Trial Outcomes & Findings for Swiss studY for the Treatment of COPD Patients With the Free combiNation of indacatERol and GlYcopyrroniumbromide. (NCT NCT01699685)
NCT ID: NCT01699685
Last Updated: 2016-02-09
Results Overview
IC was measured with spirometry conducted according to internationally accepted standards. Peak IC was defined as the maximum IC of the mean at one of the post-dose measurements (30min, 60min, 120min, 180min and 240min).
COMPLETED
PHASE3
79 participants
Day (0) 30minutes, 1, 2, 3, and 4 hours; Day (6) 30 minutes, 1, 2, 3, and 4 hours
2016-02-09
Participant Flow
Participant milestones
| Measure |
Sequence A
QAB149 (150μg puff) + placebo followed by QAB149 (150μg puff) + NVA237 (50μg puff)
|
Sequence B
QAB149 (150μg puff) + NVA237 (50μg puff) followed by QAB149 (150μg puff) + placebo
|
|---|---|---|
|
Period 1
STARTED
|
39
|
39
|
|
Period 1
Safety Population
|
39
|
38
|
|
Period 1
Full Analysis Population (FAS)
|
38
|
38
|
|
Period 1
COMPLETED
|
36
|
36
|
|
Period 1
NOT COMPLETED
|
3
|
3
|
|
Period 2
STARTED
|
36
|
36
|
|
Period 2
COMPLETED
|
35
|
36
|
|
Period 2
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Sequence A
QAB149 (150μg puff) + placebo followed by QAB149 (150μg puff) + NVA237 (50μg puff)
|
Sequence B
QAB149 (150μg puff) + NVA237 (50μg puff) followed by QAB149 (150μg puff) + placebo
|
|---|---|---|
|
Period 1
Adverse Event
|
1
|
1
|
|
Period 1
Medical or ethical, noncompliance
|
2
|
0
|
|
Period 1
Other
|
0
|
1
|
|
Period 1
Patient request
|
0
|
1
|
|
Period 2
Lost to Follow-up
|
1
|
0
|
Baseline Characteristics
Swiss studY for the Treatment of COPD Patients With the Free combiNation of indacatERol and GlYcopyrroniumbromide.
Baseline characteristics by cohort
| Measure |
Sequence A
n=39 Participants
QAB149 (150μg puff) + placebo followed by QAB149 (150μg puff) + NVA237 (50μg puff)
|
Sequence B
n=38 Participants
QAB149 (150μg puff) + NVA237 (50μg puff) followed by QAB149 (150μg puff) + placebo
|
Total
n=77 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
65.62 Years
STANDARD_DEVIATION 9.247 • n=99 Participants
|
64.18 Years
STANDARD_DEVIATION 7.447 • n=107 Participants
|
64.91 Years
STANDARD_DEVIATION 8.383 • n=206 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
31 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=99 Participants
|
21 Participants
n=107 Participants
|
46 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Day (0) 30minutes, 1, 2, 3, and 4 hours; Day (6) 30 minutes, 1, 2, 3, and 4 hoursPopulation: Full analysis set (FAS) included all randomized patients who received at least one dose of study medication during at least one study period. Participants with observations after 4 hours were included in the analysis.
IC was measured with spirometry conducted according to internationally accepted standards. Peak IC was defined as the maximum IC of the mean at one of the post-dose measurements (30min, 60min, 120min, 180min and 240min).
Outcome measures
| Measure |
Sequence A
n=38 Participants
QAB149 (150μg puff) + placebo followed by QAB149 (150μg puff) + NVA237 (50μg puff)
|
Sequence B
n=38 Participants
QAB149 (150μg puff) + NVA237 (50μg puff) followed by QAB149 (150μg puff) + placebo
|
|---|---|---|
|
Inspiratory Capacity (IC) Peak Value
Day 0 (n=38, 38)
|
2.87 Liters
Standard Deviation 0.808
|
2.94 Liters
Standard Deviation 0.777
|
|
Inspiratory Capacity (IC) Peak Value
Day 6 (n=36, 36)
|
2.99 Liters
Standard Deviation 0.856
|
2.85 Liters
Standard Deviation 0.707
|
SECONDARY outcome
Timeframe: Day (0) 30minutes, 1, 2, 3, and 4 hours; Day (6) 30 minutes, 1, 2, 3, and 4 hoursPopulation: Full analysis set (FAS) included all randomized patients who received at least one dose of study medication during at least one study period. Participants with observations after 4 hours were included in the analysis
FEV1 was measured with spirometry conducted according to internationally accepted standards. FEV1 was at 30, 60, 120, 180, and 240 minutes post-dose. Spirometry equipment and performance of spirometric testing had to be in accordance with standards as outlined in the American Thoracic Society for the Standardization of Spirometry recommendations. The spirometry equipment used during the study had to meet or exceed these minimal ATS recommendations
Outcome measures
| Measure |
Sequence A
n=38 Participants
QAB149 (150μg puff) + placebo followed by QAB149 (150μg puff) + NVA237 (50μg puff)
|
Sequence B
n=38 Participants
QAB149 (150μg puff) + NVA237 (50μg puff) followed by QAB149 (150μg puff) + placebo
|
|---|---|---|
|
Forced Expiratory Volume in One Second (FEV1)
Day (0) 30 min post-dose
|
1.49 Liters
Standard Deviation 0.442
|
1.57 Liters
Standard Deviation 0.505
|
|
Forced Expiratory Volume in One Second (FEV1)
Day (0) 1 hour post-dose
|
1.50 Liters
Standard Deviation 0.440
|
1.60 Liters
Standard Deviation 0.506
|
|
Forced Expiratory Volume in One Second (FEV1)
Day (0) 2 hour post-dose
|
1.51 Liters
Standard Deviation 0.437
|
1.60 Liters
Standard Deviation 0.506
|
|
Forced Expiratory Volume in One Second (FEV1)
Day (0) 3 hour post-dose
|
1.53 Liters
Standard Deviation 0.430
|
1.59 Liters
Standard Deviation 0.500
|
|
Forced Expiratory Volume in One Second (FEV1)
Day (0) 4 hour post-dose
|
1.53 Liters
Standard Deviation 0.434
|
1.60 Liters
Standard Deviation 0.492
|
|
Forced Expiratory Volume in One Second (FEV1)
Day (6) 30 min post-dose
|
1.59 Liters
Standard Deviation 0.437
|
1.52 Liters
Standard Deviation 0.473
|
|
Forced Expiratory Volume in One Second (FEV1)
Day (6) 1 hour post-dose
|
1.63 Liters
Standard Deviation 0.465
|
1.53 Liters
Standard Deviation 0.463
|
|
Forced Expiratory Volume in One Second (FEV1)
Day (6) 2 hour post-dose
|
1.66 Liters
Standard Deviation 0.462
|
1.55 Liters
Standard Deviation 0.476
|
|
Forced Expiratory Volume in One Second (FEV1)
Day (6) 3 hour post-dose
|
1.65 Liters
Standard Deviation 0.455
|
1.56 Liters
Standard Deviation 0.470
|
|
Forced Expiratory Volume in One Second (FEV1)
Day (6) 4 hour post-dose
|
1.64 Liters
Standard Deviation 0.473
|
1.56 Liters
Standard Deviation 0.459
|
SECONDARY outcome
Timeframe: within 4h after dosingPopulation: Full analysis set (FAS) included all randomized patients who received at least one dose of study medication during at least one study period. Participants with observations after 4 hours were included in the analysis
During the 4 hours following inhalation of the study treatment, inspiratory capacity (IC) was measured with spirometry conducted according to internationally accepted standards. IC was measured at 30, 60, 120, 180, and 240 minutes post-dose
Outcome measures
| Measure |
Sequence A
n=38 Participants
QAB149 (150μg puff) + placebo followed by QAB149 (150μg puff) + NVA237 (50μg puff)
|
Sequence B
n=38 Participants
QAB149 (150μg puff) + NVA237 (50μg puff) followed by QAB149 (150μg puff) + placebo
|
|---|---|---|
|
Inspiratory Capacity (IC)
Day (0) 30 min post-dose
|
2.67 Liters
Standard Deviation 0.771
|
2.75 Liters
Standard Deviation 0.751
|
|
Inspiratory Capacity (IC)
Day (0) 1 hour post-dose
|
2.67 Liters
Standard Deviation 0.799
|
2.79 Liters
Standard Deviation 0.774
|
|
Inspiratory Capacity (IC)
Day (0) 2 hour post-dose
|
2.69 Liters
Standard Deviation 0.803
|
2.71 Liters
Standard Deviation 0.709
|
|
Inspiratory Capacity (IC)
Day (0) 3 hour post-dose
|
2.74 Liters
Standard Deviation 0.811
|
2.69 Liters
Standard Deviation 0.800
|
|
Inspiratory Capacity (IC)
Day (0) 4 hour post-dose
|
2.74 Liters
Standard Deviation 0.823
|
2.74 Liters
Standard Deviation 0.754
|
|
Inspiratory Capacity (IC)
Day (6) 30 min post-dose
|
2.79 Liters
Standard Deviation 0.826
|
2.40 Liters
Standard Deviation 0.724
|
|
Inspiratory Capacity (IC)
Day (6) 1 hour post-dose
|
2.80 Liters
Standard Deviation 0.810
|
2.72 Liters
Standard Deviation 0.759
|
|
Inspiratory Capacity (IC)
Day (6) 2 hour post-dose
|
2.86 Liters
Standard Deviation 0.846
|
2.74 Liters
Standard Deviation 0.689
|
|
Inspiratory Capacity (IC)
Day (6) 3 hour post-dose
|
2.83 Liters
Standard Deviation 0.841
|
2.69 Liters
Standard Deviation 0.719
|
|
Inspiratory Capacity (IC)
Day (6) 4 hour post-dose
|
2.85 Liters
Standard Deviation 0.799
|
2.68 Liters
Standard Deviation 0.699
|
SECONDARY outcome
Timeframe: Day (0) 30minutes, 1, 2, 3, and 4 hours; Day (6) 30 minutes, 1, 2, 3, and 4 hoursPopulation: Full analysis set (FAS) included all randomized patients who received at least one dose of study medication during at least one study period. Participants with observations after 4 hours were included in the analysis
FVC was measured with spirometry conducted according to internationally accepted standards. Measurements were made 30, 60, 120, 180, and 240 minutes post-dose. The standardized AUC FEV1 was calculated as the sum of trapezoids divided by the length of time
Outcome measures
| Measure |
Sequence A
n=38 Participants
QAB149 (150μg puff) + placebo followed by QAB149 (150μg puff) + NVA237 (50μg puff)
|
Sequence B
n=38 Participants
QAB149 (150μg puff) + NVA237 (50μg puff) followed by QAB149 (150μg puff) + placebo
|
|---|---|---|
|
Forced Volume Capacity (FVC)
Day (0) 30 min post-dose
|
2.98 Liters
Standard Deviation 0.917
|
3.00 Liters
Standard Deviation 0.839
|
|
Forced Volume Capacity (FVC)
Day (0) 1 hour post-dose
|
3.00 Liters
Standard Deviation 0.966
|
3.02 Liters
Standard Deviation 0.846
|
|
Forced Volume Capacity (FVC)
Day (0) 2 hour post-dose
|
3.01 Liters
Standard Deviation 0.947
|
3.04 Liters
Standard Deviation 0.862
|
|
Forced Volume Capacity (FVC)
Day (0) 3 hour post-dose
|
3.08 Liters
Standard Deviation 0.946
|
3.04 Liters
Standard Deviation 0.872
|
|
Forced Volume Capacity (FVC)
Day (0) 4 hour post-dose
|
3.07 Liters
Standard Deviation 0.968
|
3.07 Liters
Standard Deviation 0.852
|
|
Forced Volume Capacity (FVC)
Day (6) 30 min post-dose
|
3.19 Liters
Standard Deviation 1.002
|
2.96 Liters
Standard Deviation 0.788
|
|
Forced Volume Capacity (FVC)
Day (6) 1 hour post-dose
|
3.25 Liters
Standard Deviation 1.047
|
2.97 Liters
Standard Deviation 0.807
|
|
Forced Volume Capacity (FVC)
Day (6) 2 hour post-dose
|
3.29 Liters
Standard Deviation 1.018
|
2.99 Liters
Standard Deviation 0.754
|
|
Forced Volume Capacity (FVC)
Day (6) 3 hour post-dose
|
3.32 Liters
Standard Deviation 1.003
|
2.98 Liters
Standard Deviation 0.794
|
|
Forced Volume Capacity (FVC)
Day (6) 4 hour post-dose
|
3.30 Liters
Standard Deviation 1.012
|
2.96 Liters
Standard Deviation 0.797
|
SECONDARY outcome
Timeframe: Day (0) 30minutes, 1, 2, 3, and 4 hours; Day (6) 30 minutes, 1, 2, 3, and 4 hoursPopulation: Full analysis set (FAS) included all randomized patients who received at least one dose of study medication during at least one study period. Participants with observations after 4 hours were included in the analysis
TLC was measured with spirometry conducted according to internationally accepted standards. Peak TLC was calculated as the mean of the three Functional Residual Capacity peak measurements plus the mean of the three Inspiratory Capacity measurements which were measured each at 30, 60, 120, 180 and 240 minutes post dose
Outcome measures
| Measure |
Sequence A
n=38 Participants
QAB149 (150μg puff) + placebo followed by QAB149 (150μg puff) + NVA237 (50μg puff)
|
Sequence B
n=38 Participants
QAB149 (150μg puff) + NVA237 (50μg puff) followed by QAB149 (150μg puff) + placebo
|
|---|---|---|
|
Total Lung Capacity (TLC)
Day (0) 30 min post-dose
|
7.20 Liters
Standard Deviation 1.587
|
6.81 Liters
Standard Deviation 1.144
|
|
Total Lung Capacity (TLC)
Day (0) 1 hour post-dose
|
7.17 Liters
Standard Deviation 1.559
|
6.79 Liters
Standard Deviation 1.197
|
|
Total Lung Capacity (TLC)
Day (0) 2 hour post-dose
|
7.06 Liters
Standard Deviation 1.658
|
6.81 Liters
Standard Deviation 1.190
|
|
Total Lung Capacity (TLC)
Day (0) 3 hour post-dose
|
7.14 Liters
Standard Deviation 1.662
|
6.82 Liters
Standard Deviation 1.198
|
|
Total Lung Capacity (TLC)
Day (0) 4 hour post-dose
|
7.21 Liters
Standard Deviation 1.608
|
6.78 Liters
Standard Deviation 1.247
|
|
Total Lung Capacity (TLC)
Day (6) 30 min post-dose
|
7.20 Liters
Standard Deviation 1.664
|
6.79 Liters
Standard Deviation 1.243
|
|
Total Lung Capacity (TLC)
Day (6) 1 hour post-dose
|
7.12 Liters
Standard Deviation 1.576
|
6.80 Liters
Standard Deviation 1.312
|
|
Total Lung Capacity (TLC)
Day (6) 2 hour post-dose
|
7.21 Liters
Standard Deviation 1.641
|
6.80 Liters
Standard Deviation 1.213
|
|
Total Lung Capacity (TLC)
Day (6) 3 hour post-dose
|
7.23 Liters
Standard Deviation 1.561
|
6.81 Liters
Standard Deviation 1.304
|
|
Total Lung Capacity (TLC)
Day (6) 4 hour post-dose
|
7.30 Liters
Standard Deviation 1.691
|
6.93 Liters
Standard Deviation 1.376
|
SECONDARY outcome
Timeframe: Day (0) 30minutes, 1, 2, 3, and 4 hours; Day (6) 30 minutes, 1, 2, 3, and 4 hoursPopulation: Full analysis set (FAS) included all randomized patients who received at least one dose of study medication during at least one study period. Participants with observations after 4 hours were included in the analysis
Raw was measured with spirometry conducted according to internationally accepted standards. Raw was the mean of the measurements which were measured each at 30, 60, 120, 180 and 240 minutes
Outcome measures
| Measure |
Sequence A
n=38 Participants
QAB149 (150μg puff) + placebo followed by QAB149 (150μg puff) + NVA237 (50μg puff)
|
Sequence B
n=38 Participants
QAB149 (150μg puff) + NVA237 (50μg puff) followed by QAB149 (150μg puff) + placebo
|
|---|---|---|
|
Airway Resistance (Raw)
Day (0) 30 min post-dose
|
5.13 cmH2O/l/s
Standard Deviation 2.243
|
4.74 cmH2O/l/s
Standard Deviation 1.810
|
|
Airway Resistance (Raw)
Day (0) 1 hour post-dose
|
5.19 cmH2O/l/s
Standard Deviation 2.561
|
4.61 cmH2O/l/s
Standard Deviation 1.881
|
|
Airway Resistance (Raw)
Day (0) 2 hour post-dose
|
5.21 cmH2O/l/s
Standard Deviation 2.496
|
4.43 cmH2O/l/s
Standard Deviation 1.849
|
|
Airway Resistance (Raw)
Day (0) 3 hour post-dose
|
5.07 cmH2O/l/s
Standard Deviation 2.528
|
4.53 cmH2O/l/s
Standard Deviation 1.748
|
|
Airway Resistance (Raw)
Day (0) 4 hour post-dose
|
5.18 cmH2O/l/s
Standard Deviation 2.535
|
4.48 cmH2O/l/s
Standard Deviation 1.866
|
|
Airway Resistance (Raw)
Day (6) 30 min post-dose
|
4.73 cmH2O/l/s
Standard Deviation 2.540
|
5.18 cmH2O/l/s
Standard Deviation 2.130
|
|
Airway Resistance (Raw)
Day (6) 1 hour post-dose
|
4.47 cmH2O/l/s
Standard Deviation 2.323
|
4.97 cmH2O/l/s
Standard Deviation 1.861
|
|
Airway Resistance (Raw)
Day (6) 2 hour post-dose
|
4.31 cmH2O/l/s
Standard Deviation 2.119
|
4.71 cmH2O/l/s
Standard Deviation 1.822
|
|
Airway Resistance (Raw)
Day (6) 3 hour post-dose
|
4.30 cmH2O/l/s
Standard Deviation 2.161
|
4.77 cmH2O/l/s
Standard Deviation 1.989
|
|
Airway Resistance (Raw)
Day (6) 4 hour post-dose
|
4.30 cmH2O/l/s
Standard Deviation 2.170
|
4.78 cmH2O/l/s
Standard Deviation 1.939
|
Adverse Events
Sequence A
Sequence B
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Sequence A
n=39 participants at risk
QAB149 (150μg puff) + placebo followed by QAB149 (150μg puff) + NVA237 (50μg puff)
|
Sequence B
n=38 participants at risk
QAB149 (150μg puff) + NVA237 (50μg puff) followed by QAB149 (150μg puff) + placebo
|
|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
2.6%
1/39
|
0.00%
0/38
|
|
Investigations
Forced expiratory volume decreased
|
2.6%
1/39
|
2.6%
1/38
|
|
Investigations
Inspiratory capacity decreased
|
2.6%
1/39
|
0.00%
0/38
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/39
|
2.6%
1/38
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
2.6%
1/39
|
2.6%
1/38
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
2.6%
1/39
|
0.00%
0/38
|
Additional Information
Study Director
Novartis Pharmaceuticals
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 or disclosure of trial results in their entirety.
- Publication restrictions are in place
Restriction type: OTHER