one dose of study drug.
|
0.00%
0/33
The number of participants at risk for serious adverse events and non-serious adverse events is based on those participants in the arm who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/34
The number of participants at risk for serious adverse events and non-serious adverse events is based on those participants in the arm who received at least one dose of study drug.
|
3.2%
1/31
The number of participants at risk for serious adverse events and non-serious adverse events is based on those participants in the arm who received at least one dose of study drug.
|
0.00%
0/33
The number of participants at risk for serious adverse events and non-serious adverse events is based on those participants in the arm who received at least one dose of study drug.
|
0.00%
0/33
The number of participants at risk for serious adverse events and non-serious adverse events is based on those participants in the arm who received at least one dose of study drug.
|
|
Nervous system disorders
Headache
|
14.7%
5/34
The number of participants at risk for serious adverse events and non-serious adverse events is based on those participants in the arm who received at least one dose of study drug.
|
12.9%
4/31
The number of participants at risk for serious adverse events and non-serious adverse events is based on those participants in the arm who received at least one dose of study drug.
|
15.2%
5/33
The number of participants at risk for serious adverse events and non-serious adverse events is based on those participants in the arm who received at least one dose of study drug.
|
15.2%
5/33
The number of participants at risk for serious adverse events and non-serious adverse events is based on those participants in the arm who received at least one dose of study drug.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/34
The number of participants at risk for serious adverse events and non-serious adverse events is based on those participants in the arm who received at least one dose of study drug.
|
3.2%
1/31
The number of participants at risk for serious adverse events and non-serious adverse events is based on those participants in the arm who received at least one dose of study drug.
|
0.00%
0/33
The number of participants at risk for serious adverse events and non-serious adverse events is based on those participants in the arm who received at least one dose of study drug.
|
0.00%
0/33
The number of participants at risk for serious adverse events and non-serious adverse events is based on those participants in the arm who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
2.9%
1/34
The number of participants at risk for serious adverse events and non-serious adverse events is based on those participants in the arm who received at least one dose of study drug.
|
3.2%
1/31
The number of participants at risk for serious adverse events and non-serious adverse events is based on those participants in the arm who received at least one dose of study drug.
|
0.00%
0/33
The number of participants at risk for serious adverse events and non-serious adverse events is based on those participants in the arm who received at least one dose of study drug.
|
0.00%
0/33
The number of participants at risk for serious adverse events and non-serious adverse events is based on those participants in the arm who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.9%
2/34
The number of participants at risk for serious adverse events and non-serious adverse events is based on those participants in the arm who received at least one dose of study drug.
|
38.7%
12/31
The number of participants at risk for serious adverse events and non-serious adverse events is based on those participants in the arm who received at least one dose of study drug.
|
24.2%
8/33
The number of participants at risk for serious adverse events and non-serious adverse events is based on those participants in the arm who received at least one dose of study drug.
|
0.00%
0/33
The number of participants at risk for serious adverse events and non-serious adverse events is based on those participants in the arm who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dry throat
|
0.00%
0/34
The number of participants at risk for serious adverse events and non-serious adverse events is based on those participants in the arm who received at least one dose of study drug.
|
3.2%
1/31
The number of participants at risk for serious adverse events and non-serious adverse events is based on those participants in the arm who received at least one dose of study drug.
|
3.0%
1/33
The number of participants at risk for serious adverse events and non-serious adverse events is based on those participants in the arm who received at least one dose of study drug.
|
0.00%
0/33
The number of participants at risk for serious adverse events and non-serious adverse events is based on those participants in the arm who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
2.9%
1/34
The number of participants at risk for serious adverse events and non-serious adverse events is based on those participants in the arm who received at least one dose of study drug.
|
0.00%
0/31
The number of participants at risk for serious adverse events and non-serious adverse events is based on those participants in the arm who received at least one dose of study drug.
|
3.0%
1/33
The number of participants at risk for serious adverse events and non-serious adverse events is based on those participants in the arm who received at least one dose of study drug.
|
0.00%
0/33
The number of participants at risk for serious adverse events and non-serious adverse events is based on those participants in the arm who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Increased upper airway secretion
|
2.9%
1/34
The number of participants at risk for serious adverse events and non-serious adverse events is based on those participants in the arm who received at least one dose of study drug.
|
0.00%
0/31
The number of participants at risk for serious adverse events and non-serious adverse events is based on those participants in the arm who received at least one dose of study drug.
|
6.1%
2/33
The number of participants at risk for serious adverse events and non-serious adverse events is based on those participants in the arm who received at least one dose of study drug.
|
0.00%
0/33
The number of participants at risk for serious adverse events and non-serious adverse events is based on those participants in the arm who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/34
The number of participants at risk for serious adverse events and non-serious adverse events is based on those participants in the arm who received at least one dose of study drug.
|
0.00%
0/31
The number of participants at risk for serious adverse events and non-serious adverse events is based on those participants in the arm who received at least one dose of study drug.
|
3.0%
1/33
The number of participants at risk for serious adverse events and non-serious adverse events is based on those participants in the arm who received at least one dose of study drug.
|
0.00%
0/33
The number of participants at risk for serious adverse events and non-serious adverse events is based on those participants in the arm who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
2.9%
1/34
The number of participants at risk for serious adverse events and non-serious adverse events is based on those participants in the arm who received at least one dose of study drug.
|
6.5%
2/31
The number of participants at risk for serious adverse events and non-serious adverse events is based on those participants in the arm who received at least one dose of study drug.
|
3.0%
1/33
The number of participants at risk for serious adverse events and non-serious adverse events is based on those participants in the arm who received at least one dose of study drug.
|
3.0%
1/33
The number of participants at risk for serious adverse events and non-serious adverse events is based on those participants in the arm who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
2.9%
1/34
The number of participants at risk for serious adverse events and non-serious adverse events is based on those participants in the arm who received at least one dose of study drug.
|
0.00%
0/31
The number of participants at risk for serious adverse events and non-serious adverse events is based on those participants in the arm who received at least one dose of study drug.
|
0.00%
0/33
The number of participants at risk for serious adverse events and non-serious adverse events is based on those participants in the arm who received at least one dose of study drug.
|
3.0%
1/33
The number of participants at risk for serious adverse events and non-serious adverse events is based on those participants in the arm who received at least one dose of study drug.
|
Additional Information
Study Director
Novartis Pharmaceuticals
Phone: 862-778-8300
Results disclosure agreements
- Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.
- Publication restrictions are in place
Restriction type: OTHER