Chronic Obstructive Pulmonary Disease
Conditions
Keywords
Chronic Obstructive Pulmonary Disease (COPD)
Brief summary
The purpose of this study is to demonstrate that the efficacy of the combination product QVA149 is similar to the efficacy of the combination product umeclidinium/vilanterol on a pre-specified endpoint of FEV1 AUC0-24h while maintaining an acceptable safety profile.
Interventions
DRUGQVA149
QVA149 capsules for inhalation, delivered via QVA149 single dose dry powder inhaler (SDDPI)
Umeclidinium/vilanterol for inhalation, delivered via ELLIPTA® inhaler
DRUGPlacebo (umeclidinium/vilanterol)
Matching Placebo to umeclidinium/vilanterol for inhalation, delivered via ELLIPTA® inhaler
DRUGPlacebo (QVA149)
Matching Placebo to QVA149 capsules for inhalation, delivered via QVA149 SDDPI
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male or female adults aged ≥40 yrs * Smoking history of at least 10 pack years * Diagnosis of stable Chronic Obstructive Pulmonary Disease (COPD) as classified by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) Guidelines, 2015) * Post-bronchodilator Forced Expiratory Volume in 1 Second (FEV1)\< 80% and ≥ 30% of the predicted normal value and post-bronchodilator FEV1/FVC (forced vital capacity) \<70% * Modified Medical Research Council questionnaire grade of 2 or higher
Exclusion criteria
* Patients who have had a respiratory tract infection within 4 weeks prior to Visit 1 * Patients with concomitant pulmonary disease * Patients with a history of asthma * Any patient with lung cancer or a history of lung cancer * Patients with a history of certain cardiovascular co-morbid conditions * Patients with a known history and diagnosis of alpha-1 antitrypsin deficiency * Patients in the active phase of a supervised pulmonary rehabilitation program * Patients contraindicated for inhaled anticholinergic agents and β2 agonists * Other protocol-defined inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Forced Expiratory Volume (FEV1) Area Under the Curve (AUC) 0-24h | baseline, 0 to 24 hours post-dose at week 12 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Trough FEV1 (Mean of 23h 15 Minutes and 23 h 45 Minutes Post Previous Morning Dose) | baseline, 23 hours 15 minutes and 23 hours 45 minutes post previous morning dose at week 12 | 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 |
| Change From Baseline in FEV1 AUC 12-24h | baseline, 12 hours to 24 hours post-dose at week 12 | 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). |
| Change From Baseline in FEV1 AUC 0-12h | baseline, 0 to 12 hours post-dose at week 12 | 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). |
| Change From Baseline in Forced Expiratory Volume (FEV1) Area Under the Curve (AUC) 0-24h | baseline, 0 to 24 hours post-dose at week 12 | 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. |
| Change From Baseline in Pre-dose Trough FEV1 (Mean of 15 Minutes and 45 Minutes Pre Morning Dose) | baseline, 15 minutes and 45 minutes pre morning dose at week 12 | 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. |
| QVA149 Compared to Umeclidinium/Vilanterol in Terms of Change From Baseline in FEV1 at Any Time Point | 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) | FEV1 was measured with spirometry conducted according to internationally accepted standards. |
| QVA149 Compared to Umeclidinium/Vilanterol in Terms of Change From Baseline in Forced Vital Capacity (FVC) at Any Time Point | 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) | FEV1 was measured with spirometry conducted according to internationally accepted standards. |
| Change From Baseline in FEV1 AUC 0-4h, AUC 4-8h, AUC 8-12h, AUC 12-16h, AUC 16-20h and AUC 20-24h | baseline, 12 weeks | 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. |
Countries
United States
Participant flow
Pre-assignment details
Participants were randomized to 1 of 2 sequences in a 1:1 ratio.
Participants by arm
| Arm | Count |
|---|---|
| Overall 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. | 357 |
| Total | 357 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Period 1 | Adverse Event | 5 | 5 |
| Period 1 | Lack of Efficacy | 1 | 0 |
| Period 1 | Lost to Follow-up | 2 | 0 |
| Period 1 | Physician Decision | 0 | 1 |
| Period 1 | Protocol deviation | 3 | 2 |
| Period 1 | Withdrawal by Subject | 2 | 0 |
| Period 2 | Adverse Event | 6 | 2 |
| Period 2 | Lost to Follow-up | 1 | 1 |
| Period 2 | Protocol deviation | 0 | 1 |
| Period 2 | Withdrawal by Subject | 1 | 1 |
| Washout | Adverse Event | 2 | 2 |
| Washout | Lost to Follow-up | 0 | 2 |
| Washout | Withdrawal by Subject | 1 | 4 |
Baseline characteristics
| Characteristic | Overall Participants |
|---|---|
| Age, Continuous | 64.1 Years STANDARD_DEVIATION 8.21 |
| Sex: Female, Male Female | 171 Participants |
| Sex: Female, Male Male | 186 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 85 / 341 | 104 / 340 | 161 / 356 |
| serious Total, serious adverse events | 13 / 341 | 21 / 340 | 33 / 356 |
Outcome results
Primary
Change From Baseline in Forced Expiratory Volume (FEV1) Area Under the Curve (AUC) 0-24h
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.
Time frame: baseline, 0 to 24 hours post-dose at week 12
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 point were included in the analysis.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| QVA149 | Change From Baseline in Forced Expiratory Volume (FEV1) Area Under the Curve (AUC) 0-24h | 0.2321 Liters | Standard Error 0.01133 |
| Umeclidinium/Vilanterol | Change From Baseline in Forced Expiratory Volume (FEV1) Area Under the Curve (AUC) 0-24h | 0.2436 Liters | Standard Error 0.0113 |
Comparison: Ho: QVA149 27.5/12.5 μg b.i.d. is inferior to umeclidinium/vilanterol 62.5/25 μg q.d; Ha: QVA149 27.5/12.5 μg b.i.d. is non-inferior to umeclidinium/vilanterol 62.5/25 μg q.d.p-value: 0.13995% CI: [-0.0269, 0.0038]Linear Mixed Model
Secondary
Change From Baseline in FEV1 AUC 0-12h
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).
Time frame: baseline, 0 to 12 hours post-dose at week 12
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 point were included in the analysis.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| QVA149 | Change From Baseline in FEV1 AUC 0-12h | 0.2543 Liter | Standard Error 0.01031 |
| Umeclidinium/Vilanterol | Change From Baseline in FEV1 AUC 0-12h | 0.2848 Liter | Standard Error 0.01026 |
Secondary
Change From Baseline in FEV1 AUC 0-4h, AUC 4-8h, AUC 8-12h, AUC 12-16h, AUC 16-20h and AUC 20-24h
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.
Time frame: baseline, 12 weeks
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.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| QVA149 | 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 |
| QVA149 | 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 |
| QVA149 | 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 |
| QVA149 | 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 |
| QVA149 | 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 |
| QVA149 | 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 |
| Umeclidinium/Vilanterol | 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) | 0.1821 Liter | Standard Error 0.01133 |
| Umeclidinium/Vilanterol | 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 | 0.3289 Liter | Standard Error 0.0108 |
| Umeclidinium/Vilanterol | 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 | 0.1875 Liter | Standard Error 0.01244 |
| Umeclidinium/Vilanterol | 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 | 0.2411 Liter | Standard Error 0.01062 |
| Umeclidinium/Vilanterol | 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 | 0.2831 Liter | Standard Error 0.01045 |
| Umeclidinium/Vilanterol | 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 | 0.2349 Liter | Standard Error 0.01236 |
Secondary
Change From Baseline in FEV1 AUC 12-24h
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).
Time frame: baseline, 12 hours to 24 hours post-dose at week 12
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 point were included in the analysis.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| QVA149 | Change From Baseline in FEV1 AUC 12-24h | 0.2076 Liters | Standard Error 0.01159 |
| Umeclidinium/Vilanterol | Change From Baseline in FEV1 AUC 12-24h | 0.2025 Liters | Standard Error 0.01156 |
95% CI: [-0.0108, 0.0209]
Secondary
Change From Baseline in Forced Expiratory Volume (FEV1) Area Under the Curve (AUC) 0-24h
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.
Time frame: baseline, 0 to 24 hours post-dose at week 12
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 post-baseline time point were included in the analysis.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| QVA149 | Change From Baseline in Forced Expiratory Volume (FEV1) Area Under the Curve (AUC) 0-24h | 0.2321 Liters | Standard Error 0.01133 |
| Umeclidinium/Vilanterol | Change From Baseline in Forced Expiratory Volume (FEV1) Area Under the Curve (AUC) 0-24h | 0.2436 Liters | Standard Error 0.0113 |
Comparison: Ho: QVA149 27.5/12.5 μg b.i.d. is inferior to umeclidinium/vilanterol 62.5/25 μg q.d; Ha: QVA149 27.5/12.5 μg b.i.d. is non-inferior to umeclidinium/vilanterol 62.5/25 μg q.d.95% CI: [-0.0269, 0.0038]
Secondary
Change From Baseline in Pre-dose Trough FEV1 (Mean of 15 Minutes and 45 Minutes Pre Morning Dose)
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.
Time frame: baseline, 15 minutes and 45 minutes pre morning dose at week 12
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 point were included in the analysis.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| QVA149 | 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 |
| Umeclidinium/Vilanterol | Change From Baseline in Pre-dose Trough FEV1 (Mean of 15 Minutes and 45 Minutes Pre Morning Dose) | 0.2450 Liter | Standard Error 0.01135 |
Secondary
Change From Baseline in Trough FEV1 (Mean of 23h 15 Minutes and 23 h 45 Minutes Post Previous Morning Dose)
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
Time frame: baseline, 23 hours 15 minutes and 23 hours 45 minutes post previous morning dose at week 12
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 point were included in the analysis.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| QVA149 | 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 0.0107 |
| Umeclidinium/Vilanterol | Change From Baseline in Trough FEV1 (Mean of 23h 15 Minutes and 23 h 45 Minutes Post Previous Morning Dose) | 0.2043 Liters | Standard Error 0.01069 |
95% CI: [-0.0361, 0.0056]
Secondary
QVA149 Compared to Umeclidinium/Vilanterol in Terms of Change From Baseline in FEV1 at Any Time Point
FEV1 was measured with spirometry conducted according to internationally accepted standards.
Time frame: 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.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| QVA149 | 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 |
| QVA149 | 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 |
| QVA149 | 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 |
| QVA149 | 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 |
| QVA149 | 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 |
| QVA149 | 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 |
| QVA149 | 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 |
| QVA149 | 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 |
| QVA149 | 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 |
| QVA149 | 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 |
| QVA149 | 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 |
| QVA149 | 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 |
| QVA149 | 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 |
| QVA149 | 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 |
| QVA149 | 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 |
| QVA149 | 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 |
| QVA149 | 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 |
| QVA149 | 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 |
| QVA149 | 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 |
| QVA149 | 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 |
| QVA149 | 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 |
| QVA149 | 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 |
| QVA149 | 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 |
| QVA149 | 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 |
| QVA149 | 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 |
| QVA149 | 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 |
| QVA149 | 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 |
| QVA149 | 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 |
| QVA149 | 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 |
| QVA149 | 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 |
| QVA149 | 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 |
| Umeclidinium/Vilanterol | QVA149 Compared to Umeclidinium/Vilanterol in Terms of Change From Baseline in FEV1 at Any Time Point | Week 12, 12 hours 30 minutes | 0.2350 Liter | Standard Error 0.01302 |
| Umeclidinium/Vilanterol | QVA149 Compared to Umeclidinium/Vilanterol in Terms of Change From Baseline in FEV1 at Any Time Point | Day 1, 5 minutes | 0.1201 Liter | Standard Error 0.01007 |
| Umeclidinium/Vilanterol | QVA149 Compared to Umeclidinium/Vilanterol in Terms of Change From Baseline in FEV1 at Any Time Point | Week 12, 1 hour | 0.3334 Liter | Standard Error 0.01119 |
| Umeclidinium/Vilanterol | QVA149 Compared to Umeclidinium/Vilanterol in Terms of Change From Baseline in FEV1 at Any Time Point | Day 1, 15 minutes | 0.1682 Liter | Standard Error 0.01048 |
| Umeclidinium/Vilanterol | QVA149 Compared to Umeclidinium/Vilanterol in Terms of Change From Baseline in FEV1 at Any Time Point | Week 12, 20 hours | 0.1629 Liter | Standard Error 0.01273 |
| Umeclidinium/Vilanterol | QVA149 Compared to Umeclidinium/Vilanterol in Terms of Change From Baseline in FEV1 at Any Time Point | Day 1, 30 minutes | 0.1945 Liter | Standard Error 0.01073 |
| Umeclidinium/Vilanterol | QVA149 Compared to Umeclidinium/Vilanterol in Terms of Change From Baseline in FEV1 at Any Time Point | Week 12, 2 hours | 0.3445 Liter | Standard Error 0.01175 |
| Umeclidinium/Vilanterol | QVA149 Compared to Umeclidinium/Vilanterol in Terms of Change From Baseline in FEV1 at Any Time Point | Day 1, 1 hour | 0.2230 Liter | Standard Error 0.011 |
| Umeclidinium/Vilanterol | QVA149 Compared to Umeclidinium/Vilanterol in Terms of Change From Baseline in FEV1 at Any Time Point | Week 12, 13 hours | 0.2448 Liter | Standard Error 0.01294 |
| Umeclidinium/Vilanterol | QVA149 Compared to Umeclidinium/Vilanterol in Terms of Change From Baseline in FEV1 at Any Time Point | Day 1, 2 hours | 0.2329 Liter | Standard Error 0.01157 |
| Umeclidinium/Vilanterol | QVA149 Compared to Umeclidinium/Vilanterol in Terms of Change From Baseline in FEV1 at Any Time Point | Week 12, 4 hours | 0.3137 Liter | Standard Error 0.01126 |
| Umeclidinium/Vilanterol | QVA149 Compared to Umeclidinium/Vilanterol in Terms of Change From Baseline in FEV1 at Any Time Point | Day 1, 4 hours | 0.2270 Liter | Standard Error 0.01105 |
| Umeclidinium/Vilanterol | QVA149 Compared to Umeclidinium/Vilanterol in Terms of Change From Baseline in FEV1 at Any Time Point | Week 12, 23 hours 45 minutes | 0.2117 Liter | Standard Error 0.01118 |
| Umeclidinium/Vilanterol | QVA149 Compared to Umeclidinium/Vilanterol in Terms of Change From Baseline in FEV1 at Any Time Point | Day 1, 8 hours | 0.1861 Liter | Standard Error 0.01056 |
| Umeclidinium/Vilanterol | QVA149 Compared to Umeclidinium/Vilanterol in Terms of Change From Baseline in FEV1 at Any Time Point | Week 12, 8 hours | 0.2545 Liter | Standard Error 0.01071 |
| Umeclidinium/Vilanterol | QVA149 Compared to Umeclidinium/Vilanterol in Terms of Change From Baseline in FEV1 at Any Time Point | Day 1, 11 hours 55 minutes | 0.1674 Liter | Standard Error 0.01138 |
| Umeclidinium/Vilanterol | QVA149 Compared to Umeclidinium/Vilanterol in Terms of Change From Baseline in FEV1 at Any Time Point | Week 12, 14 hours | 0.2355 Liter | Standard Error 0.01314 |
| Umeclidinium/Vilanterol | QVA149 Compared to Umeclidinium/Vilanterol in Terms of Change From Baseline in FEV1 at Any Time Point | Day 1, 23 hours 15 minutes | 0.1764 Liter | Standard Error 0.01063 |
| Umeclidinium/Vilanterol | QVA149 Compared to Umeclidinium/Vilanterol in Terms of Change From Baseline in FEV1 at Any Time Point | Week 12, 11 hours 55 minutes | 0.2311 Liter | Standard Error 0.01151 |
| Umeclidinium/Vilanterol | QVA149 Compared to Umeclidinium/Vilanterol in Terms of Change From Baseline in FEV1 at Any Time Point | Day 1, 23 hours 45 minutes | 0.1932 Liter | Standard Error 0.0109 |
| Umeclidinium/Vilanterol | 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) | 0.1981 Liter | Standard Error 0.01088 |
| Umeclidinium/Vilanterol | QVA149 Compared to Umeclidinium/Vilanterol in Terms of Change From Baseline in FEV1 at Any Time Point | Week 6, -45 minutes | 0.2469 Liter | Standard Error 0.01141 |
| Umeclidinium/Vilanterol | QVA149 Compared to Umeclidinium/Vilanterol in Terms of Change From Baseline in FEV1 at Any Time Point | Week 12, 12 hours 5 minutes | 0.2218 Liter | Standard Error 0.01242 |
| Umeclidinium/Vilanterol | QVA149 Compared to Umeclidinium/Vilanterol in Terms of Change From Baseline in FEV1 at Any Time Point | Week 6, -15 minutes | 0.2668 Liter | Standard Error 0.01179 |
| Umeclidinium/Vilanterol | QVA149 Compared to Umeclidinium/Vilanterol in Terms of Change From Baseline in FEV1 at Any Time Point | Week 12, -15 minutes | 0.2538 Liter | Standard Error 0.01179 |
| Umeclidinium/Vilanterol | QVA149 Compared to Umeclidinium/Vilanterol in Terms of Change From Baseline in FEV1 at Any Time Point | Week 12, 16 hours | 0.2197 Liter | Standard Error 0.01296 |
| Umeclidinium/Vilanterol | QVA149 Compared to Umeclidinium/Vilanterol in Terms of Change From Baseline in FEV1 at Any Time Point | Week 12, 5 minutes | 0.2831 Liter | Standard Error 0.01027 |
| Umeclidinium/Vilanterol | QVA149 Compared to Umeclidinium/Vilanterol in Terms of Change From Baseline in FEV1 at Any Time Point | Week 12, 12 hours 15 minutes | 0.2324 Liter | Standard Error 0.01282 |
| Umeclidinium/Vilanterol | QVA149 Compared to Umeclidinium/Vilanterol in Terms of Change From Baseline in FEV1 at Any Time Point | Week 12, 15 minutes | 0.3074 Liter | Standard Error 0.01074 |
| Umeclidinium/Vilanterol | QVA149 Compared to Umeclidinium/Vilanterol in Terms of Change From Baseline in FEV1 at Any Time Point | Week 12, -45 minutes | 0.2378 Liter | Standard Error 0.01146 |
| Umeclidinium/Vilanterol | QVA149 Compared to Umeclidinium/Vilanterol in Terms of Change From Baseline in FEV1 at Any Time Point | Week 12, 30 minutes | 0.3258 Liter | Standard Error 0.01091 |
Secondary
QVA149 Compared to Umeclidinium/Vilanterol in Terms of Change From Baseline in Forced Vital Capacity (FVC) at Any Time Point
FEV1 was measured with spirometry conducted according to internationally accepted standards.
Time frame: 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.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| QVA149 | 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 |
| QVA149 | 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 |
| QVA149 | 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 |
| QVA149 | 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 |
| QVA149 | 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 |
| QVA149 | 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 |
| QVA149 | 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 |
| QVA149 | 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 |
| QVA149 | 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 |
| QVA149 | 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 |
| QVA149 | 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 |
| QVA149 | 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 |
| QVA149 | 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 |
| QVA149 | 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 |
| QVA149 | 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 0.0176 |
| QVA149 | 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 |
| QVA149 | 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 |
| QVA149 | 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 |
| QVA149 | 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 |
| QVA149 | 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 0.0449 |
| QVA149 | 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 |
| QVA149 | 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 |
| QVA149 | 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 |
| QVA149 | 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 |
| QVA149 | 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 |
| QVA149 | 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 |
| QVA149 | 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 |
| QVA149 | 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 |
| QVA149 | 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 0.0218 |
| QVA149 | 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 |
| QVA149 | 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 |
| Umeclidinium/Vilanterol | QVA149 Compared to Umeclidinium/Vilanterol in Terms of Change From Baseline in Forced Vital Capacity (FVC) at Any Time Point | Week 12, 15 minutes | 0.4169 Liter | Standard Error 0.01857 |
| Umeclidinium/Vilanterol | QVA149 Compared to Umeclidinium/Vilanterol in Terms of Change From Baseline in Forced Vital Capacity (FVC) at Any Time Point | Day 1, 5 minutes | 0.2218 Liter | Standard Error 0.01726 |
| Umeclidinium/Vilanterol | 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 | 0.3235 Liter | Standard Error 0.0207 |
| Umeclidinium/Vilanterol | QVA149 Compared to Umeclidinium/Vilanterol in Terms of Change From Baseline in Forced Vital Capacity (FVC) at Any Time Point | Day 1, 15 minutes | 0.2927 Liter | Standard Error 0.01821 |
| Umeclidinium/Vilanterol | QVA149 Compared to Umeclidinium/Vilanterol in Terms of Change From Baseline in Forced Vital Capacity (FVC) at Any Time Point | Week 12, 30 minutes | 0.4480 Liter | Standard Error 0.01875 |
| Umeclidinium/Vilanterol | QVA149 Compared to Umeclidinium/Vilanterol in Terms of Change From Baseline in Forced Vital Capacity (FVC) at Any Time Point | Day 1, 30 minutes | 0.3325 Liter | Standard Error 0.01849 |
| Umeclidinium/Vilanterol | QVA149 Compared to Umeclidinium/Vilanterol in Terms of Change From Baseline in Forced Vital Capacity (FVC) at Any Time Point | Week 12, 16 hours | 0.3279 Liter | Standard Error 0.02189 |
| Umeclidinium/Vilanterol | QVA149 Compared to Umeclidinium/Vilanterol in Terms of Change From Baseline in Forced Vital Capacity (FVC) at Any Time Point | Day 1, 1 hour | 0.3534 Liter | Standard Error 0.01904 |
| Umeclidinium/Vilanterol | QVA149 Compared to Umeclidinium/Vilanterol in Terms of Change From Baseline in Forced Vital Capacity (FVC) at Any Time Point | Week 12, 1 hour | 0.4647 Liter | Standard Error 0.01934 |
| Umeclidinium/Vilanterol | QVA149 Compared to Umeclidinium/Vilanterol in Terms of Change From Baseline in Forced Vital Capacity (FVC) at Any Time Point | Day 1, 2 hours | 0.3687 Liter | Standard Error 0.0196 |
| Umeclidinium/Vilanterol | 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 | 0.3326 Liter | Standard Error 0.02187 |
| Umeclidinium/Vilanterol | QVA149 Compared to Umeclidinium/Vilanterol in Terms of Change From Baseline in Forced Vital Capacity (FVC) at Any Time Point | Day 1, 4 hours | 0.4237 Liter | Standard Error 0.04339 |
| Umeclidinium/Vilanterol | QVA149 Compared to Umeclidinium/Vilanterol in Terms of Change From Baseline in Forced Vital Capacity (FVC) at Any Time Point | Week 12, 2 hours | 0.4853 Liter | Standard Error 0.01987 |
| Umeclidinium/Vilanterol | QVA149 Compared to Umeclidinium/Vilanterol in Terms of Change From Baseline in Forced Vital Capacity (FVC) at Any Time Point | Day 1, 8 hours | 0.3237 Liter | Standard Error 0.01818 |
| Umeclidinium/Vilanterol | 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 | 0.2750 Liter | Standard Error 0.01792 |
| Umeclidinium/Vilanterol | 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 | 0.2910 Liter | Standard Error 0.01889 |
| Umeclidinium/Vilanterol | QVA149 Compared to Umeclidinium/Vilanterol in Terms of Change From Baseline in Forced Vital Capacity (FVC) at Any Time Point | Week 12, 4 hours | 0.4343 Liter | Standard Error 0.04435 |
| Umeclidinium/Vilanterol | 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 | 0.2747 Liter | Standard Error 0.01753 |
| Umeclidinium/Vilanterol | QVA149 Compared to Umeclidinium/Vilanterol in Terms of Change From Baseline in Forced Vital Capacity (FVC) at Any Time Point | Week 12, 13 hours | 0.3361 Liter | Standard Error 0.02104 |
| Umeclidinium/Vilanterol | 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 | 0.3001 Liter | Standard Error 0.01883 |
| Umeclidinium/Vilanterol | QVA149 Compared to Umeclidinium/Vilanterol in Terms of Change From Baseline in Forced Vital Capacity (FVC) at Any Time Point | Week 12, 8 hours | 0.3555 Liter | Standard Error 0.01844 |
| Umeclidinium/Vilanterol | QVA149 Compared to Umeclidinium/Vilanterol in Terms of Change From Baseline in Forced Vital Capacity (FVC) at Any Time Point | Week 6, -45 minutes | 0.3513 Liter | Standard Error 0.01851 |
| Umeclidinium/Vilanterol | QVA149 Compared to Umeclidinium/Vilanterol in Terms of Change From Baseline in Forced Vital Capacity (FVC) at Any Time Point | Week 12, 20 hours | 0.2353 Liter | Standard Error 0.02167 |
| Umeclidinium/Vilanterol | QVA149 Compared to Umeclidinium/Vilanterol in Terms of Change From Baseline in Forced Vital Capacity (FVC) at Any Time Point | Week 6, -15 minutes | 0.3732 Liter | Standard Error 0.01919 |
| Umeclidinium/Vilanterol | 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 | 0.3231 Liter | Standard Error 0.01911 |
| Umeclidinium/Vilanterol | QVA149 Compared to Umeclidinium/Vilanterol in Terms of Change From Baseline in Forced Vital Capacity (FVC) at Any Time Point | Week 12, -45 minutes | 0.3442 Liter | Standard Error 0.01859 |
| Umeclidinium/Vilanterol | QVA149 Compared to Umeclidinium/Vilanterol in Terms of Change From Baseline in Forced Vital Capacity (FVC) at Any Time Point | Week 12, 14 hours | 0.3371 Liter | Standard Error 0.02162 |
| Umeclidinium/Vilanterol | QVA149 Compared to Umeclidinium/Vilanterol in Terms of Change From Baseline in Forced Vital Capacity (FVC) at Any Time Point | Week 12, -15 minutes | 0.3566 Liter | Standard Error 0.01919 |
| Umeclidinium/Vilanterol | 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) | 0.3112 Liter | Standard Error 0.02038 |
| Umeclidinium/Vilanterol | QVA149 Compared to Umeclidinium/Vilanterol in Terms of Change From Baseline in Forced Vital Capacity (FVC) at Any Time Point | Week 12, 5 minutes | 0.3861 Liter | Standard Error 0.01756 |
| Umeclidinium/Vilanterol | 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) | 0.2728 Liter | Standard Error 0.01928 |