Trial Outcomes & Findings for Single Dose Study to Assess Efficacy and Safety of 4 Doses of LAS100977 in Chronic Obstructive Pulmonary Disease (COPD) Population (NCT NCT01425814)
NCT ID: NCT01425814
Last Updated: 2017-04-10
Results Overview
Baseline was the average of the two values measured just prior to the administration of the dose of investigational medicinal product at Day 1 of each visit (time points -45 min and -15 min) Trough at Day 2 was computed as the average of the two values measured at 23 and 24 hours after administration of the morning dose of investigational medicinal product on Day 1 At each time point, three technically adequate lung function measurements were performed by spirometry according to the acceptability and repeatability criteria of the ATS/ERS; the highest values for the FEV1 and FVC were selected
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
87 participants
Primary outcome timeframe
Day 2
Results posted on
2017-04-10
Participant Flow
The study was conducted in 9 sites in Germany, 8 of which randomized patients
Screening took place 14±2 days before randomization. After screening, eligible patients entered a run-in period to assess clinical stability. A total of 87 patients were screened, of whom 70 patients were assessed as eligible and randomized; 17 were not randomized due to screening failure (primarily non-fulfillment of inclusion/exclusion criteria)
Participant milestones
| Measure |
Sequence A
Indacaterol 150 μg - LAS100977 10 μg - Placebo - LAS100977 0.625 μg - LAS100977 5 μg- LAS100977 2.5 μg
|
Sequence B
LAS100977 10 μg - LAS100977 0.625 μg - Indacaterol 150 μg - LAS100977 2.5 μg - Placebo - LAS100977 5 μg
|
Sequence C
LAS100977 0.625 μg - LAS100977 2.5 μg - LAS100977 10 μg - LAS100977 5 μg - Indacaterol 150 μg - Placebo
|
Sequence D
LAS100977 2.5 μg - LAS100977 5 μg - LAS100977 0.625 μg - Placebo - LAS100977 10 μg - Indacaterol 150 μg
|
Sequence E
LAS100977 5 μg - Placebo - LAS100977 2.5 μg - Indacaterol 150 μg - LAS100977 0.625 μg - LAS100977 10 μg
|
Sequence F
Placebo - Indacaterol 150 μg - LAS100977 5 μg - LAS100977 10 μg - LAS100977 2.5 μg - LAS100977 0.625 μg
|
|---|---|---|---|---|---|---|
|
Period 1
STARTED
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12
|
11
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12
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10
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12
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13
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Period 1
COMPLETED
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12
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10
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12
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10
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12
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13
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Period 1
NOT COMPLETED
|
0
|
1
|
0
|
0
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0
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0
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|
Period 2
STARTED
|
12
|
10
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12
|
10
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12
|
13
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Period 2
COMPLETED
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12
|
9
|
12
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10
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12
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13
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Period 2
NOT COMPLETED
|
0
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1
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0
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0
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0
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0
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|
Period 3
STARTED
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12
|
9
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12
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10
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12
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13
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Period 3
COMPLETED
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12
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9
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12
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10
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12
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12
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Period 3
NOT COMPLETED
|
0
|
0
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0
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0
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0
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1
|
|
Period 4
STARTED
|
12
|
9
|
12
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10
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12
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12
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Period 4
COMPLETED
|
11
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9
|
11
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10
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12
|
12
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Period 4
NOT COMPLETED
|
1
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0
|
1
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0
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0
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0
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|
Period 5
STARTED
|
11
|
9
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11
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10
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12
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12
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Period 5
COMPLETED
|
11
|
9
|
10
|
10
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12
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11
|
|
Period 5
NOT COMPLETED
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0
|
0
|
1
|
0
|
0
|
1
|
Reasons for withdrawal
| Measure |
Sequence A
Indacaterol 150 μg - LAS100977 10 μg - Placebo - LAS100977 0.625 μg - LAS100977 5 μg- LAS100977 2.5 μg
|
Sequence B
LAS100977 10 μg - LAS100977 0.625 μg - Indacaterol 150 μg - LAS100977 2.5 μg - Placebo - LAS100977 5 μg
|
Sequence C
LAS100977 0.625 μg - LAS100977 2.5 μg - LAS100977 10 μg - LAS100977 5 μg - Indacaterol 150 μg - Placebo
|
Sequence D
LAS100977 2.5 μg - LAS100977 5 μg - LAS100977 0.625 μg - Placebo - LAS100977 10 μg - Indacaterol 150 μg
|
Sequence E
LAS100977 5 μg - Placebo - LAS100977 2.5 μg - Indacaterol 150 μg - LAS100977 0.625 μg - LAS100977 10 μg
|
Sequence F
Placebo - Indacaterol 150 μg - LAS100977 5 μg - LAS100977 10 μg - LAS100977 2.5 μg - LAS100977 0.625 μg
|
|---|---|---|---|---|---|---|
|
Period 1
Stability criteria not fulfilled
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Period 2
Stability criteria not fulfilled
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Period 3
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Period 4
Adverse Event
|
1
|
0
|
1
|
0
|
0
|
0
|
|
Period 5
Stability criteria not fulfilled
|
0
|
0
|
1
|
0
|
0
|
1
|
Baseline Characteristics
Single Dose Study to Assess Efficacy and Safety of 4 Doses of LAS100977 in Chronic Obstructive Pulmonary Disease (COPD) Population
Baseline characteristics by cohort
| Measure |
Overall Population
n=70 Participants
All patients who were randomized and received at least one dose of investigational medicinal product
|
|---|---|
|
Age, Continuous
|
61.2 Years
STANDARD_DEVIATION 7.7 • n=99 Participants
|
|
Sex: Female, Male
Female
|
26 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
44 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Day 2Population: ITT population defined as patients who took at least one dose of investigational medicinal product and had at least a baseline and one post-dose value of FEV1 from at least one treatment period
Baseline was the average of the two values measured just prior to the administration of the dose of investigational medicinal product at Day 1 of each visit (time points -45 min and -15 min) Trough at Day 2 was computed as the average of the two values measured at 23 and 24 hours after administration of the morning dose of investigational medicinal product on Day 1 At each time point, three technically adequate lung function measurements were performed by spirometry according to the acceptability and repeatability criteria of the ATS/ERS; the highest values for the FEV1 and FVC were selected
Outcome measures
| Measure |
Placebo
n=68 Participants
Single dose administered by inhalation from the Genuair® device and the Breezhaler® inhaler
|
LAS100977 0.625 μg
n=67 Participants
Single dose administered by inhalation from the Genuair® device
|
LAS100977 2.5 μg
n=66 Participants
Single dose administered by inhalation from the Genuair® device
|
LAS100977 5 μg
n=66 Participants
Single dose administered by inhalation from the Genuair® device
|
LAS100977 10 μg
n=67 Participants
Single dose administered by inhalation from the Genuair® device
|
Indacaterol 150 μg
n=68 Participants
Single dose administered by inhalation from the Breezhaler® inhaler
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Trough Forced Expiratory Volume in One Second (FEV1)
|
-0.035 Liters
Standard Error 0.024
|
0.066 Liters
Standard Error 0.024
|
0.168 Liters
Standard Error 0.024
|
0.198 Liters
Standard Error 0.024
|
0.223 Liters
Standard Error 0.024
|
0.076 Liters
Standard Error 0.024
|
SECONDARY outcome
Timeframe: Day 1Population: ITT population defined as patients who took at least one dose of investigational medicinal product and had at least a baseline and one post-dose value of FEV1 from at least one treatment period
Baseline was the average of the two values measured just prior to the administration of the dose of investigational medicinal product at Day 1 of each visit (time points -45 min and -15 min) At each time point, three technically adequate lung function measurements were performed by spirometry according to the acceptability and repeatability criteria of the ATS/ERS; the highest values for the FEV1 and FVC were selected
Outcome measures
| Measure |
Placebo
n=68 Participants
Single dose administered by inhalation from the Genuair® device and the Breezhaler® inhaler
|
LAS100977 0.625 μg
n=67 Participants
Single dose administered by inhalation from the Genuair® device
|
LAS100977 2.5 μg
n=66 Participants
Single dose administered by inhalation from the Genuair® device
|
LAS100977 5 μg
n=66 Participants
Single dose administered by inhalation from the Genuair® device
|
LAS100977 10 μg
n=67 Participants
Single dose administered by inhalation from the Genuair® device
|
Indacaterol 150 μg
n=68 Participants
Single dose administered by inhalation from the Breezhaler® inhaler
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Normalised Forced Expiratory Volume in One Second (FEV1) Area Under the Curve
Change from baseline in FEV1 AUC0-12
|
-0.003 Liters
Standard Error 0.012
|
0.168 Liters
Standard Error 0.021
|
0.243 Liters
Standard Error 0.021
|
0.247 Liters
Standard Error 0.021
|
0.288 Liters
Standard Error 0.022
|
0.134 Liters
Standard Error 0.017
|
|
Change From Baseline in Normalised Forced Expiratory Volume in One Second (FEV1) Area Under the Curve
Change from baseline in FEV1 AUC0-24
|
-0.032 Liters
Standard Error 0.013
|
0.121 Liters
Standard Error 0.021
|
0.205 Liters
Standard Error 0.022
|
0.222 Liters
Standard Error 0.021
|
0.262 Liters
Standard Error 0.024
|
0.104 Liters
Standard Error 0.018
|
|
Change From Baseline in Normalised Forced Expiratory Volume in One Second (FEV1) Area Under the Curve
Change from baseline in FEV1 AUC12-24
|
-0.062 Liters
Standard Error 0.016
|
0.077 Liters
Standard Error 0.023
|
0.166 Liters
Standard Error 0.024
|
0.196 Liters
Standard Error 0.021
|
0.235 Liters
Standard Error 0.021
|
0.073 Liters
Standard Error 0.021
|
SECONDARY outcome
Timeframe: Up to Day 2Population: ITT population defined as patients who took at least one dose of investigational medicinal product and had at least a baseline and one post-dose value of FEV1 from at least one treatment period
Baseline was the average of the two values measured just prior to the administration of the dose of investigational medicinal product at Day 1 of each visit (time points -45 min and -15 min) At each time point, three technically adequate lung function measurements were performed by spirometry according to the acceptability and repeatability criteria of the ATS/ERS; the highest values for the FEV1 and FVC were selected
Outcome measures
| Measure |
Placebo
n=68 Participants
Single dose administered by inhalation from the Genuair® device and the Breezhaler® inhaler
|
LAS100977 0.625 μg
n=67 Participants
Single dose administered by inhalation from the Genuair® device
|
LAS100977 2.5 μg
n=66 Participants
Single dose administered by inhalation from the Genuair® device
|
LAS100977 5 μg
n=66 Participants
Single dose administered by inhalation from the Genuair® device
|
LAS100977 10 μg
n=67 Participants
Single dose administered by inhalation from the Genuair® device
|
Indacaterol 150 μg
n=68 Participants
Single dose administered by inhalation from the Breezhaler® inhaler
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Forced Expiratory Volume in One Second (FEV1)
Day 1 1 hr
|
0.010 Liters
Standard Error 0.015
|
0.151 Liters
Standard Error 0.020
|
0.217 Liters
Standard Error 0.021
|
0.218 Liters
Standard Error 0.018
|
0.240 Liters
Standard Error 0.023
|
0.156 Liters
Standard Error 0.016
|
|
Change From Baseline in Forced Expiratory Volume in One Second (FEV1)
Day 2 24 hr
|
-0.018 Liters
Standard Error 0.019
|
0.093 Liters
Standard Error 0.023
|
0.184 Liters
Standard Error 0.025
|
0.205 Liters
Standard Error 0.021
|
0.236 Liters
Standard Error 0.027
|
0.088 Liters
Standard Error 0.020
|
|
Change From Baseline in Forced Expiratory Volume in One Second (FEV1)
Baseline
|
1.475 Liters
Standard Error 0.059
|
1.506 Liters
Standard Error 0.065
|
1.472 Liters
Standard Error 0.062
|
1.483 Liters
Standard Error 0.063
|
1.493 Liters
Standard Error 0.065
|
1.488 Liters
Standard Error 0.064
|
|
Change From Baseline in Forced Expiratory Volume in One Second (FEV1)
Day 1 0.08 hr
|
-0.005 Liters
Standard Error 0.013
|
0.044 Liters
Standard Error 0.011
|
0.090 Liters
Standard Error 0.011
|
0.085 Liters
Standard Error 0.012
|
0.117 Liters
Standard Error 0.016
|
0.103 Liters
Standard Error 0.014
|
|
Change From Baseline in Forced Expiratory Volume in One Second (FEV1)
Day 1 0.25 hr
|
0.006 Liters
Standard Error 0.013
|
0.087 Liters
Standard Error 0.016
|
0.155 Liters
Standard Error 0.015
|
0.161 Liters
Standard Error 0.015
|
0.191 Liters
Standard Error 0.019
|
0.132 Liters
Standard Error 0.016
|
|
Change From Baseline in Forced Expiratory Volume in One Second (FEV1)
Day 1 0.5 hr
|
0.018 Liters
Standard Error 0.015
|
0.126 Liters
Standard Error 0.019
|
0.186 Liters
Standard Error 0.018
|
0.202 Liters
Standard Error 0.019
|
0.217 Liters
Standard Error 0.021
|
0.150 Liters
Standard Error 0.017
|
|
Change From Baseline in Forced Expiratory Volume in One Second (FEV1)
Day 1 2 hr
|
0.002 Liters
Standard Error 0.016
|
0.166 Liters
Standard Error 0.022
|
0.230 Liters
Standard Error 0.021
|
0.245 Liters
Standard Error 0.019
|
0.261 Liters
Standard Error 0.024
|
0.161 Liters
Standard Error 0.019
|
|
Change From Baseline in Forced Expiratory Volume in One Second (FEV1)
Day 1 3 hr
|
0.018 Liters
Standard Error 0.014
|
0.201 Liters
Standard Error 0.022
|
0.287 Liters
Standard Error 0.022
|
0.274 Liters
Standard Error 0.024
|
0.321 Liters
Standard Error 0.023
|
0.184 Liters
Standard Error 0.020
|
|
Change From Baseline in Forced Expiratory Volume in One Second (FEV1)
Day 1 4 hr
|
0.015 Liters
Standard Error 0.014
|
0.225 Liters
Standard Error 0.021
|
0.308 Liters
Standard Error 0.023
|
0.308 Liters
Standard Error 0.024
|
0.341 Liters
Standard Error 0.173
|
0.179 Liters
Standard Error 0.018
|
|
Change From Baseline in Forced Expiratory Volume in One Second (FEV1)
Day 1 6 hr
|
-0.005 Liters
Standard Error 0.017
|
0.216 Liters
Standard Error 0.028
|
0.276 Liters
Standard Error 0.024
|
0.276 Liters
Standard Error 0.022
|
0.311 Liters
Standard Error 0.031
|
0.135 Liters
Standard Error 0.018
|
|
Change From Baseline in Forced Expiratory Volume in One Second (FEV1)
Day 1 8 hr
|
0.007 Liters
Standard Error 0.016
|
0.169 Liters
Standard Error 0.025
|
0.260 Liters
Standard Error 0.025
|
0.263 Liters
Standard Error 0.024
|
0.313 Liters
Standard Error 0.025
|
0.124 Liters
Standard Error 0.021
|
|
Change From Baseline in Forced Expiratory Volume in One Second (FEV1)
Day 1 12 hr
|
-0.047 Liters
Standard Error 0.017
|
0.115 Liters
Standard Error 0.025
|
0.189 Liters
Standard Error 0.027
|
0.202 Liters
Standard Error 0.027
|
0.271 Liters
Standard Error 0.026
|
0.085 Liters
Standard Error 0.023
|
|
Change From Baseline in Forced Expiratory Volume in One Second (FEV1)
Day 1 14 hr
|
-0.067 Liters
Standard Error 0.020
|
0.099 Liters
Standard Error 0.026
|
0.180 Liters
Standard Error 0.026
|
0.214 Liters
Standard Error 0.24
|
0.250 Liters
Standard Error 0.026
|
0.087 Liters
Standard Error 0.022
|
|
Change From Baseline in Forced Expiratory Volume in One Second (FEV1)
Day 2 23 hr
|
-0.066 Liters
Standard Error 0.017
|
0.036 Liters
Standard Error 0.023
|
0.134 Liters
Standard Error 0.026
|
0.166 Liters
Standard Error 0.022
|
0.211 Liters
Standard Error 0.030
|
0.050 Liters
Standard Error 0.022
|
|
Change From Baseline in Forced Expiratory Volume in One Second (FEV1)
Day 2 36 hr
|
-0.020 Liters
Standard Error 0.020
|
0.040 Liters
Standard Error 0.024
|
0.104 Liters
Standard Error 0.022
|
0.083 Liters
Standard Error 0.023
|
0.116 Liters
Standard Error 0.024
|
0.036 Liters
Standard Error 0.021
|
SECONDARY outcome
Timeframe: Up to Day 2Population: ITT population defined as patients who took at least one dose of investigational medicinal product and had at least a baseline and one post-dose value of FEV1 from at least one treatment period
At each time point, three technically adequate lung function measurements were performed by spirometry according to the acceptability and repeatability criteria of the ATS/ERS; the highest values for the FEV1 and FVC were selected
Outcome measures
| Measure |
Placebo
n=68 Participants
Single dose administered by inhalation from the Genuair® device and the Breezhaler® inhaler
|
LAS100977 0.625 μg
n=67 Participants
Single dose administered by inhalation from the Genuair® device
|
LAS100977 2.5 μg
n=66 Participants
Single dose administered by inhalation from the Genuair® device
|
LAS100977 5 μg
n=66 Participants
Single dose administered by inhalation from the Genuair® device
|
LAS100977 10 μg
n=67 Participants
Single dose administered by inhalation from the Genuair® device
|
Indacaterol 150 μg
n=68 Participants
Single dose administered by inhalation from the Breezhaler® inhaler
|
|---|---|---|---|---|---|---|
|
Absolute Forced Expiratory Volume in One Second (FEV1) Values
Baseline
|
1.475 Liters
Standard Error 0.059
|
1.506 Liters
Standard Error 0.065
|
1.472 Liters
Standard Error 0.062
|
1.483 Liters
Standard Error 0.063
|
1.493 Liters
Standard Error 0.065
|
1.488 Liters
Standard Error 0.064
|
|
Absolute Forced Expiratory Volume in One Second (FEV1) Values
Day 1 12 hr
|
1.428 Liters
Standard Error 0.061
|
1.629 Liters
Standard Error 0.069
|
1.660 Liters
Standard Error 0.066
|
1.686 Liters
Standard Error 0.068
|
1.761 Liters
Standard Error 0.073
|
1.565 Liters
Standard Error 0.067
|
|
Absolute Forced Expiratory Volume in One Second (FEV1) Values
Day 1 0.08 hr
|
1.474 Liters
Standard Error 0.060
|
1.549 Liters
Standard Error 0.064
|
1.561 Liters
Standard Error 0.064
|
1.568 Liters
Standard Error 0.062
|
1.610 Liters
Standard Error 0.065
|
1.585 Liters
Standard Error 0.064
|
|
Absolute Forced Expiratory Volume in One Second (FEV1) Values
Day 1 0.25 hr
|
1.482 Liters
Standard Error 0.059
|
1.592 Liters
Standard Error 0.064
|
1.627 Liters
Standard Error 0.063
|
1.644 Liters
Standard Error 0.064
|
1.673 Liters
Standard Error 0.066
|
1.620 Liters
Standard Error 0.063
|
|
Absolute Forced Expiratory Volume in One Second (FEV1) Values
Day 1 0.5 hr
|
1.494 Liters
Standard Error 0.060
|
1.640 Liters
Standard Error 0.064
|
1.658 Liters
Standard Error 0.063
|
1.685 Liters
Standard Error 0.065
|
1.708 Liters
Standard Error 0.067
|
1.683 Liters
Standard Error 0.065
|
|
Absolute Forced Expiratory Volume in One Second (FEV1) Values
Day 1 1 hr
|
1.485 Liters
Standard Error 0.061
|
1.657 Liters
Standard Error 0.066
|
1.688 Liters
Standard Error 0.065
|
1.701 Liters
Standard Error 0.067
|
1.733 Liters
Standard Error 0.069
|
1.624 Liters
Standard Error 0.061
|
|
Absolute Forced Expiratory Volume in One Second (FEV1) Values
Day 1 2 hr
|
1.477 Liters
Standard Error 0.061
|
1.671 Liters
Standard Error 0.067
|
1.701 Liters
Standard Error 0.067
|
1.729 Liters
Standard Error 0.067
|
1.754 Liters
Standard Error 0.068
|
1.642 Liters
Standard Error 0.066
|
|
Absolute Forced Expiratory Volume in One Second (FEV1) Values
Day 1 3 hr
|
1.494 Liters
Standard Error 0.061
|
1.707 Liters
Standard Error 0.069
|
1.758 Liters
Standard Error 0.068
|
1.758 Liters
Standard Error 0.069
|
1.814 Liters
Standard Error 0.071
|
1.672 Liters
Standard Error 0.066
|
|
Absolute Forced Expiratory Volume in One Second (FEV1) Values
Day 1 4 hr
|
1.491 Liters
Standard Error 0.061
|
1.730 Liters
Standard Error 0.068
|
1.780 Liters
Standard Error 0.068
|
1.790 Liters
Standard Error 0.070
|
1.840 Liters
Standard Error 0.073
|
1.677 Liters
Standard Error 0.067
|
|
Absolute Forced Expiratory Volume in One Second (FEV1) Values
Day 1 6 hr
|
1.477 Liters
Standard Error 0.062
|
1.721 Liters
Standard Error 0.070
|
1.748 Liters
Standard Error 0.070
|
1.759 Liters
Standard Error 0.069
|
1.804 Liters
Standard Error 0.074
|
1.623 Liters
Standard Error 0.065
|
|
Absolute Forced Expiratory Volume in One Second (FEV1) Values
Day 1 8 hr
|
1.490 Liters
Standard Error 0.062
|
1.674 Liters
Standard Error 0.070
|
1.732 Liters
Standard Error 0.070
|
1.746 Liters
Standard Error 0.070
|
1.806 Liters
Standard Error 0.073
|
1.612 Liters
Standard Error 0.065
|
|
Absolute Forced Expiratory Volume in One Second (FEV1) Values
Day 1 14 hr
|
1.409 Liters
Standard Error 0.061
|
1.605 Liters
Standard Error 0.068
|
1.646 Liters
Standard Error 0.068
|
1.693 Liters
Standard Error 0.069
|
1.740 Liters
Standard Error 0.072
|
1.585 Liters
Standard Error 0.065
|
|
Absolute Forced Expiratory Volume in One Second (FEV1) Values
Day 2 23 hr
|
1.411 Liters
Standard Error 0.061
|
1.542 Liters
Standard Error 0.068
|
1.606 Liters
Standard Error 0.070
|
1.649 Liters
Standard Error 0.070
|
1.701 Liters
Standard Error 0.074
|
1.538 Liters
Standard Error 0.064
|
|
Absolute Forced Expiratory Volume in One Second (FEV1) Values
Day 2 24 hr
|
1.464 Liters
Standard Error 0.062
|
1.599 Liters
Standard Error 0.070
|
1.655 Liters
Standard Error 0.071
|
1.688 Liters
Standard Error 0.070
|
1.726 Liters
Standard Error 0.073
|
1.576 Liters
Standard Error 0.066
|
|
Absolute Forced Expiratory Volume in One Second (FEV1) Values
Day 2 36 hr
|
1.464 Liters
Standard Error 0.064
|
1.564 Liters
Standard Error 0.068
|
1.575 Liters
Standard Error 0.068
|
1.566 Liters
Standard Error 0.069
|
1.607 Liters
Standard Error 0.069
|
1.524 Liters
Standard Error 0.064
|
SECONDARY outcome
Timeframe: Day 1Population: ITT population defined as patients who took at least one dose of investigational medicinal product and had at least a baseline and one post-dose value of FEV1 from at least one treatment period
Baseline was the average of the two values measured just prior to the administration of the dose of investigational medicinal product at Day 1 of each visit (time points -45 min and -15 min) At each time point, three technically adequate lung function measurements were performed by spirometry according to the acceptability and repeatability criteria of the ATS/ERS; the highest values for the FEV1 and FVC were selected
Outcome measures
| Measure |
Placebo
n=68 Participants
Single dose administered by inhalation from the Genuair® device and the Breezhaler® inhaler
|
LAS100977 0.625 μg
n=67 Participants
Single dose administered by inhalation from the Genuair® device
|
LAS100977 2.5 μg
n=66 Participants
Single dose administered by inhalation from the Genuair® device
|
LAS100977 5 μg
n=66 Participants
Single dose administered by inhalation from the Genuair® device
|
LAS100977 10 μg
n=67 Participants
Single dose administered by inhalation from the Genuair® device
|
Indacaterol 150 μg
n=68 Participants
Single dose administered by inhalation from the Breezhaler® inhaler
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Peak Forced Expiratory Volume in One Second (FEV1)
|
0.098 Liters
Standard Error 0.016
|
0.290 Liters
Standard Error 0.025
|
0.351 Liters
Standard Error 0.022
|
0.350 Liters
Standard Error 0.023
|
0.391 Liters
Standard Error 0.024
|
0.263 Liters
Standard Error 0.019
|
SECONDARY outcome
Timeframe: Day 1Population: ITT population defined as patients who took at least one dose of investigational medicinal product and had at least a baseline and one post-dose value of FEV1 from at least one treatment period
At each time point, three technically adequate lung function measurements were performed by spirometry according to the acceptability and repeatability criteria of the ATS/ERS; the highest values for the FEV1 and FVC were selected
Outcome measures
| Measure |
Placebo
n=68 Participants
Single dose administered by inhalation from the Genuair® device and the Breezhaler® inhaler
|
LAS100977 0.625 μg
n=67 Participants
Single dose administered by inhalation from the Genuair® device
|
LAS100977 2.5 μg
n=66 Participants
Single dose administered by inhalation from the Genuair® device
|
LAS100977 5 μg
n=66 Participants
Single dose administered by inhalation from the Genuair® device
|
LAS100977 10 μg
n=67 Participants
Single dose administered by inhalation from the Genuair® device
|
Indacaterol 150 μg
n=68 Participants
Single dose administered by inhalation from the Breezhaler® inhaler
|
|---|---|---|---|---|---|---|
|
Time to Peak Forced Expiratory Volume in One Second (FEV1)
|
2.5 Hours
Standard Error 0.2
|
3.4 Hours
Standard Error 0.2
|
3.5 Hours
Standard Error 0.2
|
3.7 Hours
Standard Error 0.2
|
4.0 Hours
Standard Error 0.2
|
2.9 Hours
Standard Error 0.2
|
SECONDARY outcome
Timeframe: Day 2Population: ITT population defined as patients who took at least one dose of investigational medicinal product and had at least a baseline and one post-dose value of FEV1 from at least one treatment period
Baseline was the average of the two values measured just prior to the administration of the dose of investigational medicinal product at Day 1 of each visit (time points -45 min and -15 min) Trough at Day 2 was computed as the average of the two values measured at 23 and 24 hours after administration of the morning dose of investigational medicinal product on Day 1 At each time point, three technically adequate lung function measurements were performed by spirometry according to the acceptability and repeatability criteria of the ATS/ERS; the highest values for the FEV1 and FVC were selected
Outcome measures
| Measure |
Placebo
n=68 Participants
Single dose administered by inhalation from the Genuair® device and the Breezhaler® inhaler
|
LAS100977 0.625 μg
n=67 Participants
Single dose administered by inhalation from the Genuair® device
|
LAS100977 2.5 μg
n=66 Participants
Single dose administered by inhalation from the Genuair® device
|
LAS100977 5 μg
n=66 Participants
Single dose administered by inhalation from the Genuair® device
|
LAS100977 10 μg
n=67 Participants
Single dose administered by inhalation from the Genuair® device
|
Indacaterol 150 μg
n=68 Participants
Single dose administered by inhalation from the Breezhaler® inhaler
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Trough Forced Vital Capacity (FVC)
|
-0.079 Liters
Standard Error 0.044
|
0.067 Liters
Standard Error 0.044
|
0.180 Liters
Standard Error 0.044
|
0.217 Liters
Standard Error 0.044
|
0.254 Liters
Standard Error 0.044
|
0.088 Liters
Standard Error 0.044
|
SECONDARY outcome
Timeframe: Day 1Population: ITT population defined as patients who took at least one dose of investigational medicinal product and had at least a baseline and one post-dose value of FEV1 from at least one treatment period
Baseline was the average of the two values measured just prior to the administration of the dose of investigational medicinal product at Day 1 of each visit (time points -45 min and -15 min) At each time point, three technically adequate lung function measurements were performed by spirometry according to the acceptability and repeatability criteria of the ATS/ERS; the highest values for the FEV1 and FVC were selected
Outcome measures
| Measure |
Placebo
n=68 Participants
Single dose administered by inhalation from the Genuair® device and the Breezhaler® inhaler
|
LAS100977 0.625 μg
n=67 Participants
Single dose administered by inhalation from the Genuair® device
|
LAS100977 2.5 μg
n=66 Participants
Single dose administered by inhalation from the Genuair® device
|
LAS100977 5 μg
n=66 Participants
Single dose administered by inhalation from the Genuair® device
|
LAS100977 10 μg
n=67 Participants
Single dose administered by inhalation from the Genuair® device
|
Indacaterol 150 μg
n=68 Participants
Single dose administered by inhalation from the Breezhaler® inhaler
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Normalised Forced Vital Capacity (FVC) Area Under the Curve
Change from baseline in FVC AUC0-12
|
0.026 Liters
Standard Error 0.026
|
0.253 Liters
Standard Error 0.037
|
0.297 Liters
Standard Error 0.036
|
0.306 Liters
Standard Error 0.034
|
0.372 Liters
Standard Error 0.037
|
0.237 Liters
Standard Error 0.033
|
|
Change From Baseline in Normalised Forced Vital Capacity (FVC) Area Under the Curve
Change from baseline in FVC AUC0-24
|
-0.034 Liters
Standard Error 0.027
|
0.170 Liters
Standard Error 0.036
|
0.253 Liters
Standard Error 0.039
|
0.272 Liters
Standard Error 0.035
|
0.328 Liters
Standard Error 0.038
|
0.175 Liters
Standard Error 0.033
|
|
Change From Baseline in Normalised Forced Vital Capacity (FVC) Area Under the Curve
Change from baseline in FVC AUC12-24
|
-0.096 Liters
Standard Error 0.031
|
0.089 Liters
Standard Error 0.039
|
0.208 Liters
Standard Error 0.045
|
0.236 Liters
Standard Error 0.039
|
0.284 Liters
Standard Error 0.042
|
0.114 Liters
Standard Error 0.037
|
SECONDARY outcome
Timeframe: Up to Day 2Population: ITT population defined as patients who took at least one dose of investigational medicinal product and had at least a baseline and one post-dose value of FEV1 from at least one treatment period
Baseline was the average of the two values measured just prior to the administration of the dose of investigational medicinal product at Day 1 of each visit (time points -45 min and -15 min) At each time point, three technically adequate lung function measurements were performed by spirometry according to the acceptability and repeatability criteria of the ATS/ERS; the highest values for the FEV1 and FVC were selected
Outcome measures
| Measure |
Placebo
n=68 Participants
Single dose administered by inhalation from the Genuair® device and the Breezhaler® inhaler
|
LAS100977 0.625 μg
n=67 Participants
Single dose administered by inhalation from the Genuair® device
|
LAS100977 2.5 μg
n=66 Participants
Single dose administered by inhalation from the Genuair® device
|
LAS100977 5 μg
n=66 Participants
Single dose administered by inhalation from the Genuair® device
|
LAS100977 10 μg
n=67 Participants
Single dose administered by inhalation from the Genuair® device
|
Indacaterol 150 μg
n=68 Participants
Single dose administered by inhalation from the Breezhaler® inhaler
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Forced Vital Capacity (FVC)
Day 1 3 hr
|
0.020 Liters
Standard Error 0.026
|
0.248 Liters
Standard Error 0.044
|
0.338 Liters
Standard Error 0.041
|
0.325 Liters
Standard Error 0.041
|
0.392 Liters
Standard Error 0.039
|
0.274 Liters
Standard Error 0.037
|
|
Change From Baseline in Forced Vital Capacity (FVC)
Day 1 4 hr
|
0.016 Liters
Standard Error 0.030
|
0.297 Liters
Standard Error 0.042
|
0.379 Liters
Standard Error 0.039
|
0.337 Liters
Standard Error 0.042
|
0.402 Liters
Standard Error 0.035
|
0.254 Liters
Standard Error 0.035
|
|
Change From Baseline in Forced Vital Capacity (FVC)
Day 1 12 hr
|
-0.035 Liters
Standard Error 0.038
|
0.198 Liters
Standard Error 0.048
|
0.259 Liters
Standard Error 0.046
|
0.272 Liters
Standard Error 0.050
|
0.329 Liters
Standard Error 0.048
|
0.182 Liters
Standard Error 0.047
|
|
Change From Baseline in Forced Vital Capacity (FVC)
Day 1 14 hr
|
-0.110 Liters
Standard Error 0.043
|
0.107 Liters
Standard Error 0.047
|
0.236 Liters
Standard Error 0.050
|
0.266 Liters
Standard Error 0.043
|
0.315 Liters
Standard Error 0.046
|
0.148 Liters
Standard Error 0.045
|
|
Change From Baseline in Forced Vital Capacity (FVC)
Day 2 23 hr
|
-0.093 Liters
Standard Error 0.037
|
0.039 Liters
Standard Error 0.042
|
0.153 Liters
Standard Error 0.050
|
0.187 Liters
Standard Error 0.044
|
0.244 Liters
Standard Error 0.051
|
0.063 Liters
Standard Error 0.041
|
|
Change From Baseline in Forced Vital Capacity (FVC)
Day 1 2 hr
|
0.036 Liters
Standard Error 0.035
|
0.224 Liters
Standard Error 0.041
|
0.0269 Liters
Standard Error 0.040
|
0.300 Liters
Standard Error 0.035
|
0.303 Liters
Standard Error 0.042
|
0.244 Liters
Standard Error 0.036
|
|
Change From Baseline in Forced Vital Capacity (FVC)
Baseline
|
3.165 Liters
Standard Error 0.101
|
3.195 Liters
Standard Error 0.104
|
3.137 Liters
Standard Error 0.102
|
3.153 Liters
Standard Error 0.094
|
3.212 Liters
Standard Error 0.108
|
3.190 Liters
Standard Error 0.106
|
|
Change From Baseline in Forced Vital Capacity (FVC)
Day 1 0.08 hr
|
0.048 Liters
Standard Error 0.026
|
0.098 Liters
Standard Error 0.027
|
0.166 Liters
Standard Error 0.034
|
0.178 Liters
Standard Error 0.027
|
0.267 Liters
Standard Error 0.040
|
0.221 Liters
Standard Error 0.034
|
|
Change From Baseline in Forced Vital Capacity (FVC)
Day 1 0.25 hr
|
0.004 Liters
Standard Error 0.027
|
0.140 Liters
Standard Error 0.033
|
0.193 Liters
Standard Error 0.037
|
0.212 Liters
Standard Error 0.033
|
0.264 Liters
Standard Error 0.036
|
0.192 Liters
Standard Error 0.035
|
|
Change From Baseline in Forced Vital Capacity (FVC)
Day 1 0.5 hr
|
0.127 Liters
Standard Error 0.085
|
0.191 Liters
Standard Error 0.035
|
0.232 Liters
Standard Error 0.037
|
0.263 Liters
Standard Error 0.036
|
0.277 Liters
Standard Error 0.037
|
0.246 Liters
Standard Error 0.036
|
|
Change From Baseline in Forced Vital Capacity (FVC)
Day 1 1 hr
|
0.052 Liters
Standard Error 0.029
|
0.242 Liters
Standard Error 0.041
|
0.263 Liters
Standard Error 0.043
|
0.241 Liters
Standard Error 0.036
|
0.289 Liters
Standard Error 0.042
|
0.246 Liters
Standard Error 0.041
|
|
Change From Baseline in Forced Vital Capacity (FVC)
Day 1 6 hr
|
0.036 Liters
Standard Error 0.034
|
0.340 Liters
Standard Error 0.048
|
0.327 Liters
Standard Error 0.044
|
0.348 Liters
Standard Error 0.042
|
0.415 Liters
Standard Error 0.044
|
0.231 Liters
Standard Error 0.036
|
|
Change From Baseline in Forced Vital Capacity (FVC)
Day 1 8 hr
|
0.048 Liters
Standard Error 0.037
|
0.263 Liters
Standard Error 0.045
|
0.309 Liters
Standard Error 0.044
|
0.335 Liters
Standard Error 0.040
|
0.425 Liters
Standard Error 0.050
|
0.266 Liters
Standard Error 0.046
|
|
Change From Baseline in Forced Vital Capacity (FVC)
Day 2 24 hr
|
-0.076 Liters
Standard Error 0.035
|
0.090 Liters
Standard Error 0.039
|
0.186 Liters
Standard Error 0.038
|
0.207 Liters
Standard Error 0.039
|
0.243 Liters
Standard Error 0.046
|
0.100 Liters
Standard Error 0.040
|
|
Change From Baseline in Forced Vital Capacity (FVC)
Day 2 36 hr
|
-0.023 Liters
Standard Error 0.037
|
0.063 Liters
Standard Error 0.040
|
0.114 Liters
Standard Error 0.045
|
0.059 Liters
Standard Error 0.038
|
0.140 Liters
Standard Error 0.040
|
0.084 Liters
Standard Error 0.040
|
SECONDARY outcome
Timeframe: Up to Day 2Population: ITT population defined as patients who took at least one dose of investigational medicinal product and had at least a baseline and one post-dose value of FEV1 from at least one treatment period
At each time point, three technically adequate lung function measurements were performed by spirometry according to the acceptability and repeatability criteria of the ATS/ERS; the highest values for the FEV1 and FVC were selected
Outcome measures
| Measure |
Placebo
n=68 Participants
Single dose administered by inhalation from the Genuair® device and the Breezhaler® inhaler
|
LAS100977 0.625 μg
n=67 Participants
Single dose administered by inhalation from the Genuair® device
|
LAS100977 2.5 μg
n=66 Participants
Single dose administered by inhalation from the Genuair® device
|
LAS100977 5 μg
n=66 Participants
Single dose administered by inhalation from the Genuair® device
|
LAS100977 10 μg
n=67 Participants
Single dose administered by inhalation from the Genuair® device
|
Indacaterol 150 μg
n=68 Participants
Single dose administered by inhalation from the Breezhaler® inhaler
|
|---|---|---|---|---|---|---|
|
Absolute Forced Vital Capacity (FVC) Values
Day 1 3 hr
|
3.185 Liters
Standard Error 0.099
|
3.443 Liters
Standard Error 0.109
|
3.475 Liters
Standard Error 0.106
|
3.478 Liters
Standard Error 0.103
|
3.603 Liters
Standard Error 0.116
|
3.464 Liters
Standard Error 0.110
|
|
Absolute Forced Vital Capacity (FVC) Values
Baseline
|
3.165 Liters
Standard Error 0.101
|
3.195 Liters
Standard Error 0.104
|
3.137 Liters
Standard Error 0.102
|
3.153 Liters
Standard Error 0.094
|
3.212 Liters
Standard Error 0.108
|
3.190 Liters
Standard Error 0.106
|
|
Absolute Forced Vital Capacity (FVC) Values
Day 1 0.08 hr
|
3.205 Liters
Standard Error 0.106
|
3.293 Liters
Standard Error 0.112
|
3.318 Liters
Standard Error 0.105
|
3.331 Liters
Standard Error 0.100
|
3.479 Liters
Standard Error 0.116
|
3.418 Liters
Standard Error 0.117
|
|
Absolute Forced Vital Capacity (FVC) Values
Day 1 6 hr
|
3.220 Liters
Standard Error 0.097
|
3.535 Liters
Standard Error 0.118
|
3.464 Liters
Standard Error 0.109
|
3.501 Liters
Standard Error 0.109
|
3.626 Liters
Standard Error 0.119
|
3.421 Liters
Standard Error 0.109
|
|
Absolute Forced Vital Capacity (FVC) Values
Day 1 0.25 hr
|
3.169 Liters
Standard Error 0.098
|
3.335 Liters
Standard Error 0.109
|
3.329 Liters
Standard Error 0.102
|
3.365 Liters
Standard Error 0.100
|
3.455 Liters
Standard Error 0.111
|
3.382 Liters
Standard Error 0.107
|
|
Absolute Forced Vital Capacity (FVC) Values
Day 1 0.5 hr
|
3.292 Liters
Standard Error 0.126
|
3.399 Liters
Standard Error 0.110
|
3.368 Liters
Standard Error 0.105
|
3.417 Liters
Standard Error 0.101
|
3.488 Liters
Standard Error 0.112
|
3.441 Liters
Standard Error 0.110
|
|
Absolute Forced Vital Capacity (FVC) Values
Day 1 1 hr
|
3.217 Liters
Standard Error 0.104
|
3.436 Liters
Standard Error 0.110
|
3.400 Liters
Standard Error 0.107
|
3.394 Liters
Standard Error 0.102
|
3.501 Liters
Standard Error 0.114
|
3.415 Liters
Standard Error 0.111
|
|
Absolute Forced Vital Capacity (FVC) Values
Day 1 2 hr
|
3.201 Liters
Standard Error 0.101
|
3.418 Liters
Standard Error 0.111
|
3.406 Liters
Standard Error 0.107
|
3.454 Liters
Standard Error 0.102
|
3.514 Liters
Standard Error 0.109
|
3.415 Liters
Standard Error 0.108
|
|
Absolute Forced Vital Capacity (FVC) Values
Day 1 4 hr
|
3.181 Liters
Standard Error 0.101
|
3.492 Liters
Standard Error 0.108
|
3.516 Liters
Standard Error 0.103
|
3.478 Liters
Standard Error 0.099
|
3.608 Liters
Standard Error 0.114
|
3.448 Liters
Standard Error 0.110
|
|
Absolute Forced Vital Capacity (FVC) Values
Day 1 8 hr
|
3.232 Liters
Standard Error 0.103
|
3.458 Liters
Standard Error 0.114
|
3.445 Liters
Standard Error 0.110
|
3.488 Liters
Standard Error 0.107
|
3.636 Liters
Standard Error 0.122
|
3.469 Liters
Standard Error 0.116
|
|
Absolute Forced Vital Capacity (FVC) Values
Day 1 12 hr
|
3.130 Liters
Standard Error 0.105
|
3.406 Liters
Standard Error 0.118
|
3.396 Liters
Standard Error 0.108
|
3.425 Liters
Standard Error 0.105
|
3.534 Liters
Standard Error 0.119
|
3.367 Liters
Standard Error 0.115
|
|
Absolute Forced Vital Capacity (FVC) Values
Day 1 14 hr
|
3.055 Liters
Standard Error 0.107
|
3.302 Liters
Standard Error 0.112
|
3.359 Liters
Standard Error 0.111
|
3.411 Liters
Standard Error 0.107
|
3.520 Liters
Standard Error 0.118
|
3.348 Liters
Standard Error 0.118
|
|
Absolute Forced Vital Capacity (FVC) Values
Day 2 23 hr
|
3.075 Liters
Standard Error 0.108
|
3.233 Liters
Standard Error 0.111
|
3.290 Liters
Standard Error 0.107
|
3.341 Liters
Standard Error 0.107
|
3.448 Liters
Standard Error 0.117
|
3.257 Liters
Standard Error 0.106
|
|
Absolute Forced Vital Capacity (FVC) Values
Day 2 24 hr
|
3.095 Liters
Standard Error 0.103
|
3.284 Liters
Standard Error 0.109
|
3.323 Liters
Standard Error 0.104
|
3.360 Liters
Standard Error 0.102
|
3.447 Liters
Standard Error 0.110
|
3.295 Liters
Standard Error 0.107
|
|
Absolute Forced Vital Capacity (FVC) Values
Day 2 36 hr
|
3.145 Liters
Standard Error 0.102
|
3.289 Liters
Standard Error 0.109
|
3.251 Liters
Standard Error 0.108
|
3.212 Liters
Standard Error 0.102
|
3.345 Liters
Standard Error 0.110
|
3.274 Liters
Standard Error 0.105
|
SECONDARY outcome
Timeframe: Day 1Population: ITT population defined as patients who took at least one dose of investigational medicinal product and had at least a baseline and one post-dose value of FEV1 from at least one treatment period
Baseline was the average of the two values measured just prior to the administration of the dose of investigational medicinal product at Day 1 of each visit (time points -45 min and -15 min) At each time point, three technically adequate lung function measurements were performed by spirometry according to the acceptability and repeatability criteria of the ATS/ERS; the highest values for the FEV1 and FVC were selected
Outcome measures
| Measure |
Placebo
n=68 Participants
Single dose administered by inhalation from the Genuair® device and the Breezhaler® inhaler
|
LAS100977 0.625 μg
n=67 Participants
Single dose administered by inhalation from the Genuair® device
|
LAS100977 2.5 μg
n=66 Participants
Single dose administered by inhalation from the Genuair® device
|
LAS100977 5 μg
n=66 Participants
Single dose administered by inhalation from the Genuair® device
|
LAS100977 10 μg
n=67 Participants
Single dose administered by inhalation from the Genuair® device
|
Indacaterol 150 μg
n=68 Participants
Single dose administered by inhalation from the Breezhaler® inhaler
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Peak Forced Vital Capacity (FVC)
|
0.332 Liters
Standard Error 0.050
|
0.484 Liters
Standard Error 0.050
|
0.523 Liters
Standard Error 0.050
|
0.532 Liters
Standard Error 0.050
|
0.575 Liters
Standard Error 0.050
|
0.470 Liters
Standard Error 0.050
|
SECONDARY outcome
Timeframe: Day 1Population: ITT population defined as patients who took at least one dose of investigational medicinal product and had at least a baseline and one post-dose value of FEV1 from at least one treatment period
At each time point, three technically adequate lung function measurements were performed by spirometry according to the acceptability and repeatability criteria of the ATS/ERS; the highest values for the FEV1 and FVC were selected
Outcome measures
| Measure |
Placebo
n=68 Participants
Single dose administered by inhalation from the Genuair® device and the Breezhaler® inhaler
|
LAS100977 0.625 μg
n=67 Participants
Single dose administered by inhalation from the Genuair® device
|
LAS100977 2.5 μg
n=66 Participants
Single dose administered by inhalation from the Genuair® device
|
LAS100977 5 μg
n=66 Participants
Single dose administered by inhalation from the Genuair® device
|
LAS100977 10 μg
n=67 Participants
Single dose administered by inhalation from the Genuair® device
|
Indacaterol 150 μg
n=68 Participants
Single dose administered by inhalation from the Breezhaler® inhaler
|
|---|---|---|---|---|---|---|
|
Time to Peak Forced Vital Capacity (FVC)
|
2.4 Hours
Standard Error 0.3
|
3.6 Hours
Standard Error 0.3
|
3.4 Hours
Standard Error 0.2
|
3.1 Hours
Standard Error 0.2
|
3.6 Hours
Standard Error 0.3
|
2.6 Hours
Standard Error 0.3
|
SECONDARY outcome
Timeframe: Up to Day 2Population: ITT population defined as patients who took at least one dose of investigational medicinal product and had at least a baseline and one post-dose value of FEV1 from at least one treatment period
Baseline was the average of the two values measured just prior to the administration of the dose of investigational medicinal product at Day 1 of each visit (time points -45 min and -15 min) At each time point, three technically adequate lung function measurements were performed by spirometry according to the acceptability and repeatability criteria of the ATS/ERS
Outcome measures
| Measure |
Placebo
n=68 Participants
Single dose administered by inhalation from the Genuair® device and the Breezhaler® inhaler
|
LAS100977 0.625 μg
n=67 Participants
Single dose administered by inhalation from the Genuair® device
|
LAS100977 2.5 μg
n=66 Participants
Single dose administered by inhalation from the Genuair® device
|
LAS100977 5 μg
n=66 Participants
Single dose administered by inhalation from the Genuair® device
|
LAS100977 10 μg
n=67 Participants
Single dose administered by inhalation from the Genuair® device
|
Indacaterol 150 μg
n=68 Participants
Single dose administered by inhalation from the Breezhaler® inhaler
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Inspiratory Capacity (IC)
Baseline
|
2.240 Liters
Standard Error 0.082
|
2.239 Liters
Standard Error 0.078
|
2.234 Liters
Standard Error 0.075
|
2.254 Liters
Standard Error 0.077
|
2.237 Liters
Standard Error 0.077
|
2.246 Liters
Standard Error 0.076
|
|
Change From Baseline in Inspiratory Capacity (IC)
Day 1 4 hr
|
0.004 Liters
Standard Error 0.037
|
0.260 Liters
Standard Error 0.039
|
0.239 Liters
Standard Error 0.040
|
0.316 Liters
Standard Error 0.043
|
0.370 Liters
Standard Error 0.043
|
0.215 Liters
Standard Error 0.036
|
|
Change From Baseline in Inspiratory Capacity (IC)
Day 2 24 hr
|
-0.047 Liters
Standard Error 0.040
|
0.110 Liters
Standard Error 0.037
|
0.157 Liters
Standard Error 0.037
|
0.174 Liters
Standard Error 0.038
|
0.273 Liters
Standard Error 0.046
|
0.136 Liters
Standard Error 0.035
|
SECONDARY outcome
Timeframe: Up to Day 2Population: ITT population defined as patients who took at least one dose of investigational medicinal product and had at least a baseline and one post-dose value of FEV1 from at least one treatment period
At each time point, three technically adequate lung function measurements were performed by spirometry according to the acceptability and repeatability criteria of the ATS/ERS
Outcome measures
| Measure |
Placebo
n=68 Participants
Single dose administered by inhalation from the Genuair® device and the Breezhaler® inhaler
|
LAS100977 0.625 μg
n=67 Participants
Single dose administered by inhalation from the Genuair® device
|
LAS100977 2.5 μg
n=66 Participants
Single dose administered by inhalation from the Genuair® device
|
LAS100977 5 μg
n=66 Participants
Single dose administered by inhalation from the Genuair® device
|
LAS100977 10 μg
n=67 Participants
Single dose administered by inhalation from the Genuair® device
|
Indacaterol 150 μg
n=68 Participants
Single dose administered by inhalation from the Breezhaler® inhaler
|
|---|---|---|---|---|---|---|
|
Absolute Inspiratory Capacity (IC) Values
Baseline
|
2.240 Liters
Standard Error 0.082
|
2.239 Liters
Standard Error 0.078
|
2.234 Liters
Standard Error 0.075
|
2.254 Liters
Standard Error 0.077
|
2.237 Liters
Standard Error 0.077
|
2.246 Liters
Standard Error 0.076
|
|
Absolute Inspiratory Capacity (IC) Values
Day 1 4 hr
|
2.279 Liters
Standard Error 0.076
|
2.504 Liters
Standard Error 0.081
|
2.473 Liters
Standard Error 0.083
|
2.548 Liters
Standard Error 0.088
|
2.623 Liters
Standard Error 0.088
|
2.447 Liters
Standard Error 0.079
|
|
Absolute Inspiratory Capacity (IC) Values
Day 2 24 hr
|
2.203 Liters
Standard Error 0.074
|
2.374 Liters
Standard Error 0.082
|
2.398 Liters
Standard Error 0.085
|
2.402 Liters
Standard Error 0.081
|
2.543 Liters
Standard Error 0.086
|
2.380 Liters
Standard Error 0.077
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
LAS100977 0.625 μg
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
LAS100977 2.5 μg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
LAS100977 5 μg
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
LAS100977 10 μg
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
Indacaterol 150 μg
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=68 participants at risk
Single dose administered by inhalation from the Genuair® device and the Breezhaler® inhaler
|
LAS100977 0.625 μg
n=67 participants at risk
Single dose administered by inhalation from the Genuair® device
|
LAS100977 2.5 μg
n=66 participants at risk
Single dose administered by inhalation from the Genuair® device
|
LAS100977 5 μg
n=66 participants at risk
Single dose administered by inhalation from the Genuair® device
|
LAS100977 10 μg
n=67 participants at risk
Single dose administered by inhalation from the Genuair® device
|
Indacaterol 150 μg
n=68 participants at risk
Single dose administered by inhalation from the Breezhaler® inhaler
|
|---|---|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
COPD exacerbation
|
0.00%
0/68 • Up to 14 (±2) days after the last investigational medicinal product administration
|
0.00%
0/67 • Up to 14 (±2) days after the last investigational medicinal product administration
|
0.00%
0/66 • Up to 14 (±2) days after the last investigational medicinal product administration
|
1.5%
1/66 • Up to 14 (±2) days after the last investigational medicinal product administration
|
0.00%
0/67 • Up to 14 (±2) days after the last investigational medicinal product administration
|
0.00%
0/68 • Up to 14 (±2) days after the last investigational medicinal product administration
|
|
Nervous system disorders
Dizziness
|
0.00%
0/68 • Up to 14 (±2) days after the last investigational medicinal product administration
|
0.00%
0/67 • Up to 14 (±2) days after the last investigational medicinal product administration
|
0.00%
0/66 • Up to 14 (±2) days after the last investigational medicinal product administration
|
0.00%
0/66 • Up to 14 (±2) days after the last investigational medicinal product administration
|
1.5%
1/67 • Up to 14 (±2) days after the last investigational medicinal product administration
|
0.00%
0/68 • Up to 14 (±2) days after the last investigational medicinal product administration
|
Other adverse events
| Measure |
Placebo
n=68 participants at risk
Single dose administered by inhalation from the Genuair® device and the Breezhaler® inhaler
|
LAS100977 0.625 μg
n=67 participants at risk
Single dose administered by inhalation from the Genuair® device
|
LAS100977 2.5 μg
n=66 participants at risk
Single dose administered by inhalation from the Genuair® device
|
LAS100977 5 μg
n=66 participants at risk
Single dose administered by inhalation from the Genuair® device
|
LAS100977 10 μg
n=67 participants at risk
Single dose administered by inhalation from the Genuair® device
|
Indacaterol 150 μg
n=68 participants at risk
Single dose administered by inhalation from the Breezhaler® inhaler
|
|---|---|---|---|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
2.9%
2/68 • Up to 14 (±2) days after the last investigational medicinal product administration
|
6.0%
4/67 • Up to 14 (±2) days after the last investigational medicinal product administration
|
1.5%
1/66 • Up to 14 (±2) days after the last investigational medicinal product administration
|
1.5%
1/66 • Up to 14 (±2) days after the last investigational medicinal product administration
|
3.0%
2/67 • Up to 14 (±2) days after the last investigational medicinal product administration
|
7.4%
5/68 • Up to 14 (±2) days after the last investigational medicinal product administration
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Publication and/or presentation, whether complete or partial, of any part of the data or results of this trial will be subjected to revision and written agreement between the investigator and Sponsor
- Publication restrictions are in place
Restriction type: OTHER