Trial Outcomes & Findings for Efficacy and Safety Study of Indacaterol Maleate/Glycopyrronium Bromide in Chronic Obstructive Pulmonary Disease (COPD) Patients. (NCT NCT02487498)
NCT ID: NCT02487498
Last Updated: 2018-04-02
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
355 participants
Primary outcome timeframe
baseline, 0 to 24 hours post-dose at week 12
Results posted on
2018-04-02
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: Period 1
STARTED
|
178
|
177
|
|
Period: Period 1
COMPLETED
|
172
|
166
|
|
Period: Period 1
NOT COMPLETED
|
6
|
11
|
|
Period: Washout
STARTED
|
172
|
166
|
|
Period: Washout
COMPLETED
|
170
|
159
|
|
Period: Washout
NOT COMPLETED
|
2
|
7
|
|
Period: Period 2
STARTED
|
170
|
159
|
|
Period: Period 2
COMPLETED
|
164
|
154
|
|
Period: Period 2
NOT COMPLETED
|
6
|
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: Period 1
Adverse Event
|
2
|
4
|
|
Period: Period 1
Subject/guardian decision
|
2
|
4
|
|
Period: Period 1
Lost to Follow-up
|
0
|
2
|
|
Period: Period 1
Lack of Efficacy
|
1
|
0
|
|
Period: Period 1
Physician Decision
|
0
|
1
|
|
Period: Period 1
Protocol deviation
|
1
|
0
|
|
Period: Washout
Subject/guardian decision
|
0
|
5
|
|
Period: Washout
Lack of Efficacy
|
1
|
1
|
|
Period: Washout
Physician Decision
|
1
|
0
|
|
Period: Washout
Non-compliance with study treatment
|
0
|
1
|
|
Period: Period 2
Adverse Event
|
2
|
2
|
|
Period: Period 2
Subject/guardian decision
|
2
|
1
|
|
Period: Period 2
Lost to Follow-up
|
1
|
1
|
|
Period: Period 2
Death
|
0
|
1
|
|
Period: Period 2
Physician Decision
|
1
|
0
|
Baseline Characteristics
Efficacy and Safety Study of Indacaterol Maleate/Glycopyrronium Bromide in Chronic Obstructive Pulmonary Disease (COPD) Patients.
Baseline characteristics by cohort
| Measure |
Overall Participants
n=355 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
|
63.9 Years
STANDARD_DEVIATION 8.30 • n=5 Participants
|
|
Sex: Female, Male
Female
|
163 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
192 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 |
First QVA149, Then Umeclidinium/Vilanterol
n=319 Participants
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
n=326 Participants
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.
|
|---|---|---|
|
Change From Baseline in Forced Expiratory Volume (FEV1) Area Under the Curve (AUC) 0-24h
|
0.1846 Liters
Standard Error 0.01193
|
0.2028 Liters
Standard Error 0.01188
|
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 |
First QVA149, Then Umeclidinium/Vilanterol
n=319 Participants
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
n=326 Participants
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.
|
|---|---|---|
|
Change From Baseline in Forced Expiratory Volume (FEV1) Area Under the Curve (AUC) 0-24h
|
0.1846 Liters
Standard Error 0.01193
|
0.2028 Liters
Standard Error 0.01188
|
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 |
First QVA149, Then Umeclidinium/Vilanterol
n=312 Participants
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
n=312 Participants
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.
|
|---|---|---|
|
Superiority of QVA149 Compared to Umeclidinium/Vilanterol in Terms of Change From Baseline in Trough FEV1 (Mean of 23h 15 Minutes and 23 h 45 Minutes Post Previous Morning Dose)
|
0.1676 Liters
Standard Error 0.01112
|
0.1767 Liters
Standard Error 0.01111
|
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 |
First QVA149, Then Umeclidinium/Vilanterol
n=317 Participants
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
n=323 Participants
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.
|
|---|---|---|
|
Change From Baseline in FEV1 AUC 12-24h
|
0.1625 Liters
Standard Error 0.01216
|
0.1539 Liters
Standard Error 0.01210
|
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 |
First QVA149, Then Umeclidinium/Vilanterol
n=319 Participants
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
n=326 Participants
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.
|
|---|---|---|
|
Change From Baseline in FEV1 AUC 0-12h
|
0.2077 Liters
Standard Error 0.01082
|
0.2496 Liters
Standard Error 0.01075
|
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 |
First QVA149, Then Umeclidinium/Vilanterol
n=337 Participants
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
n=347 Participants
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.
|
|---|---|---|
|
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
|
0.2663 Liter
Standard Error 0.01082
|
0.2938 Liter
Standard Error 0.01077
|
|
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
|
0.1970 Liter
Standard Error 0.01132
|
0.2519 Liter
Standard Error 0.01123
|
|
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
|
0.1513 Liter
Standard Error 0.01143
|
0.2015 Liter
Standard Error 0.01132
|
|
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
|
0.2120 Liter
Standard Error 0.01292
|
0.1842 Liter
Standard Error 0.01285
|
|
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
|
0.1383 Liter
Standard Error 0.01292
|
0.1340 Liter
Standard Error 0.01287
|
|
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
|
0.1374 Liter
Standard Error 0.01197
|
0.1445 Liter
Standard Error 0.01190
|
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 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 |
First QVA149, Then Umeclidinium/Vilanterol
n=319 Participants
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
n=326 Participants
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.
|
|---|---|---|
|
QVA149 Compared to Umeclidinium/Vilanterol in Terms of Change From Baseline in Pre-dose Trough FEV1 (Mean of 15 Minutes and 45 Minutes Pre Morning Dose)
|
0.1827 Liters
Standard Error 0.01183
|
0.2043 Liters
Standard Error 0.01177
|
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 |
First QVA149, Then Umeclidinium/Vilanterol
n=337 Participants
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
n=347 Participants
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.
|
|---|---|---|
|
QVA149 Compared to Umeclidinium/Vilanterol in Terms of Change From Baseline in FEV1 at Any Time Point
Day 1, 5 minutes
|
0.1134 Liters
Standard Error 0.00996
|
0.1117 Liters
Standard Error 0.00984
|
|
QVA149 Compared to Umeclidinium/Vilanterol in Terms of Change From Baseline in FEV1 at Any Time Point
Day 1, 15 minutes
|
0.1448 Liters
Standard Error 0.01081
|
0.1591 Liters
Standard Error 0.01053
|
|
QVA149 Compared to Umeclidinium/Vilanterol in Terms of Change From Baseline in FEV1 at Any Time Point
Day 1, 30 minutes
|
0.1630 Liters
Standard Error 0.01080
|
0.1836 Liters
Standard Error 0.01071
|
|
QVA149 Compared to Umeclidinium/Vilanterol in Terms of Change From Baseline in FEV1 at Any Time Point
Day 1, 1 hour
|
0.1742 Liters
Standard Error 0.01133
|
0.2000 Liters
Standard Error 0.01121
|
|
QVA149 Compared to Umeclidinium/Vilanterol in Terms of Change From Baseline in FEV1 at Any Time Point
Day 1, 2 hours
|
0.1723 Liters
Standard Error 0.01152
|
0.2138 Liters
Standard Error 0.01136
|
|
QVA149 Compared to Umeclidinium/Vilanterol in Terms of Change From Baseline in FEV1 at Any Time Point
Day 1, 4 hours
|
0.1487 Liters
Standard Error 0.01179
|
0.2168 Liters
Standard Error 0.01165
|
|
QVA149 Compared to Umeclidinium/Vilanterol in Terms of Change From Baseline in FEV1 at Any Time Point
Day 1, 8 hours
|
0.0908 Liters
Standard Error 0.01160
|
0.1781 Liters
Standard Error 0.01145
|
|
QVA149 Compared to Umeclidinium/Vilanterol in Terms of Change From Baseline in FEV1 at Any Time Point
Day 1, 11 hours 55 minutes
|
0.0521 Liters
Standard Error 0.01203
|
0.1537 Liters
Standard Error 0.01185
|
|
QVA149 Compared to Umeclidinium/Vilanterol in Terms of Change From Baseline in FEV1 at Any Time Point
Day 1, 23 hours 15 minutes
|
0.1422 Liters
Standard Error 0.01109
|
0.1573 Liters
Standard Error 0.01099
|
|
QVA149 Compared to Umeclidinium/Vilanterol in Terms of Change From Baseline in FEV1 at Any Time Point
Day 1, 23 hours 45 minutes
|
0.1702 Liters
Standard Error 0.01156
|
0.1821 Liters
Standard Error 0.01145
|
|
QVA149 Compared to Umeclidinium/Vilanterol in Terms of Change From Baseline in FEV1 at Any Time Point
Week 6, -45 minutes
|
0.1819 Liters
Standard Error 0.01197
|
0.2071 Liters
Standard Error 0.01188
|
|
QVA149 Compared to Umeclidinium/Vilanterol in Terms of Change From Baseline in FEV1 at Any Time Point
Week 6, -15 minutes
|
0.2111 Liters
Standard Error 0.01225
|
0.2343 Liters
Standard Error 0.01214
|
|
QVA149 Compared to Umeclidinium/Vilanterol in Terms of Change From Baseline in FEV1 at Any Time Point
Week 12, -45 minutes
|
0.1750 Liters
Standard Error 0.01195
|
0.1957 Liters
Standard Error 0.01191
|
|
QVA149 Compared to Umeclidinium/Vilanterol in Terms of Change From Baseline in FEV1 at Any Time Point
Week 12, -15 minutes
|
0.1914 Liters
Standard Error 0.01217
|
0.2112 Liters
Standard Error 0.01214
|
|
QVA149 Compared to Umeclidinium/Vilanterol in Terms of Change From Baseline in FEV1 at Any Time Point
Week 12, 5 minutes
|
0.2421 Liters
Standard Error 0.01020
|
0.2563 Liters
Standard Error 0.01015
|
|
QVA149 Compared to Umeclidinium/Vilanterol in Terms of Change From Baseline in FEV1 at Any Time Point
Week 12, 15 minutes
|
0.2681 Liters
Standard Error 0.01086
|
0.2865 Liters
Standard Error 0.01084
|
|
QVA149 Compared to Umeclidinium/Vilanterol in Terms of Change From Baseline in FEV1 at Any Time Point
Week 12, 30 minutes
|
0.2819 Liters
Standard Error 0.01097
|
0.2940 Liters
Standard Error 0.01090
|
|
QVA149 Compared to Umeclidinium/Vilanterol in Terms of Change From Baseline in FEV1 at Any Time Point
Week 12, 1 hour
|
0.2919 Liters
Standard Error 0.01149
|
0.3053 Liters
Standard Error 0.01141
|
|
QVA149 Compared to Umeclidinium/Vilanterol in Terms of Change From Baseline in FEV1 at Any Time Point
Week 12, 2 hours
|
0.2740 Liters
Standard Error 0.01168
|
0.2994 Liters
Standard Error 0.01158
|
|
QVA149 Compared to Umeclidinium/Vilanterol in Terms of Change From Baseline in FEV1 at Any Time Point
Week 12, 4 hours
|
0.2316 Liters
Standard Error 0.01192
|
0.2823 Liters
Standard Error 0.01185
|
|
QVA149 Compared to Umeclidinium/Vilanterol in Terms of Change From Baseline in FEV1 at Any Time Point
Week 12, 8 hours
|
0.1631 Liters
Standard Error 0.01176
|
0.2201 Liters
Standard Error 0.01167
|
|
QVA149 Compared to Umeclidinium/Vilanterol in Terms of Change From Baseline in FEV1 at Any Time Point
Week 12, 11 hours 55 minutes
|
0.1320 Liters
Standard Error 0.01236
|
0.1812 Liters
Standard Error 0.01193
|
|
QVA149 Compared to Umeclidinium/Vilanterol in Terms of Change From Baseline in FEV1 at Any Time Point
Week 12, 12 hours 5 minutes
|
0.1974 Liters
Standard Error 0.01375
|
0.1893 Liters
Standard Error 0.01364
|
|
QVA149 Compared to Umeclidinium/Vilanterol in Terms of Change From Baseline in FEV1 at Any Time Point
Week 12, 12 hours 15 minutes
|
0.2107 Liters
Standard Error 0.01375
|
0.1959 Liters
Standard Error 0.01368
|
|
QVA149 Compared to Umeclidinium/Vilanterol in Terms of Change From Baseline in FEV1 at Any Time Point
Week 12, 12 hours 30 minutes
|
0.2296 Liters
Standard Error 0.01355
|
0.1934 Liters
Standard Error 0.01350
|
|
QVA149 Compared to Umeclidinium/Vilanterol in Terms of Change From Baseline in FEV1 at Any Time Point
Week 12, 13 hours
|
0.2341 Liters
Standard Error 0.01376
|
0.1953 Liters
Standard Error 0.01364
|
|
QVA149 Compared to Umeclidinium/Vilanterol in Terms of Change From Baseline in FEV1 at Any Time Point
Week 12, 14 hours
|
0.2308 Liters
Standard Error 0.01372
|
0.1966 Liters
Standard Error 0.01357
|
|
QVA149 Compared to Umeclidinium/Vilanterol in Terms of Change From Baseline in FEV1 at Any Time Point
Week 12, 16 hours
|
0.1705 Liters
Standard Error 0.01382
|
0.1582 Liters
Standard Error 0.01381
|
|
QVA149 Compared to Umeclidinium/Vilanterol in Terms of Change From Baseline in FEV1 at Any Time Point
Week 12, 20 hours
|
0.1078 Liters
Standard Error 0.01338
|
0.1158 Liters
Standard Error 0.01338
|
|
QVA149 Compared to Umeclidinium/Vilanterol in Terms of Change From Baseline in FEV1 at Any Time Point
Week 12, 23 hours 15 minutes
|
0.1573 Liters
Standard Error 0.01117
|
0.1648 Liters
Standard Error 0.01115
|
|
QVA149 Compared to Umeclidinium/Vilanterol in Terms of Change From Baseline in FEV1 at Any Time Point
Week 12, 23 hours 45 minutes
|
0.1798 Liters
Standard Error 0.01163
|
0.1892 Liters
Standard Error 0.01167
|
SECONDARY outcome
Timeframe: Day 1 (5min, 15min, 30 min, 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 |
First QVA149, Then Umeclidinium/Vilanterol
n=337 Participants
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
n=347 Participants
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.
|
|---|---|---|
|
QVA149 Compared to Umeclidinium/Vilanterol in Terms of Change From Baseline in Forced Vital Capacity (FVC) at Any Time Point
Day 1, 5 minutes
|
0.1994 Liters
Standard Error 0.01672
|
0.2054 Liters
Standard Error 0.01655
|
|
QVA149 Compared to Umeclidinium/Vilanterol in Terms of Change From Baseline in Forced Vital Capacity (FVC) at Any Time Point
Day 1, 15 minutes
|
0.2454 Liters
Standard Error 0.01764
|
0.2589 Liters
Standard Error 0.01724
|
|
QVA149 Compared to Umeclidinium/Vilanterol in Terms of Change From Baseline in Forced Vital Capacity (FVC) at Any Time Point
Day 1, 30 minutes
|
0.2734 Liters
Standard Error 0.01806
|
0.3028 Liters
Standard Error 0.01792
|
|
QVA149 Compared to Umeclidinium/Vilanterol in Terms of Change From Baseline in Forced Vital Capacity (FVC) at Any Time Point
Day 1, 1 hour
|
0.2841 Liters
Standard Error 0.01937
|
0.3136 Liters
Standard Error 0.01917
|
|
QVA149 Compared to Umeclidinium/Vilanterol in Terms of Change From Baseline in Forced Vital Capacity (FVC) at Any Time Point
Day 1, 2 hours
|
0.2708 Liters
Standard Error 0.01928
|
0.3334 Liters
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, 4 hours
|
0.2333 Liters
Standard Error 0.01914
|
0.3405 Liters
Standard Error 0.01892
|
|
QVA149 Compared to Umeclidinium/Vilanterol in Terms of Change From Baseline in Forced Vital Capacity (FVC) at Any Time Point
Day 1, 8 hours
|
0.1728 Liters
Standard Error 0.01923
|
0.3067 Liters
Standard Error 0.01900
|
|
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
|
0.1291 Liters
Standard Error 0.01971
|
0.2654 Liters
Standard Error 0.01944
|
|
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
|
0.2387 Liters
Standard Error 0.01789
|
0.2363 Liters
Standard Error 0.01775
|
|
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
|
0.2821 Liters
Standard Error 0.01886
|
0.2940 Liters
Standard Error 0.01868
|
|
QVA149 Compared to Umeclidinium/Vilanterol in Terms of Change From Baseline in Forced Vital Capacity (FVC) at Any Time Point
Week 6, -45 minutes
|
0.2666 Liters
Standard Error 0.01958
|
0.3045 Liters
Standard Error 0.01942
|
|
QVA149 Compared to Umeclidinium/Vilanterol in Terms of Change From Baseline in Forced Vital Capacity (FVC) at Any Time Point
Week 6, -15 minutes
|
0.2860 Liters
Standard Error 0.01963
|
0.3372 Liters
Standard Error 0.01943
|
|
QVA149 Compared to Umeclidinium/Vilanterol in Terms of Change From Baseline in Forced Vital Capacity (FVC) at Any Time Point
Week 12, -45 minutes
|
0.2264 Liters
Standard Error 0.01956
|
0.2737 Liters
Standard Error 0.01947
|
|
QVA149 Compared to Umeclidinium/Vilanterol in Terms of Change From Baseline in Forced Vital Capacity (FVC) at Any Time Point
Week 12, -15 minutes
|
0.2468 Liters
Standard Error 0.01949
|
0.2844 Liters
Standard Error 0.01943
|
|
QVA149 Compared to Umeclidinium/Vilanterol in Terms of Change From Baseline in Forced Vital Capacity (FVC) at Any Time Point
Week 12, 5 minutes
|
0.3386 Liters
Standard Error 0.01711
|
0.3489 Liters
Standard Error 0.01701
|
|
QVA149 Compared to Umeclidinium/Vilanterol in Terms of Change From Baseline in Forced Vital Capacity (FVC) at Any Time Point
Week 12, 15 minutes
|
0.3616 Liters
Standard Error 0.01771
|
0.3811 Liters
Standard Error 0.01768
|
|
QVA149 Compared to Umeclidinium/Vilanterol in Terms of Change From Baseline in Forced Vital Capacity (FVC) at Any Time Point
Week 12, 30 minutes
|
0.3796 Liters
Standard Error 0.01830
|
0.4019 Liters
Standard Error 0.01821
|
|
QVA149 Compared to Umeclidinium/Vilanterol in Terms of Change From Baseline in Forced Vital Capacity (FVC) at Any Time Point
Week 12, 1 hour
|
0.3935 Liters
Standard Error 0.01962
|
0.4085 Liters
Standard Error 0.01949
|
|
QVA149 Compared to Umeclidinium/Vilanterol in Terms of Change From Baseline in Forced Vital Capacity (FVC) at Any Time Point
Week 12, 2 hours
|
0.3708 Liters
Standard Error 0.01953
|
0.4050 Liters
Standard Error 0.01937
|
|
QVA149 Compared to Umeclidinium/Vilanterol in Terms of Change From Baseline in Forced Vital Capacity (FVC) at Any Time Point
Week 12, 4 hours
|
0.3261 Liters
Standard Error 0.01933
|
0.3845 Liters
Standard Error 0.01924
|
|
QVA149 Compared to Umeclidinium/Vilanterol in Terms of Change From Baseline in Forced Vital Capacity (FVC) at Any Time Point
Week 12, 8 hours
|
0.2259 Liters
Standard Error 0.01950
|
0.3152 Liters
Standard Error 0.01936
|
|
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
|
0.1900 Liters
Standard Error 0.02023
|
0.2749 Liters
Standard Error 0.01956
|
|
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
|
0.2817 Liters
Standard Error 0.02157
|
0.2711 Liters
Standard Error 0.02141
|
|
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
|
0.3010 Liters
Standard Error 0.02177
|
0.2762 Liters
Standard Error 0.02165
|
|
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
|
0.3279 Liters
Standard Error 0.02155
|
0.2786 Liters
Standard Error 0.02146
|
|
QVA149 Compared to Umeclidinium/Vilanterol in Terms of Change From Baseline in Forced Vital Capacity (FVC) at Any Time Point
Week 12, 13 hours
|
0.3381 Liters
Standard Error 0.02210
|
0.2909 Liters
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, 14 hours
|
0.3445 Liters
Standard Error 0.02233
|
0.2984 Liters
Standard Error 0.02208
|
|
QVA149 Compared to Umeclidinium/Vilanterol in Terms of Change From Baseline in Forced Vital Capacity (FVC) at Any Time Point
Week 12, 16 hours
|
0.2496 Liters
Standard Error 0.02191
|
0.2514 Liters
Standard Error 0.02188
|
|
QVA149 Compared to Umeclidinium/Vilanterol in Terms of Change From Baseline in Forced Vital Capacity (FVC) at Any Time Point
Week 12, 20 hours
|
0.1600 Liters
Standard Error 0.02168
|
0.1845 Liters
Standard Error 0.02169
|
|
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
|
0.2026 Liters
Standard Error 0.01802
|
0.2251 Liters
Standard Error 0.01800
|
|
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
|
0.2415 Liters
Standard Error 0.01897
|
0.2662 Liters
Standard Error 0.01903
|
Adverse Events
QVA 27.5/12.5 Bid
Serious events: 17 serious events
Other events: 78 other events
Deaths: 0 deaths
U/V 62.5/25 od
Serious events: 10 serious events
Other events: 89 other events
Deaths: 0 deaths
All Patients
Serious events: 26 serious events
Other events: 140 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
QVA 27.5/12.5 Bid
n=337 participants at risk
QVA149 capsules for inhalation, delivered via QVA149 SDDPI
|
U/V 62.5/25 od
n=347 participants at risk
Umeclidinium/vilanterol for inhalation, delivered via ELLIPTA® inhaler
|
All Patients
n=355 participants at risk
All Patients
|
|---|---|---|---|
|
Cardiac disorders
Acute coronary syndrome
|
0.30%
1/337
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%
0/347
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%
1/355
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
|
0.59%
2/337
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%
0/347
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%
2/355
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
Myocardial infarction
|
0.30%
1/337
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%
1/347
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%
2/355
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
Pancreatitis acute
|
0.30%
1/337
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%
0/347
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%
1/355
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%
0/337
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%
1/347
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%
1/355
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
Clostridium difficile infection
|
0.00%
0/337
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%
1/347
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%
1/355
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 urinary tract infection
|
0.30%
1/337
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%
0/347
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%
1/355
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
|
0.00%
0/337
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%
1/347
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%
1/355
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
|
0.30%
1/337
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.
|
0.58%
2/347
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.
|
0.85%
3/355
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 staphylococcal
|
0.30%
1/337
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%
0/347
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%
1/355
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
Hypokalaemia
|
0.00%
0/337
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%
1/347
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%
1/355
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
|
0.30%
1/337
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%
0/347
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%
1/355
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
Rhabdomyolysis
|
0.30%
1/337
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%
0/347
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%
1/355
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
|
0.00%
0/337
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%
1/347
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%
1/355
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)
Breast cancer
|
0.00%
0/337
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%
1/347
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%
1/355
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)
Cervix carcinoma stage iii
|
0.00%
0/337
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%
1/347
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%
1/355
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)
Papillary thyroid cancer
|
0.30%
1/337
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%
0/347
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%
1/355
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 of lung
|
0.30%
1/337
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%
0/347
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%
1/355
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 of the oral cavity
|
0.30%
1/337
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%
0/347
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%
1/355
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)
Tonsil cancer
|
0.00%
0/337
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%
1/347
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%
1/355
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
Encephalopathy
|
0.30%
1/337
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%
0/347
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%
1/355
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
Seizure
|
0.00%
0/337
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%
1/347
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%
1/355
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.
|
|
Renal and urinary disorders
Ureterolithiasis
|
0.30%
1/337
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%
0/347
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%
1/355
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
|
0.30%
1/337
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%
0/347
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%
1/355
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
|
2.4%
8/337
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.
|
0.58%
2/347
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%
10/355
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
|
0.30%
1/337
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%
0/347
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%
1/355
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
Arteriosclerosis
|
0.30%
1/337
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%
0/347
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%
1/355
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
Peripheral artery occlusion
|
0.30%
1/337
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%
0/347
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%
1/355
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
Thrombosis
|
0.30%
1/337
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%
0/347
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%
1/355
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
Vascular insufficiency
|
0.30%
1/337
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%
0/347
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%
1/355
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 |
QVA 27.5/12.5 Bid
n=337 participants at risk
QVA149 capsules for inhalation, delivered via QVA149 SDDPI
|
U/V 62.5/25 od
n=347 participants at risk
Umeclidinium/vilanterol for inhalation, delivered via ELLIPTA® inhaler
|
All Patients
n=355 participants at risk
All Patients
|
|---|---|---|---|
|
Infections and infestations
Upper respiratory tract infection bacterial
|
1.2%
4/337
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%
7/347
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.
|
2.5%
9/355
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
Acute sinusitis
|
0.89%
3/337
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%
1/347
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%
4/355
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
|
3.3%
11/337
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%
6/347
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%
16/355
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
Gastroenteritis viral
|
0.89%
3/337
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%
1/347
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%
4/355
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
|
1.2%
4/337
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.
|
0.86%
3/347
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%
7/355
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
Nasopharyngitis
|
0.89%
3/337
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%
4/347
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%
7/355
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
Oral candidiasis
|
1.2%
4/337
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.
|
0.58%
2/347
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%
6/355
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
|
1.8%
6/337
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%
5/347
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.
|
3.1%
11/355
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
|
1.5%
5/337
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.
|
2.3%
8/347
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%
13/355
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
|
0.89%
3/337
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.
|
2.3%
8/347
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.
|
3.1%
11/355
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
Laceration
|
0.59%
2/337
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.
|
0.58%
2/347
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%
4/355
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
|
0.89%
3/337
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.
|
0.58%
2/347
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%
5/355
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
|
0.59%
2/337
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.
|
0.86%
3/347
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%
4/355
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
|
14.8%
50/337
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%
51/347
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.
|
25.1%
89/355
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
|
0.30%
1/337
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%
7/347
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.
|
2.3%
8/355
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
|
0.89%
3/337
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%
4/347
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%
6/355
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
|
0.30%
1/337
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%
4/347
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%
5/355
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
Productive cough
|
0.89%
3/337
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.
|
0.58%
2/347
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%
4/355
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