Trial Outcomes & Findings for Efficacy and Safety Study of QVA149 in COPD Patients (NCT NCT02487446)
NCT ID: NCT02487446
Last Updated: 2017-12-26
Results Overview
FEV1 was measured with spirometry conducted according to internationally accepted standards. The standardized AUC FEV1 was calculated as the sum of trapezoids divided by the length of time over an entire day (AUC 0-24h). A positive change from baseline indicates improvement.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
357 participants
Primary outcome timeframe
baseline, 0 to 24 hours post-dose at week 12
Results posted on
2017-12-26
Participant Flow
Participants were randomized to 1 of 2 sequences in a 1:1 ratio.
Participant milestones
| Measure |
First QVA149, Then Umeclidinium/Vilanterol
Participants received QVA149 27.5/12.5 ug via inhalation twice daily (b.i.d.) for 12 weeks. Then after 3 weeks washout, participants received Umeclidinium/vilanterol 62.5/25 ug via inhalation once daily for 12 weeks.
|
First Umeclidinium/Vilanterol, Then QVA149
Participants received Umeclidinium/vilanterol 62.5/25 ug via inhalation once daily for 12 weeks. Then after 3 weeks washout, participants received QVA149 27.5/12.5 ug via inhalation twice daily (b.i.d.) for 12 weeks.
|
|---|---|---|
|
Period 1
STARTED
|
178
|
179
|
|
Period 1
COMPLETED
|
165
|
171
|
|
Period 1
NOT COMPLETED
|
13
|
8
|
|
Washout
STARTED
|
165
|
171
|
|
Washout
COMPLETED
|
162
|
163
|
|
Washout
NOT COMPLETED
|
3
|
8
|
|
Period 2
STARTED
|
162
|
163
|
|
Period 2
COMPLETED
|
154
|
158
|
|
Period 2
NOT COMPLETED
|
8
|
5
|
Reasons for withdrawal
| Measure |
First QVA149, Then Umeclidinium/Vilanterol
Participants received QVA149 27.5/12.5 ug via inhalation twice daily (b.i.d.) for 12 weeks. Then after 3 weeks washout, participants received Umeclidinium/vilanterol 62.5/25 ug via inhalation once daily for 12 weeks.
|
First Umeclidinium/Vilanterol, Then QVA149
Participants received Umeclidinium/vilanterol 62.5/25 ug via inhalation once daily for 12 weeks. Then after 3 weeks washout, participants received QVA149 27.5/12.5 ug via inhalation twice daily (b.i.d.) for 12 weeks.
|
|---|---|---|
|
Period 1
Physician Decision
|
0
|
1
|
|
Period 1
Lack of Efficacy
|
1
|
0
|
|
Period 1
Protocol deviation
|
3
|
2
|
|
Period 1
Lost to Follow-up
|
2
|
0
|
|
Period 1
Withdrawal by Subject
|
2
|
0
|
|
Period 1
Adverse Event
|
5
|
5
|
|
Washout
Lost to Follow-up
|
0
|
2
|
|
Washout
Withdrawal by Subject
|
1
|
4
|
|
Washout
Adverse Event
|
2
|
2
|
|
Period 2
Protocol deviation
|
0
|
1
|
|
Period 2
Lost to Follow-up
|
1
|
1
|
|
Period 2
Withdrawal by Subject
|
1
|
1
|
|
Period 2
Adverse Event
|
6
|
2
|
Baseline Characteristics
Efficacy and Safety Study of QVA149 in COPD Patients
Baseline characteristics by cohort
| Measure |
Overall Participants
n=357 Participants
Participants received QVA149 27.5/12.5 ug via inhalation twice daily (b.i.d.) for 12 weeks and Umeclidinium/vilanterol 62.5/25 ug via inhalation once daily for 12 weeks.
|
|---|---|
|
Age, Continuous
|
64.1 Years
STANDARD_DEVIATION 8.21 • n=5 Participants
|
|
Sex: Female, Male
Female
|
171 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
186 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: baseline, 0 to 24 hours post-dose at week 12Population: The full analysis, which included all randomized patients who received at least one dose of double-blind treatment, was considered for the analysis. Only participants with a value at both baseline and the post-baseline time point were included in the analysis.
FEV1 was measured with spirometry conducted according to internationally accepted standards. The standardized AUC FEV1 was calculated as the sum of trapezoids divided by the length of time over an entire day (AUC 0-24h). A positive change from baseline indicates improvement.
Outcome measures
| Measure |
QVA149
n=315 Participants
Participants received QVA149 27.5/12.5 ug via inhalation twice daily (b.i.d.) for 12 weeks.
|
Umeclidinium/Vilanterol
n=319 Participants
Participants received Umeclidinium/vilanterol 62.5/25 ug via inhalation b.i.d. for 12 weeks.
|
|---|---|---|
|
Change From Baseline in Forced Expiratory Volume (FEV1) Area Under the Curve (AUC) 0-24h
|
0.2321 Liters
Standard Error 0.01133
|
0.2436 Liters
Standard Error 0.01130
|
SECONDARY outcome
Timeframe: baseline, 0 to 24 hours post-dose at week 12Population: The full analysis, which included all randomized patients who received at least one dose of double-blind treatment, was considered for the analysis. Only participants with a value at both baseline and post-baseline time point were included in the analysis.
FEV1 was measured with spirometry conducted according to internationally accepted standards. The standardized AUC FEV1 was calculated as the sum of trapezoids divided by the length of time over an entire day (AUC 0-24h). A positive change from baseline indicates improvement.
Outcome measures
| Measure |
QVA149
n=315 Participants
Participants received QVA149 27.5/12.5 ug via inhalation twice daily (b.i.d.) for 12 weeks.
|
Umeclidinium/Vilanterol
n=319 Participants
Participants received Umeclidinium/vilanterol 62.5/25 ug via inhalation b.i.d. for 12 weeks.
|
|---|---|---|
|
Change From Baseline in Forced Expiratory Volume (FEV1) Area Under the Curve (AUC) 0-24h
|
0.2321 Liters
Standard Error 0.01133
|
0.2436 Liters
Standard Error 0.01130
|
SECONDARY outcome
Timeframe: baseline, 23 hours 15 minutes and 23 hours 45 minutes post previous morning dose at week 12Population: The full analysis, which included all randomized patients who received at least one dose of double-blind treatment, was considered for the analysis. Only participants with a value at both baseline and the post-baseline time point were included in the analysis.
FEV1 was measured with spirometry conducted according to internationally accepted standards. Trough FEV1 was defined as the average of measurements made 23 hours 15 minutes and 23 hours 45 minutes post-dose for each treatment
Outcome measures
| Measure |
QVA149
n=309 Participants
Participants received QVA149 27.5/12.5 ug via inhalation twice daily (b.i.d.) for 12 weeks.
|
Umeclidinium/Vilanterol
n=310 Participants
Participants received Umeclidinium/vilanterol 62.5/25 ug via inhalation b.i.d. for 12 weeks.
|
|---|---|---|
|
Change From Baseline in Trough FEV1 (Mean of 23h 15 Minutes and 23 h 45 Minutes Post Previous Morning Dose)
|
0.1891 Liters
Standard Error 0.01070
|
0.2043 Liters
Standard Error 0.01069
|
SECONDARY outcome
Timeframe: baseline, 12 hours to 24 hours post-dose at week 12Population: The full analysis, which included all randomized patients who received at least one dose of double-blind treatment, was considered for the analysis. Only participants with a value at both baseline and the post-baseline time point were included in the analysis.
FEV1 was measured with spirometry conducted according to internationally accepted standards. The standardized AUC FEV1 was calculated as the sum of trapezoids divided by the length of time over 12 hours (AUC 12-24h).
Outcome measures
| Measure |
QVA149
n=312 Participants
Participants received QVA149 27.5/12.5 ug via inhalation twice daily (b.i.d.) for 12 weeks.
|
Umeclidinium/Vilanterol
n=316 Participants
Participants received Umeclidinium/vilanterol 62.5/25 ug via inhalation b.i.d. for 12 weeks.
|
|---|---|---|
|
Change From Baseline in FEV1 AUC 12-24h
|
0.2076 Liters
Standard Error 0.01159
|
0.2025 Liters
Standard Error 0.01156
|
SECONDARY outcome
Timeframe: baseline, 0 to 12 hours post-dose at week 12Population: The full analysis, which included all randomized patients who received at least one dose of double-blind treatment, was considered for the analysis. Only participants with a value at both baseline and the post-baseline time point were included in the analysis.
FEV1 was measured with spirometry conducted according to internationally accepted standards. The standardized AUC FEV1 was calculated as the sum of trapezoids divided by the length of time over 12 hours (AUC 0-12h).
Outcome measures
| Measure |
QVA149
n=313 Participants
Participants received QVA149 27.5/12.5 ug via inhalation twice daily (b.i.d.) for 12 weeks.
|
Umeclidinium/Vilanterol
n=319 Participants
Participants received Umeclidinium/vilanterol 62.5/25 ug via inhalation b.i.d. for 12 weeks.
|
|---|---|---|
|
Change From Baseline in FEV1 AUC 0-12h
|
0.2543 Liter
Standard Error 0.01031
|
0.2848 Liter
Standard Error 0.01026
|
SECONDARY outcome
Timeframe: baseline, 12 weeksPopulation: The full analysis, which included all randomized patients who received at least one dose of double-blind treatment, was considered for the analysis. Only participants with a value at both baseline and the post-baseline time points were included in the analysis.
FEV1 was measured with spirometry conducted according to internationally accepted standards. The standardized AUC FEV1 was calculated as the sum of trapezoids divided by the length of time over 4 hour intervals FEV1 AUC 0-4h, AUC 4-8h, AUC 8-12h, AUC 12-16h, AUC 16-20h and AUC 20-24h.
Outcome measures
| Measure |
QVA149
n=341 Participants
Participants received QVA149 27.5/12.5 ug via inhalation twice daily (b.i.d.) for 12 weeks.
|
Umeclidinium/Vilanterol
n=340 Participants
Participants received Umeclidinium/vilanterol 62.5/25 ug via inhalation b.i.d. for 12 weeks.
|
|---|---|---|
|
Change From Baseline in FEV1 AUC 0-4h, AUC 4-8h, AUC 8-12h, AUC 12-16h, AUC 16-20h and AUC 20-24h
0-4h
|
0.3223 Liter
Standard Error 0.01087
|
0.3289 Liter
Standard Error 0.01080
|
|
Change From Baseline in FEV1 AUC 0-4h, AUC 4-8h, AUC 8-12h, AUC 12-16h, AUC 16-20h and AUC 20-24h
4-8h
|
0.2399 Liter
Standard Error 0.01051
|
0.2831 Liter
Standard Error 0.01045
|
|
Change From Baseline in FEV1 AUC 0-4h, AUC 4-8h, AUC 8-12h, AUC 12-16h, AUC 16-20h and AUC 20-24h
8-12h
|
0.1911 Liter
Standard Error 0.01069
|
0.2411 Liter
Standard Error 0.01062
|
|
Change From Baseline in FEV1 AUC 0-4h, AUC 4-8h, AUC 8-12h, AUC 12-16h, AUC 16-20h and AUC 20-24h
12-16h
|
0.2594 Liter
Standard Error 0.01241
|
0.2349 Liter
Standard Error 0.01236
|
|
Change From Baseline in FEV1 AUC 0-4h, AUC 4-8h, AUC 8-12h, AUC 12-16h, AUC 16-20h and AUC 20-24h
16-20h
|
0.1914 Liter
Standard Error 0.01247
|
0.1875 Liter
Standard Error 0.01244
|
|
Change From Baseline in FEV1 AUC 0-4h, AUC 4-8h, AUC 8-12h, AUC 12-16h, AUC 16-20h and AUC 20-24h
20-24h (n=310,314)
|
0.1722 Liter
Standard Error 0.01136
|
0.1821 Liter
Standard Error 0.01133
|
SECONDARY outcome
Timeframe: baseline, 15 minutes and 45 minutes pre morning dose at week 12Population: The full analysis, which included all randomized patients who received at least one dose of double-blind treatment, was considered for the analysis. Only participants with a value at both baseline and the post-baseline time point were included in the analysis.
FEV1 was measured with spirometry conducted according to internationally accepted standards. Pre-dose trough FEV1 was defined as the average of measurements made 15 minutes and 45 minutes pre morning dose for each treatment.
Outcome measures
| Measure |
QVA149
n=314 Participants
Participants received QVA149 27.5/12.5 ug via inhalation twice daily (b.i.d.) for 12 weeks.
|
Umeclidinium/Vilanterol
n=318 Participants
Participants received Umeclidinium/vilanterol 62.5/25 ug via inhalation b.i.d. for 12 weeks.
|
|---|---|---|
|
Change From Baseline in Pre-dose Trough FEV1 (Mean of 15 Minutes and 45 Minutes Pre Morning Dose)
|
0.2302 Liter
Standard Error 0.01138
|
0.2450 Liter
Standard Error 0.01135
|
SECONDARY outcome
Timeframe: Day 1 (5min, 15min, 30min, hours 1, 2, 4, 8, 11h 55min, 23h 15min, 23h 45min); week 6 (-45min, -15min); week 12 (-45min, -15min, 5min, 15min, 30min, hours 1, 2, 4, 8, 11h 55min, 12h 5min, 12h 15min, 12h 30min, 13, 14, 16, 20, 23h 15min, 23h 45min)Population: The full analysis, which included all randomized patients who received at least one dose of double-blind treatment, was considered for the analysis. Only participants with a value at both baseline and the post-baseline time points were included in the analysis.
FEV1 was measured with spirometry conducted according to internationally accepted standards.
Outcome measures
| Measure |
QVA149
n=341 Participants
Participants received QVA149 27.5/12.5 ug via inhalation twice daily (b.i.d.) for 12 weeks.
|
Umeclidinium/Vilanterol
n=340 Participants
Participants received Umeclidinium/vilanterol 62.5/25 ug via inhalation b.i.d. for 12 weeks.
|
|---|---|---|
|
QVA149 Compared to Umeclidinium/Vilanterol in Terms of Change From Baseline in FEV1 at Any Time Point
Week 6, -15 minutes
|
0.2378 Liter
Standard Error 0.01181
|
0.2668 Liter
Standard Error 0.01179
|
|
QVA149 Compared to Umeclidinium/Vilanterol in Terms of Change From Baseline in FEV1 at Any Time Point
Week 12, -45 minutes
|
0.2225 Liter
Standard Error 0.01149
|
0.2378 Liter
Standard Error 0.01146
|
|
QVA149 Compared to Umeclidinium/Vilanterol in Terms of Change From Baseline in FEV1 at Any Time Point
Week 12, 23 hours 15 minutes (n=299,305)
|
0.1791 Liter
Standard Error 0.01095
|
0.1981 Liter
Standard Error 0.01088
|
|
QVA149 Compared to Umeclidinium/Vilanterol in Terms of Change From Baseline in FEV1 at Any Time Point
Week 12, 23 hours 45 minutes
|
0.2048 Liter
Standard Error 0.01122
|
0.2117 Liter
Standard Error 0.01118
|
|
QVA149 Compared to Umeclidinium/Vilanterol in Terms of Change From Baseline in FEV1 at Any Time Point
Week 12, 14 hours
|
0.2667 Liter
Standard Error 0.01331
|
0.2355 Liter
Standard Error 0.01314
|
|
QVA149 Compared to Umeclidinium/Vilanterol in Terms of Change From Baseline in FEV1 at Any Time Point
Week 12, 16 hours
|
0.2230 Liter
Standard Error 0.01306
|
0.2197 Liter
Standard Error 0.01296
|
|
QVA149 Compared to Umeclidinium/Vilanterol in Terms of Change From Baseline in FEV1 at Any Time Point
Week 12, 20 hours
|
0.1622 Liter
Standard Error 0.01281
|
0.1629 Liter
Standard Error 0.01273
|
|
QVA149 Compared to Umeclidinium/Vilanterol in Terms of Change From Baseline in FEV1 at Any Time Point
Day 1, 5 minutes
|
0.1112 Liter
Standard Error 0.01011
|
0.1201 Liter
Standard Error 0.01007
|
|
QVA149 Compared to Umeclidinium/Vilanterol in Terms of Change From Baseline in FEV1 at Any Time Point
Day 1, 15 minutes
|
0.1509 Liter
Standard Error 0.01046
|
0.1682 Liter
Standard Error 0.01048
|
|
QVA149 Compared to Umeclidinium/Vilanterol in Terms of Change From Baseline in FEV1 at Any Time Point
Day 1, 30 minutes
|
0.1602 Liter
Standard Error 0.01071
|
0.1945 Liter
Standard Error 0.01073
|
|
QVA149 Compared to Umeclidinium/Vilanterol in Terms of Change From Baseline in FEV1 at Any Time Point
Day 1, 1 hour
|
0.1755 Liter
Standard Error 0.01105
|
0.2230 Liter
Standard Error 0.01100
|
|
QVA149 Compared to Umeclidinium/Vilanterol in Terms of Change From Baseline in FEV1 at Any Time Point
Day 1, 2 hours
|
0.1840 Liter
Standard Error 0.01161
|
0.2329 Liter
Standard Error 0.01157
|
|
QVA149 Compared to Umeclidinium/Vilanterol in Terms of Change From Baseline in FEV1 at Any Time Point
Day 1, 4 hours
|
0.1432 Liter
Standard Error 0.01107
|
0.2270 Liter
Standard Error 0.01105
|
|
QVA149 Compared to Umeclidinium/Vilanterol in Terms of Change From Baseline in FEV1 at Any Time Point
Day 1, 8 hours
|
0.0815 Liter
Standard Error 0.01054
|
0.1861 Liter
Standard Error 0.01056
|
|
QVA149 Compared to Umeclidinium/Vilanterol in Terms of Change From Baseline in FEV1 at Any Time Point
Day 1, 11 hours 55 minutes
|
0.0699 Liter
Standard Error 0.01153
|
0.1674 Liter
Standard Error 0.01138
|
|
QVA149 Compared to Umeclidinium/Vilanterol in Terms of Change From Baseline in FEV1 at Any Time Point
Day 1, 23 hours 15 minutes
|
0.1498 Liter
Standard Error 0.01078
|
0.1764 Liter
Standard Error 0.01063
|
|
QVA149 Compared to Umeclidinium/Vilanterol in Terms of Change From Baseline in FEV1 at Any Time Point
Day 1, 23 hours 45 minutes
|
0.1579 Liter
Standard Error 0.01103
|
0.1932 Liter
Standard Error 0.01090
|
|
QVA149 Compared to Umeclidinium/Vilanterol in Terms of Change From Baseline in FEV1 at Any Time Point
Week 6, -45 minutes
|
0.2122 Liter
Standard Error 0.01143
|
0.2469 Liter
Standard Error 0.01141
|
|
QVA149 Compared to Umeclidinium/Vilanterol in Terms of Change From Baseline in FEV1 at Any Time Point
Week 12, -15 minutes
|
0.2390 Liter
Standard Error 0.01182
|
0.2538 Liter
Standard Error 0.01179
|
|
QVA149 Compared to Umeclidinium/Vilanterol in Terms of Change From Baseline in FEV1 at Any Time Point
Week 12, 5 minutes
|
0.2879 Liter
Standard Error 0.01029
|
0.2831 Liter
Standard Error 0.01027
|
|
QVA149 Compared to Umeclidinium/Vilanterol in Terms of Change From Baseline in FEV1 at Any Time Point
Week 12, 15 minutes
|
0.3187 Liter
Standard Error 0.01079
|
0.3074 Liter
Standard Error 0.01074
|
|
QVA149 Compared to Umeclidinium/Vilanterol in Terms of Change From Baseline in FEV1 at Any Time Point
Week 12, 30 minutes
|
0.3346 Liter
Standard Error 0.01103
|
0.3258 Liter
Standard Error 0.01091
|
|
QVA149 Compared to Umeclidinium/Vilanterol in Terms of Change From Baseline in FEV1 at Any Time Point
Week 12, 1 hour
|
0.3426 Liter
Standard Error 0.01128
|
0.3334 Liter
Standard Error 0.01119
|
|
QVA149 Compared to Umeclidinium/Vilanterol in Terms of Change From Baseline in FEV1 at Any Time Point
Week 12, 2 hours
|
0.3343 Liter
Standard Error 0.01188
|
0.3445 Liter
Standard Error 0.01175
|
|
QVA149 Compared to Umeclidinium/Vilanterol in Terms of Change From Baseline in FEV1 at Any Time Point
Week 12, 4 hours
|
0.2760 Liter
Standard Error 0.01137
|
0.3137 Liter
Standard Error 0.01126
|
|
QVA149 Compared to Umeclidinium/Vilanterol in Terms of Change From Baseline in FEV1 at Any Time Point
Week 12, 8 hours
|
0.2033 Liter
Standard Error 0.01078
|
0.2545 Liter
Standard Error 0.01071
|
|
QVA149 Compared to Umeclidinium/Vilanterol in Terms of Change From Baseline in FEV1 at Any Time Point
Week 12, 11 hours 55 minutes
|
0.1764 Liter
Standard Error 0.01189
|
0.2311 Liter
Standard Error 0.01151
|
|
QVA149 Compared to Umeclidinium/Vilanterol in Terms of Change From Baseline in FEV1 at Any Time Point
Week 12, 12 hours 5 minutes
|
0.2343 Liter
Standard Error 0.01257
|
0.2218 Liter
Standard Error 0.01242
|
|
QVA149 Compared to Umeclidinium/Vilanterol in Terms of Change From Baseline in FEV1 at Any Time Point
Week 12, 12 hours 15 minutes
|
0.2465 Liter
Standard Error 0.01291
|
0.2324 Liter
Standard Error 0.01282
|
|
QVA149 Compared to Umeclidinium/Vilanterol in Terms of Change From Baseline in FEV1 at Any Time Point
Week 12, 12 hours 30 minutes
|
0.2695 Liter
Standard Error 0.01307
|
0.2350 Liter
Standard Error 0.01302
|
|
QVA149 Compared to Umeclidinium/Vilanterol in Terms of Change From Baseline in FEV1 at Any Time Point
Week 12, 13 hours
|
0.2749 Liter
Standard Error 0.01305
|
0.2448 Liter
Standard Error 0.01294
|
SECONDARY outcome
Timeframe: Day 1 (5min, 15min, 30min, hours 1, 2, 4, 8, 11h 55min, 23h 15min, 23h 45min); week 6 (-45min, -15min); week 12 (-45min, -15min, 5min, 15min, 30min, hours 1, 2, 4, 8, 11h 55min, 12h 5min, 12h 15min, 12h 30min, 13, 14, 16, 20, 23h 15min, 23h 45min)Population: The full analysis, which included all randomized patients who received at least one dose of double-blind treatment, was considered for the analysis. Only participants with a value at both baseline and the post-baseline time points were included in the analysis.
FEV1 was measured with spirometry conducted according to internationally accepted standards.
Outcome measures
| Measure |
QVA149
n=341 Participants
Participants received QVA149 27.5/12.5 ug via inhalation twice daily (b.i.d.) for 12 weeks.
|
Umeclidinium/Vilanterol
n=340 Participants
Participants received Umeclidinium/vilanterol 62.5/25 ug via inhalation b.i.d. for 12 weeks.
|
|---|---|---|
|
QVA149 Compared to Umeclidinium/Vilanterol in Terms of Change From Baseline in Forced Vital Capacity (FVC) at Any Time Point
Day 1, 5 minutes
|
0.2177 Liter
Standard Error 0.01732
|
0.2218 Liter
Standard Error 0.01726
|
|
QVA149 Compared to Umeclidinium/Vilanterol in Terms of Change From Baseline in Forced Vital Capacity (FVC) at Any Time Point
Day 1, 15 minutes
|
0.2566 Liter
Standard Error 0.01818
|
0.2927 Liter
Standard Error 0.01821
|
|
QVA149 Compared to Umeclidinium/Vilanterol in Terms of Change From Baseline in Forced Vital Capacity (FVC) at Any Time Point
Day 1, 30 minutes
|
0.2811 Liter
Standard Error 0.01846
|
0.3325 Liter
Standard Error 0.01849
|
|
QVA149 Compared to Umeclidinium/Vilanterol in Terms of Change From Baseline in Forced Vital Capacity (FVC) at Any Time Point
Day 1, 1 hour
|
0.2944 Liter
Standard Error 0.01912
|
0.3534 Liter
Standard Error 0.01904
|
|
QVA149 Compared to Umeclidinium/Vilanterol in Terms of Change From Baseline in Forced Vital Capacity (FVC) at Any Time Point
Day 1, 2 hours
|
0.3109 Liter
Standard Error 0.01966
|
0.3687 Liter
Standard Error 0.01960
|
|
QVA149 Compared to Umeclidinium/Vilanterol in Terms of Change From Baseline in Forced Vital Capacity (FVC) at Any Time Point
Day 1, 4 hours
|
0.2788 Liter
Standard Error 0.04347
|
0.4237 Liter
Standard Error 0.04339
|
|
QVA149 Compared to Umeclidinium/Vilanterol in Terms of Change From Baseline in Forced Vital Capacity (FVC) at Any Time Point
Day 1, 8 hours
|
0.1681 Liter
Standard Error 0.01816
|
0.3237 Liter
Standard Error 0.01818
|
|
QVA149 Compared to Umeclidinium/Vilanterol in Terms of Change From Baseline in Forced Vital Capacity (FVC) at Any Time Point
Day 1, 11 hours 55 minutes
|
0.1406 Liter
Standard Error 0.01915
|
0.2910 Liter
Standard Error 0.01889
|
|
QVA149 Compared to Umeclidinium/Vilanterol in Terms of Change From Baseline in Forced Vital Capacity (FVC) at Any Time Point
Day 1, 23 hours 15 minutes
|
0.2565 Liter
Standard Error 0.01777
|
0.2747 Liter
Standard Error 0.01753
|
|
QVA149 Compared to Umeclidinium/Vilanterol in Terms of Change From Baseline in Forced Vital Capacity (FVC) at Any Time Point
Day 1, 23 hours 45 minutes
|
0.2737 Liter
Standard Error 0.01903
|
0.3001 Liter
Standard Error 0.01883
|
|
QVA149 Compared to Umeclidinium/Vilanterol in Terms of Change From Baseline in Forced Vital Capacity (FVC) at Any Time Point
Week 6, -45 minutes
|
0.2914 Liter
Standard Error 0.01853
|
0.3513 Liter
Standard Error 0.01851
|
|
QVA149 Compared to Umeclidinium/Vilanterol in Terms of Change From Baseline in Forced Vital Capacity (FVC) at Any Time Point
Week 6, -15 minutes
|
0.3390 Liter
Standard Error 0.01922
|
0.3732 Liter
Standard Error 0.01919
|
|
QVA149 Compared to Umeclidinium/Vilanterol in Terms of Change From Baseline in Forced Vital Capacity (FVC) at Any Time Point
Week 12, -45 minutes
|
0.3044 Liter
Standard Error 0.01864
|
0.3442 Liter
Standard Error 0.01859
|
|
QVA149 Compared to Umeclidinium/Vilanterol in Terms of Change From Baseline in Forced Vital Capacity (FVC) at Any Time Point
Week 12, -15 minutes
|
0.3344 Liter
Standard Error 0.01923
|
0.3566 Liter
Standard Error 0.01919
|
|
QVA149 Compared to Umeclidinium/Vilanterol in Terms of Change From Baseline in Forced Vital Capacity (FVC) at Any Time Point
Week 12, 5 minutes
|
0.3960 Liter
Standard Error 0.01760
|
0.3861 Liter
Standard Error 0.01756
|
|
QVA149 Compared to Umeclidinium/Vilanterol in Terms of Change From Baseline in Forced Vital Capacity (FVC) at Any Time Point
Week 12, 15 minutes
|
0.4378 Liter
Standard Error 0.01865
|
0.4169 Liter
Standard Error 0.01857
|
|
QVA149 Compared to Umeclidinium/Vilanterol in Terms of Change From Baseline in Forced Vital Capacity (FVC) at Any Time Point
Week 12, 30 minutes
|
0.4602 Liter
Standard Error 0.01892
|
0.4480 Liter
Standard Error 0.01875
|
|
QVA149 Compared to Umeclidinium/Vilanterol in Terms of Change From Baseline in Forced Vital Capacity (FVC) at Any Time Point
Week 12, 1 hour
|
0.4649 Liter
Standard Error 0.01948
|
0.4647 Liter
Standard Error 0.01934
|
|
QVA149 Compared to Umeclidinium/Vilanterol in Terms of Change From Baseline in Forced Vital Capacity (FVC) at Any Time Point
Week 12, 2 hours
|
0.4405 Liter
Standard Error 0.02006
|
0.4853 Liter
Standard Error 0.01987
|
|
QVA149 Compared to Umeclidinium/Vilanterol in Terms of Change From Baseline in Forced Vital Capacity (FVC) at Any Time Point
Week 12, 4 hours
|
0.3872 Liter
Standard Error 0.04490
|
0.4343 Liter
Standard Error 0.04435
|
|
QVA149 Compared to Umeclidinium/Vilanterol in Terms of Change From Baseline in Forced Vital Capacity (FVC) at Any Time Point
Week 12, 8 hours
|
0.2714 Liter
Standard Error 0.01856
|
0.3555 Liter
Standard Error 0.01844
|
|
QVA149 Compared to Umeclidinium/Vilanterol in Terms of Change From Baseline in Forced Vital Capacity (FVC) at Any Time Point
Week 12, 11 hours 55 minutes
|
0.2306 Liter
Standard Error 0.01977
|
0.3231 Liter
Standard Error 0.01911
|
|
QVA149 Compared to Umeclidinium/Vilanterol in Terms of Change From Baseline in Forced Vital Capacity (FVC) at Any Time Point
Week 12, 12 hours 5 minutes (n=294,305)
|
0.3455 Liter
Standard Error 0.02063
|
0.3112 Liter
Standard Error 0.02038
|
|
QVA149 Compared to Umeclidinium/Vilanterol in Terms of Change From Baseline in Forced Vital Capacity (FVC) at Any Time Point
Week 12, 12 hours 15 minutes
|
0.3409 Liter
Standard Error 0.02086
|
0.3235 Liter
Standard Error 0.02070
|
|
QVA149 Compared to Umeclidinium/Vilanterol in Terms of Change From Baseline in Forced Vital Capacity (FVC) at Any Time Point
Week 12, 12 hours 30 minutes
|
0.3688 Liter
Standard Error 0.02196
|
0.3326 Liter
Standard Error 0.02187
|
|
QVA149 Compared to Umeclidinium/Vilanterol in Terms of Change From Baseline in Forced Vital Capacity (FVC) at Any Time Point
Week 12, 13 hours
|
0.3760 Liter
Standard Error 0.02123
|
0.3361 Liter
Standard Error 0.02104
|
|
QVA149 Compared to Umeclidinium/Vilanterol in Terms of Change From Baseline in Forced Vital Capacity (FVC) at Any Time Point
Week 12, 14 hours
|
0.3681 Liter
Standard Error 0.02192
|
0.3371 Liter
Standard Error 0.02162
|
|
QVA149 Compared to Umeclidinium/Vilanterol in Terms of Change From Baseline in Forced Vital Capacity (FVC) at Any Time Point
Week 12, 16 hours
|
0.3129 Liter
Standard Error 0.02205
|
0.3279 Liter
Standard Error 0.02189
|
|
QVA149 Compared to Umeclidinium/Vilanterol in Terms of Change From Baseline in Forced Vital Capacity (FVC) at Any Time Point
Week 12, 20 hours
|
0.2175 Liter
Standard Error 0.02180
|
0.2353 Liter
Standard Error 0.02167
|
|
QVA149 Compared to Umeclidinium/Vilanterol in Terms of Change From Baseline in Forced Vital Capacity (FVC) at Any Time Point
Week 12, 23 hours 15 minutes
|
0.2237 Liter
Standard Error 0.01804
|
0.2750 Liter
Standard Error 0.01792
|
|
QVA149 Compared to Umeclidinium/Vilanterol in Terms of Change From Baseline in Forced Vital Capacity (FVC) at Any Time Point
Week 12, 23 hours 45 minutes (n=300,303)
|
0.2607 Liter
Standard Error 0.01935
|
0.2728 Liter
Standard Error 0.01928
|
Adverse Events
QVA149
Serious events: 13 serious events
Other events: 85 other events
Deaths: 0 deaths
Umeclidinium/Vilanterol
Serious events: 21 serious events
Other events: 104 other events
Deaths: 0 deaths
All Patients
Serious events: 33 serious events
Other events: 161 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
QVA149
n=341 participants at risk
Participants received QVA149 27.5/12.5 ug via inhalation twice daily (b.i.d.) for 12 weeks.
|
Umeclidinium/Vilanterol
n=340 participants at risk
Participants received Umeclidinium/vilanterol 62.5/25 ug via inhalation b.i.d. for 12 weeks.
|
All Patients
n=356 participants at risk
All Patients
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/341
Since this is a cross-over design study, all patients were randomized to receive both treatments, either in sequence QVA/UV or sequence UV/QVA. The number of patients on each treatment does not add up to the total number of patients.
|
0.29%
1/340
Since this is a cross-over design study, all patients were randomized to receive both treatments, either in sequence QVA/UV or sequence UV/QVA. The number of patients on each treatment does not add up to the total number of patients.
|
0.28%
1/356
Since this is a cross-over design study, all patients were randomized to receive both treatments, either in sequence QVA/UV or sequence UV/QVA. The number of patients on each treatment does not add up to the total number of patients.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/341
Since this is a cross-over design study, all patients were randomized to receive both treatments, either in sequence QVA/UV or sequence UV/QVA. The number of patients on each treatment does not add up to the total number of patients.
|
0.29%
1/340
Since this is a cross-over design study, all patients were randomized to receive both treatments, either in sequence QVA/UV or sequence UV/QVA. The number of patients on each treatment does not add up to the total number of patients.
|
0.28%
1/356
Since this is a cross-over design study, all patients were randomized to receive both treatments, either in sequence QVA/UV or sequence UV/QVA. The number of patients on each treatment does not add up to the total number of patients.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/341
Since this is a cross-over design study, all patients were randomized to receive both treatments, either in sequence QVA/UV or sequence UV/QVA. The number of patients on each treatment does not add up to the total number of patients.
|
0.29%
1/340
Since this is a cross-over design study, all patients were randomized to receive both treatments, either in sequence QVA/UV or sequence UV/QVA. The number of patients on each treatment does not add up to the total number of patients.
|
0.28%
1/356
Since this is a cross-over design study, all patients were randomized to receive both treatments, either in sequence QVA/UV or sequence UV/QVA. The number of patients on each treatment does not add up to the total number of patients.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.29%
1/341
Since this is a cross-over design study, all patients were randomized to receive both treatments, either in sequence QVA/UV or sequence UV/QVA. The number of patients on each treatment does not add up to the total number of patients.
|
0.00%
0/340
Since this is a cross-over design study, all patients were randomized to receive both treatments, either in sequence QVA/UV or sequence UV/QVA. The number of patients on each treatment does not add up to the total number of patients.
|
0.28%
1/356
Since this is a cross-over design study, all patients were randomized to receive both treatments, either in sequence QVA/UV or sequence UV/QVA. The number of patients on each treatment does not add up to the total number of patients.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.29%
1/341
Since this is a cross-over design study, all patients were randomized to receive both treatments, either in sequence QVA/UV or sequence UV/QVA. The number of patients on each treatment does not add up to the total number of patients.
|
0.00%
0/340
Since this is a cross-over design study, all patients were randomized to receive both treatments, either in sequence QVA/UV or sequence UV/QVA. The number of patients on each treatment does not add up to the total number of patients.
|
0.28%
1/356
Since this is a cross-over design study, all patients were randomized to receive both treatments, either in sequence QVA/UV or sequence UV/QVA. The number of patients on each treatment does not add up to the total number of patients.
|
|
Cardiac disorders
Coronary artery disease
|
0.29%
1/341
Since this is a cross-over design study, all patients were randomized to receive both treatments, either in sequence QVA/UV or sequence UV/QVA. The number of patients on each treatment does not add up to the total number of patients.
|
0.00%
0/340
Since this is a cross-over design study, all patients were randomized to receive both treatments, either in sequence QVA/UV or sequence UV/QVA. The number of patients on each treatment does not add up to the total number of patients.
|
0.28%
1/356
Since this is a cross-over design study, all patients were randomized to receive both treatments, either in sequence QVA/UV or sequence UV/QVA. The number of patients on each treatment does not add up to the total number of patients.
|
|
Cardiac disorders
Mitral valve incompetence
|
0.29%
1/341
Since this is a cross-over design study, all patients were randomized to receive both treatments, either in sequence QVA/UV or sequence UV/QVA. The number of patients on each treatment does not add up to the total number of patients.
|
0.00%
0/340
Since this is a cross-over design study, all patients were randomized to receive both treatments, either in sequence QVA/UV or sequence UV/QVA. The number of patients on each treatment does not add up to the total number of patients.
|
0.28%
1/356
Since this is a cross-over design study, all patients were randomized to receive both treatments, either in sequence QVA/UV or sequence UV/QVA. The number of patients on each treatment does not add up to the total number of patients.
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.00%
0/341
Since this is a cross-over design study, all patients were randomized to receive both treatments, either in sequence QVA/UV or sequence UV/QVA. The number of patients on each treatment does not add up to the total number of patients.
|
0.29%
1/340
Since this is a cross-over design study, all patients were randomized to receive both treatments, either in sequence QVA/UV or sequence UV/QVA. The number of patients on each treatment does not add up to the total number of patients.
|
0.28%
1/356
Since this is a cross-over design study, all patients were randomized to receive both treatments, either in sequence QVA/UV or sequence UV/QVA. The number of patients on each treatment does not add up to the total number of patients.
|
|
Gastrointestinal disorders
Large intestinal haemorrhage
|
0.00%
0/341
Since this is a cross-over design study, all patients were randomized to receive both treatments, either in sequence QVA/UV or sequence UV/QVA. The number of patients on each treatment does not add up to the total number of patients.
|
0.29%
1/340
Since this is a cross-over design study, all patients were randomized to receive both treatments, either in sequence QVA/UV or sequence UV/QVA. The number of patients on each treatment does not add up to the total number of patients.
|
0.28%
1/356
Since this is a cross-over design study, all patients were randomized to receive both treatments, either in sequence QVA/UV or sequence UV/QVA. The number of patients on each treatment does not add up to the total number of patients.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.29%
1/341
Since this is a cross-over design study, all patients were randomized to receive both treatments, either in sequence QVA/UV or sequence UV/QVA. The number of patients on each treatment does not add up to the total number of patients.
|
0.00%
0/340
Since this is a cross-over design study, all patients were randomized to receive both treatments, either in sequence QVA/UV or sequence UV/QVA. The number of patients on each treatment does not add up to the total number of patients.
|
0.28%
1/356
Since this is a cross-over design study, all patients were randomized to receive both treatments, either in sequence QVA/UV or sequence UV/QVA. The number of patients on each treatment does not add up to the total number of patients.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/341
Since this is a cross-over design study, all patients were randomized to receive both treatments, either in sequence QVA/UV or sequence UV/QVA. The number of patients on each treatment does not add up to the total number of patients.
|
0.29%
1/340
Since this is a cross-over design study, all patients were randomized to receive both treatments, either in sequence QVA/UV or sequence UV/QVA. The number of patients on each treatment does not add up to the total number of patients.
|
0.28%
1/356
Since this is a cross-over design study, all patients were randomized to receive both treatments, either in sequence QVA/UV or sequence UV/QVA. The number of patients on each treatment does not add up to the total number of patients.
|
|
Infections and infestations
Appendicitis
|
0.29%
1/341
Since this is a cross-over design study, all patients were randomized to receive both treatments, either in sequence QVA/UV or sequence UV/QVA. The number of patients on each treatment does not add up to the total number of patients.
|
0.00%
0/340
Since this is a cross-over design study, all patients were randomized to receive both treatments, either in sequence QVA/UV or sequence UV/QVA. The number of patients on each treatment does not add up to the total number of patients.
|
0.28%
1/356
Since this is a cross-over design study, all patients were randomized to receive both treatments, either in sequence QVA/UV or sequence UV/QVA. The number of patients on each treatment does not add up to the total number of patients.
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/341
Since this is a cross-over design study, all patients were randomized to receive both treatments, either in sequence QVA/UV or sequence UV/QVA. The number of patients on each treatment does not add up to the total number of patients.
|
0.29%
1/340
Since this is a cross-over design study, all patients were randomized to receive both treatments, either in sequence QVA/UV or sequence UV/QVA. The number of patients on each treatment does not add up to the total number of patients.
|
0.28%
1/356
Since this is a cross-over design study, all patients were randomized to receive both treatments, either in sequence QVA/UV or sequence UV/QVA. The number of patients on each treatment does not add up to the total number of patients.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/341
Since this is a cross-over design study, all patients were randomized to receive both treatments, either in sequence QVA/UV or sequence UV/QVA. The number of patients on each treatment does not add up to the total number of patients.
|
0.29%
1/340
Since this is a cross-over design study, all patients were randomized to receive both treatments, either in sequence QVA/UV or sequence UV/QVA. The number of patients on each treatment does not add up to the total number of patients.
|
0.28%
1/356
Since this is a cross-over design study, all patients were randomized to receive both treatments, either in sequence QVA/UV or sequence UV/QVA. The number of patients on each treatment does not add up to the total number of patients.
|
|
Infections and infestations
Escherichia bacteraemia
|
0.00%
0/341
Since this is a cross-over design study, all patients were randomized to receive both treatments, either in sequence QVA/UV or sequence UV/QVA. The number of patients on each treatment does not add up to the total number of patients.
|
0.29%
1/340
Since this is a cross-over design study, all patients were randomized to receive both treatments, either in sequence QVA/UV or sequence UV/QVA. The number of patients on each treatment does not add up to the total number of patients.
|
0.28%
1/356
Since this is a cross-over design study, all patients were randomized to receive both treatments, either in sequence QVA/UV or sequence UV/QVA. The number of patients on each treatment does not add up to the total number of patients.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/341
Since this is a cross-over design study, all patients were randomized to receive both treatments, either in sequence QVA/UV or sequence UV/QVA. The number of patients on each treatment does not add up to the total number of patients.
|
0.29%
1/340
Since this is a cross-over design study, all patients were randomized to receive both treatments, either in sequence QVA/UV or sequence UV/QVA. The number of patients on each treatment does not add up to the total number of patients.
|
0.28%
1/356
Since this is a cross-over design study, all patients were randomized to receive both treatments, either in sequence QVA/UV or sequence UV/QVA. The number of patients on each treatment does not add up to the total number of patients.
|
|
Infections and infestations
Pneumonia
|
0.29%
1/341
Since this is a cross-over design study, all patients were randomized to receive both treatments, either in sequence QVA/UV or sequence UV/QVA. The number of patients on each treatment does not add up to the total number of patients.
|
1.5%
5/340
Since this is a cross-over design study, all patients were randomized to receive both treatments, either in sequence QVA/UV or sequence UV/QVA. The number of patients on each treatment does not add up to the total number of patients.
|
1.7%
6/356
Since this is a cross-over design study, all patients were randomized to receive both treatments, either in sequence QVA/UV or sequence UV/QVA. The number of patients on each treatment does not add up to the total number of patients.
|
|
Infections and infestations
Urinary tract infection
|
0.29%
1/341
Since this is a cross-over design study, all patients were randomized to receive both treatments, either in sequence QVA/UV or sequence UV/QVA. The number of patients on each treatment does not add up to the total number of patients.
|
0.00%
0/340
Since this is a cross-over design study, all patients were randomized to receive both treatments, either in sequence QVA/UV or sequence UV/QVA. The number of patients on each treatment does not add up to the total number of patients.
|
0.28%
1/356
Since this is a cross-over design study, all patients were randomized to receive both treatments, either in sequence QVA/UV or sequence UV/QVA. The number of patients on each treatment does not add up to the total number of patients.
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.29%
1/341
Since this is a cross-over design study, all patients were randomized to receive both treatments, either in sequence QVA/UV or sequence UV/QVA. The number of patients on each treatment does not add up to the total number of patients.
|
0.00%
0/340
Since this is a cross-over design study, all patients were randomized to receive both treatments, either in sequence QVA/UV or sequence UV/QVA. The number of patients on each treatment does not add up to the total number of patients.
|
0.28%
1/356
Since this is a cross-over design study, all patients were randomized to receive both treatments, either in sequence QVA/UV or sequence UV/QVA. The number of patients on each treatment does not add up to the total number of patients.
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.00%
0/341
Since this is a cross-over design study, all patients were randomized to receive both treatments, either in sequence QVA/UV or sequence UV/QVA. The number of patients on each treatment does not add up to the total number of patients.
|
0.29%
1/340
Since this is a cross-over design study, all patients were randomized to receive both treatments, either in sequence QVA/UV or sequence UV/QVA. The number of patients on each treatment does not add up to the total number of patients.
|
0.28%
1/356
Since this is a cross-over design study, all patients were randomized to receive both treatments, either in sequence QVA/UV or sequence UV/QVA. The number of patients on each treatment does not add up to the total number of patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myeloid leukaemia
|
0.00%
0/341
Since this is a cross-over design study, all patients were randomized to receive both treatments, either in sequence QVA/UV or sequence UV/QVA. The number of patients on each treatment does not add up to the total number of patients.
|
0.29%
1/340
Since this is a cross-over design study, all patients were randomized to receive both treatments, either in sequence QVA/UV or sequence UV/QVA. The number of patients on each treatment does not add up to the total number of patients.
|
0.28%
1/356
Since this is a cross-over design study, all patients were randomized to receive both treatments, either in sequence QVA/UV or sequence UV/QVA. The number of patients on each treatment does not add up to the total number of patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.29%
1/341
Since this is a cross-over design study, all patients were randomized to receive both treatments, either in sequence QVA/UV or sequence UV/QVA. The number of patients on each treatment does not add up to the total number of patients.
|
0.00%
0/340
Since this is a cross-over design study, all patients were randomized to receive both treatments, either in sequence QVA/UV or sequence UV/QVA. The number of patients on each treatment does not add up to the total number of patients.
|
0.28%
1/356
Since this is a cross-over design study, all patients were randomized to receive both treatments, either in sequence QVA/UV or sequence UV/QVA. The number of patients on each treatment does not add up to the total number of patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.00%
0/341
Since this is a cross-over design study, all patients were randomized to receive both treatments, either in sequence QVA/UV or sequence UV/QVA. The number of patients on each treatment does not add up to the total number of patients.
|
0.29%
1/340
Since this is a cross-over design study, all patients were randomized to receive both treatments, either in sequence QVA/UV or sequence UV/QVA. The number of patients on each treatment does not add up to the total number of patients.
|
0.28%
1/356
Since this is a cross-over design study, all patients were randomized to receive both treatments, either in sequence QVA/UV or sequence UV/QVA. The number of patients on each treatment does not add up to the total number of patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.00%
0/341
Since this is a cross-over design study, all patients were randomized to receive both treatments, either in sequence QVA/UV or sequence UV/QVA. The number of patients on each treatment does not add up to the total number of patients.
|
0.29%
1/340
Since this is a cross-over design study, all patients were randomized to receive both treatments, either in sequence QVA/UV or sequence UV/QVA. The number of patients on each treatment does not add up to the total number of patients.
|
0.28%
1/356
Since this is a cross-over design study, all patients were randomized to receive both treatments, either in sequence QVA/UV or sequence UV/QVA. The number of patients on each treatment does not add up to the total number of patients.
|
|
Psychiatric disorders
Major depression
|
0.00%
0/341
Since this is a cross-over design study, all patients were randomized to receive both treatments, either in sequence QVA/UV or sequence UV/QVA. The number of patients on each treatment does not add up to the total number of patients.
|
0.29%
1/340
Since this is a cross-over design study, all patients were randomized to receive both treatments, either in sequence QVA/UV or sequence UV/QVA. The number of patients on each treatment does not add up to the total number of patients.
|
0.28%
1/356
Since this is a cross-over design study, all patients were randomized to receive both treatments, either in sequence QVA/UV or sequence UV/QVA. The number of patients on each treatment does not add up to the total number of patients.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.88%
3/341
Since this is a cross-over design study, all patients were randomized to receive both treatments, either in sequence QVA/UV or sequence UV/QVA. The number of patients on each treatment does not add up to the total number of patients.
|
0.59%
2/340
Since this is a cross-over design study, all patients were randomized to receive both treatments, either in sequence QVA/UV or sequence UV/QVA. The number of patients on each treatment does not add up to the total number of patients.
|
1.4%
5/356
Since this is a cross-over design study, all patients were randomized to receive both treatments, either in sequence QVA/UV or sequence UV/QVA. The number of patients on each treatment does not add up to the total number of patients.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
2.1%
7/341
Since this is a cross-over design study, all patients were randomized to receive both treatments, either in sequence QVA/UV or sequence UV/QVA. The number of patients on each treatment does not add up to the total number of patients.
|
1.8%
6/340
Since this is a cross-over design study, all patients were randomized to receive both treatments, either in sequence QVA/UV or sequence UV/QVA. The number of patients on each treatment does not add up to the total number of patients.
|
3.7%
13/356
Since this is a cross-over design study, all patients were randomized to receive both treatments, either in sequence QVA/UV or sequence UV/QVA. The number of patients on each treatment does not add up to the total number of patients.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.29%
1/341
Since this is a cross-over design study, all patients were randomized to receive both treatments, either in sequence QVA/UV or sequence UV/QVA. The number of patients on each treatment does not add up to the total number of patients.
|
0.00%
0/340
Since this is a cross-over design study, all patients were randomized to receive both treatments, either in sequence QVA/UV or sequence UV/QVA. The number of patients on each treatment does not add up to the total number of patients.
|
0.28%
1/356
Since this is a cross-over design study, all patients were randomized to receive both treatments, either in sequence QVA/UV or sequence UV/QVA. The number of patients on each treatment does not add up to the total number of patients.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.59%
2/341
Since this is a cross-over design study, all patients were randomized to receive both treatments, either in sequence QVA/UV or sequence UV/QVA. The number of patients on each treatment does not add up to the total number of patients.
|
0.00%
0/340
Since this is a cross-over design study, all patients were randomized to receive both treatments, either in sequence QVA/UV or sequence UV/QVA. The number of patients on each treatment does not add up to the total number of patients.
|
0.56%
2/356
Since this is a cross-over design study, all patients were randomized to receive both treatments, either in sequence QVA/UV or sequence UV/QVA. The number of patients on each treatment does not add up to the total number of patients.
|
|
Vascular disorders
Deep vein thrombosis
|
0.29%
1/341
Since this is a cross-over design study, all patients were randomized to receive both treatments, either in sequence QVA/UV or sequence UV/QVA. The number of patients on each treatment does not add up to the total number of patients.
|
0.00%
0/340
Since this is a cross-over design study, all patients were randomized to receive both treatments, either in sequence QVA/UV or sequence UV/QVA. The number of patients on each treatment does not add up to the total number of patients.
|
0.28%
1/356
Since this is a cross-over design study, all patients were randomized to receive both treatments, either in sequence QVA/UV or sequence UV/QVA. The number of patients on each treatment does not add up to the total number of patients.
|
Other adverse events
| Measure |
QVA149
n=341 participants at risk
Participants received QVA149 27.5/12.5 ug via inhalation twice daily (b.i.d.) for 12 weeks.
|
Umeclidinium/Vilanterol
n=340 participants at risk
Participants received Umeclidinium/vilanterol 62.5/25 ug via inhalation b.i.d. for 12 weeks.
|
All Patients
n=356 participants at risk
All Patients
|
|---|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
5.6%
19/341
Since this is a cross-over design study, all patients were randomized to receive both treatments, either in sequence QVA/UV or sequence UV/QVA. The number of patients on each treatment does not add up to the total number of patients.
|
3.5%
12/340
Since this is a cross-over design study, all patients were randomized to receive both treatments, either in sequence QVA/UV or sequence UV/QVA. The number of patients on each treatment does not add up to the total number of patients.
|
7.9%
28/356
Since this is a cross-over design study, all patients were randomized to receive both treatments, either in sequence QVA/UV or sequence UV/QVA. The number of patients on each treatment does not add up to the total number of patients.
|
|
Infections and infestations
Sinusitis
|
1.2%
4/341
Since this is a cross-over design study, all patients were randomized to receive both treatments, either in sequence QVA/UV or sequence UV/QVA. The number of patients on each treatment does not add up to the total number of patients.
|
0.59%
2/340
Since this is a cross-over design study, all patients were randomized to receive both treatments, either in sequence QVA/UV or sequence UV/QVA. The number of patients on each treatment does not add up to the total number of patients.
|
1.4%
5/356
Since this is a cross-over design study, all patients were randomized to receive both treatments, either in sequence QVA/UV or sequence UV/QVA. The number of patients on each treatment does not add up to the total number of patients.
|
|
Infections and infestations
Upper respiratory tract infection
|
1.8%
6/341
Since this is a cross-over design study, all patients were randomized to receive both treatments, either in sequence QVA/UV or sequence UV/QVA. The number of patients on each treatment does not add up to the total number of patients.
|
3.2%
11/340
Since this is a cross-over design study, all patients were randomized to receive both treatments, either in sequence QVA/UV or sequence UV/QVA. The number of patients on each treatment does not add up to the total number of patients.
|
4.5%
16/356
Since this is a cross-over design study, all patients were randomized to receive both treatments, either in sequence QVA/UV or sequence UV/QVA. The number of patients on each treatment does not add up to the total number of patients.
|
|
Infections and infestations
Upper respiratory tract infection bacterial
|
0.29%
1/341
Since this is a cross-over design study, all patients were randomized to receive both treatments, either in sequence QVA/UV or sequence UV/QVA. The number of patients on each treatment does not add up to the total number of patients.
|
0.88%
3/340
Since this is a cross-over design study, all patients were randomized to receive both treatments, either in sequence QVA/UV or sequence UV/QVA. The number of patients on each treatment does not add up to the total number of patients.
|
1.1%
4/356
Since this is a cross-over design study, all patients were randomized to receive both treatments, either in sequence QVA/UV or sequence UV/QVA. The number of patients on each treatment does not add up to the total number of patients.
|
|
Infections and infestations
Urinary tract infection
|
0.29%
1/341
Since this is a cross-over design study, all patients were randomized to receive both treatments, either in sequence QVA/UV or sequence UV/QVA. The number of patients on each treatment does not add up to the total number of patients.
|
1.2%
4/340
Since this is a cross-over design study, all patients were randomized to receive both treatments, either in sequence QVA/UV or sequence UV/QVA. The number of patients on each treatment does not add up to the total number of patients.
|
1.4%
5/356
Since this is a cross-over design study, all patients were randomized to receive both treatments, either in sequence QVA/UV or sequence UV/QVA. The number of patients on each treatment does not add up to the total number of patients.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.88%
3/341
Since this is a cross-over design study, all patients were randomized to receive both treatments, either in sequence QVA/UV or sequence UV/QVA. The number of patients on each treatment does not add up to the total number of patients.
|
0.88%
3/340
Since this is a cross-over design study, all patients were randomized to receive both treatments, either in sequence QVA/UV or sequence UV/QVA. The number of patients on each treatment does not add up to the total number of patients.
|
1.7%
6/356
Since this is a cross-over design study, all patients were randomized to receive both treatments, either in sequence QVA/UV or sequence UV/QVA. The number of patients on each treatment does not add up to the total number of patients.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.29%
1/341
Since this is a cross-over design study, all patients were randomized to receive both treatments, either in sequence QVA/UV or sequence UV/QVA. The number of patients on each treatment does not add up to the total number of patients.
|
0.88%
3/340
Since this is a cross-over design study, all patients were randomized to receive both treatments, either in sequence QVA/UV or sequence UV/QVA. The number of patients on each treatment does not add up to the total number of patients.
|
1.1%
4/356
Since this is a cross-over design study, all patients were randomized to receive both treatments, either in sequence QVA/UV or sequence UV/QVA. The number of patients on each treatment does not add up to the total number of patients.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.29%
1/341
Since this is a cross-over design study, all patients were randomized to receive both treatments, either in sequence QVA/UV or sequence UV/QVA. The number of patients on each treatment does not add up to the total number of patients.
|
0.88%
3/340
Since this is a cross-over design study, all patients were randomized to receive both treatments, either in sequence QVA/UV or sequence UV/QVA. The number of patients on each treatment does not add up to the total number of patients.
|
1.1%
4/356
Since this is a cross-over design study, all patients were randomized to receive both treatments, either in sequence QVA/UV or sequence UV/QVA. The number of patients on each treatment does not add up to the total number of patients.
|
|
Gastrointestinal disorders
Nausea
|
0.88%
3/341
Since this is a cross-over design study, all patients were randomized to receive both treatments, either in sequence QVA/UV or sequence UV/QVA. The number of patients on each treatment does not add up to the total number of patients.
|
0.29%
1/340
Since this is a cross-over design study, all patients were randomized to receive both treatments, either in sequence QVA/UV or sequence UV/QVA. The number of patients on each treatment does not add up to the total number of patients.
|
1.1%
4/356
Since this is a cross-over design study, all patients were randomized to receive both treatments, either in sequence QVA/UV or sequence UV/QVA. The number of patients on each treatment does not add up to the total number of patients.
|
|
Gastrointestinal disorders
Vomiting
|
0.29%
1/341
Since this is a cross-over design study, all patients were randomized to receive both treatments, either in sequence QVA/UV or sequence UV/QVA. The number of patients on each treatment does not add up to the total number of patients.
|
0.88%
3/340
Since this is a cross-over design study, all patients were randomized to receive both treatments, either in sequence QVA/UV or sequence UV/QVA. The number of patients on each treatment does not add up to the total number of patients.
|
1.1%
4/356
Since this is a cross-over design study, all patients were randomized to receive both treatments, either in sequence QVA/UV or sequence UV/QVA. The number of patients on each treatment does not add up to the total number of patients.
|
|
General disorders
Fatigue
|
0.59%
2/341
Since this is a cross-over design study, all patients were randomized to receive both treatments, either in sequence QVA/UV or sequence UV/QVA. The number of patients on each treatment does not add up to the total number of patients.
|
0.59%
2/340
Since this is a cross-over design study, all patients were randomized to receive both treatments, either in sequence QVA/UV or sequence UV/QVA. The number of patients on each treatment does not add up to the total number of patients.
|
1.1%
4/356
Since this is a cross-over design study, all patients were randomized to receive both treatments, either in sequence QVA/UV or sequence UV/QVA. The number of patients on each treatment does not add up to the total number of patients.
|
|
Infections and infestations
Bronchitis
|
1.5%
5/341
Since this is a cross-over design study, all patients were randomized to receive both treatments, either in sequence QVA/UV or sequence UV/QVA. The number of patients on each treatment does not add up to the total number of patients.
|
3.2%
11/340
Since this is a cross-over design study, all patients were randomized to receive both treatments, either in sequence QVA/UV or sequence UV/QVA. The number of patients on each treatment does not add up to the total number of patients.
|
4.2%
15/356
Since this is a cross-over design study, all patients were randomized to receive both treatments, either in sequence QVA/UV or sequence UV/QVA. The number of patients on each treatment does not add up to the total number of patients.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
1.2%
4/341
Since this is a cross-over design study, all patients were randomized to receive both treatments, either in sequence QVA/UV or sequence UV/QVA. The number of patients on each treatment does not add up to the total number of patients.
|
1.8%
6/340
Since this is a cross-over design study, all patients were randomized to receive both treatments, either in sequence QVA/UV or sequence UV/QVA. The number of patients on each treatment does not add up to the total number of patients.
|
2.8%
10/356
Since this is a cross-over design study, all patients were randomized to receive both treatments, either in sequence QVA/UV or sequence UV/QVA. The number of patients on each treatment does not add up to the total number of patients.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.88%
3/341
Since this is a cross-over design study, all patients were randomized to receive both treatments, either in sequence QVA/UV or sequence UV/QVA. The number of patients on each treatment does not add up to the total number of patients.
|
0.29%
1/340
Since this is a cross-over design study, all patients were randomized to receive both treatments, either in sequence QVA/UV or sequence UV/QVA. The number of patients on each treatment does not add up to the total number of patients.
|
1.1%
4/356
Since this is a cross-over design study, all patients were randomized to receive both treatments, either in sequence QVA/UV or sequence UV/QVA. The number of patients on each treatment does not add up to the total number of patients.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.88%
3/341
Since this is a cross-over design study, all patients were randomized to receive both treatments, either in sequence QVA/UV or sequence UV/QVA. The number of patients on each treatment does not add up to the total number of patients.
|
1.2%
4/340
Since this is a cross-over design study, all patients were randomized to receive both treatments, either in sequence QVA/UV or sequence UV/QVA. The number of patients on each treatment does not add up to the total number of patients.
|
2.0%
7/356
Since this is a cross-over design study, all patients were randomized to receive both treatments, either in sequence QVA/UV or sequence UV/QVA. The number of patients on each treatment does not add up to the total number of patients.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/341
Since this is a cross-over design study, all patients were randomized to receive both treatments, either in sequence QVA/UV or sequence UV/QVA. The number of patients on each treatment does not add up to the total number of patients.
|
1.2%
4/340
Since this is a cross-over design study, all patients were randomized to receive both treatments, either in sequence QVA/UV or sequence UV/QVA. The number of patients on each treatment does not add up to the total number of patients.
|
1.1%
4/356
Since this is a cross-over design study, all patients were randomized to receive both treatments, either in sequence QVA/UV or sequence UV/QVA. The number of patients on each treatment does not add up to the total number of patients.
|
|
Nervous system disorders
Headache
|
0.88%
3/341
Since this is a cross-over design study, all patients were randomized to receive both treatments, either in sequence QVA/UV or sequence UV/QVA. The number of patients on each treatment does not add up to the total number of patients.
|
1.5%
5/340
Since this is a cross-over design study, all patients were randomized to receive both treatments, either in sequence QVA/UV or sequence UV/QVA. The number of patients on each treatment does not add up to the total number of patients.
|
2.2%
8/356
Since this is a cross-over design study, all patients were randomized to receive both treatments, either in sequence QVA/UV or sequence UV/QVA. The number of patients on each treatment does not add up to the total number of patients.
|
|
Psychiatric disorders
Anxiety
|
0.59%
2/341
Since this is a cross-over design study, all patients were randomized to receive both treatments, either in sequence QVA/UV or sequence UV/QVA. The number of patients on each treatment does not add up to the total number of patients.
|
0.88%
3/340
Since this is a cross-over design study, all patients were randomized to receive both treatments, either in sequence QVA/UV or sequence UV/QVA. The number of patients on each treatment does not add up to the total number of patients.
|
1.4%
5/356
Since this is a cross-over design study, all patients were randomized to receive both treatments, either in sequence QVA/UV or sequence UV/QVA. The number of patients on each treatment does not add up to the total number of patients.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
10.6%
36/341
Since this is a cross-over design study, all patients were randomized to receive both treatments, either in sequence QVA/UV or sequence UV/QVA. The number of patients on each treatment does not add up to the total number of patients.
|
14.7%
50/340
Since this is a cross-over design study, all patients were randomized to receive both treatments, either in sequence QVA/UV or sequence UV/QVA. The number of patients on each treatment does not add up to the total number of patients.
|
21.3%
76/356
Since this is a cross-over design study, all patients were randomized to receive both treatments, either in sequence QVA/UV or sequence UV/QVA. The number of patients on each treatment does not add up to the total number of patients.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.8%
6/341
Since this is a cross-over design study, all patients were randomized to receive both treatments, either in sequence QVA/UV or sequence UV/QVA. The number of patients on each treatment does not add up to the total number of patients.
|
1.5%
5/340
Since this is a cross-over design study, all patients were randomized to receive both treatments, either in sequence QVA/UV or sequence UV/QVA. The number of patients on each treatment does not add up to the total number of patients.
|
2.8%
10/356
Since this is a cross-over design study, all patients were randomized to receive both treatments, either in sequence QVA/UV or sequence UV/QVA. The number of patients on each treatment does not add up to the total number of patients.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
2.1%
7/341
Since this is a cross-over design study, all patients were randomized to receive both treatments, either in sequence QVA/UV or sequence UV/QVA. The number of patients on each treatment does not add up to the total number of patients.
|
2.4%
8/340
Since this is a cross-over design study, all patients were randomized to receive both treatments, either in sequence QVA/UV or sequence UV/QVA. The number of patients on each treatment does not add up to the total number of patients.
|
3.9%
14/356
Since this is a cross-over design study, all patients were randomized to receive both treatments, either in sequence QVA/UV or sequence UV/QVA. The number of patients on each treatment does not add up to the total number of patients.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.59%
2/341
Since this is a cross-over design study, all patients were randomized to receive both treatments, either in sequence QVA/UV or sequence UV/QVA. The number of patients on each treatment does not add up to the total number of patients.
|
0.88%
3/340
Since this is a cross-over design study, all patients were randomized to receive both treatments, either in sequence QVA/UV or sequence UV/QVA. The number of patients on each treatment does not add up to the total number of patients.
|
1.4%
5/356
Since this is a cross-over design study, all patients were randomized to receive both treatments, either in sequence QVA/UV or sequence UV/QVA. The number of patients on each treatment does not add up to the total number of patients.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
2.9%
10/341
Since this is a cross-over design study, all patients were randomized to receive both treatments, either in sequence QVA/UV or sequence UV/QVA. The number of patients on each treatment does not add up to the total number of patients.
|
1.5%
5/340
Since this is a cross-over design study, all patients were randomized to receive both treatments, either in sequence QVA/UV or sequence UV/QVA. The number of patients on each treatment does not add up to the total number of patients.
|
3.9%
14/356
Since this is a cross-over design study, all patients were randomized to receive both treatments, either in sequence QVA/UV or sequence UV/QVA. The number of patients on each treatment does not add up to the total number of patients.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.88%
3/341
Since this is a cross-over design study, all patients were randomized to receive both treatments, either in sequence QVA/UV or sequence UV/QVA. The number of patients on each treatment does not add up to the total number of patients.
|
0.29%
1/340
Since this is a cross-over design study, all patients were randomized to receive both treatments, either in sequence QVA/UV or sequence UV/QVA. The number of patients on each treatment does not add up to the total number of patients.
|
1.1%
4/356
Since this is a cross-over design study, all patients were randomized to receive both treatments, either in sequence QVA/UV or sequence UV/QVA. The number of patients on each treatment does not add up to the total number of patients.
|
|
Vascular disorders
Hypertension
|
0.88%
3/341
Since this is a cross-over design study, all patients were randomized to receive both treatments, either in sequence QVA/UV or sequence UV/QVA. The number of patients on each treatment does not add up to the total number of patients.
|
0.88%
3/340
Since this is a cross-over design study, all patients were randomized to receive both treatments, either in sequence QVA/UV or sequence UV/QVA. The number of patients on each treatment does not add up to the total number of patients.
|
1.7%
6/356
Since this is a cross-over design study, all patients were randomized to receive both treatments, either in sequence QVA/UV or sequence UV/QVA. The number of patients on each treatment does not add up to the total number of patients.
|
Additional Information
Study Director
Novartis Pharmaceuticals
Phone: 862-778-1873
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