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 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 |
|---|---|---|
| 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) | 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. |
| 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) | baseline, 12 weeks | 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, 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) | 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. | 355 |
| Total | 355 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Period: Period 1 | Adverse Event | 2 | 4 |
| Period: Period 1 | Lack of Efficacy | 1 | 0 |
| Period: Period 1 | Lost to Follow-up | 0 | 2 |
| Period: Period 1 | Physician Decision | 0 | 1 |
| Period: Period 1 | Protocol deviation | 1 | 0 |
| Period: Period 1 | Subject/guardian decision | 2 | 4 |
| Period: Period 2 | Adverse Event | 2 | 2 |
| Period: Period 2 | Death | 0 | 1 |
| Period: Period 2 | Lost to Follow-up | 1 | 1 |
| Period: Period 2 | Physician Decision | 1 | 0 |
| Period: Period 2 | Subject/guardian decision | 2 | 1 |
| Period: Washout | Lack of Efficacy | 1 | 1 |
| Period: Washout | Non-compliance with study treatment | 0 | 1 |
| Period: Washout | Physician Decision | 1 | 0 |
| Period: Washout | Subject/guardian decision | 0 | 5 |
Baseline characteristics
| Characteristic | Overall Participants |
|---|---|
| Age, Continuous | 63.9 Years STANDARD_DEVIATION 8.3 |
| Sex: Female, Male Female | 163 Participants |
| Sex: Female, Male Male | 192 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 | 78 / 337 | 89 / 347 | 140 / 355 |
| serious Total, serious adverse events | 17 / 337 | 10 / 347 | 26 / 355 |
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 |
|---|---|---|---|
| First QVA149, Then Umeclidinium/Vilanterol | Change From Baseline in Forced Expiratory Volume (FEV1) Area Under the Curve (AUC) 0-24h | 0.1846 Liters | Standard Error 0.01193 |
| First Umeclidinium/Vilanterol, Then QVA149 | Change From Baseline in Forced Expiratory Volume (FEV1) Area Under the Curve (AUC) 0-24h | 0.2028 Liters | Standard Error 0.01188 |
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: 0.41595% CI: [-0.0342, -0.0023]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 |
|---|---|---|---|
| First QVA149, Then Umeclidinium/Vilanterol | Change From Baseline in FEV1 AUC 0-12h | 0.2077 Liters | Standard Error 0.01082 |
| First Umeclidinium/Vilanterol, Then QVA149 | Change From Baseline in FEV1 AUC 0-12h | 0.2496 Liters | Standard Error 0.01075 |
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 |
|---|---|---|---|---|
| First QVA149, Then 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 | 0.1383 Liter | Standard Error 0.01292 |
| First QVA149, Then 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 | 0.1374 Liter | Standard Error 0.01197 |
| First QVA149, Then 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 | 0.2663 Liter | Standard Error 0.01082 |
| First QVA149, Then 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 | 0.1970 Liter | Standard Error 0.01132 |
| First QVA149, Then 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 | 0.1513 Liter | Standard Error 0.01143 |
| First QVA149, Then 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 | 0.2120 Liter | Standard Error 0.01292 |
| First Umeclidinium/Vilanterol, Then 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 | 0.2015 Liter | Standard Error 0.01132 |
| First Umeclidinium/Vilanterol, Then 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 | 0.1340 Liter | Standard Error 0.01287 |
| First Umeclidinium/Vilanterol, Then 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 | 0.2519 Liter | Standard Error 0.01123 |
| First Umeclidinium/Vilanterol, Then 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 | 0.1445 Liter | Standard Error 0.0119 |
| First Umeclidinium/Vilanterol, Then 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 | 0.1842 Liter | Standard Error 0.01285 |
| First Umeclidinium/Vilanterol, Then 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 | 0.2938 Liter | Standard Error 0.01077 |
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 |
|---|---|---|---|
| First QVA149, Then Umeclidinium/Vilanterol | Change From Baseline in FEV1 AUC 12-24h | 0.1625 Liters | Standard Error 0.01216 |
| First Umeclidinium/Vilanterol, Then QVA149 | Change From Baseline in FEV1 AUC 12-24h | 0.1539 Liters | Standard Error 0.0121 |
95% CI: [-0.0086, 0.0258]
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 |
|---|---|---|---|
| First QVA149, Then Umeclidinium/Vilanterol | Change From Baseline in Forced Expiratory Volume (FEV1) Area Under the Curve (AUC) 0-24h | 0.1846 Liters | Standard Error 0.01193 |
| First Umeclidinium/Vilanterol, Then QVA149 | Change From Baseline in Forced Expiratory Volume (FEV1) Area Under the Curve (AUC) 0-24h | 0.2028 Liters | Standard Error 0.01188 |
95% CI: [-0.0342, -0.0023]
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 |
|---|---|---|---|---|
| First QVA149, Then Umeclidinium/Vilanterol | 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 0.0116 |
| First QVA149, Then Umeclidinium/Vilanterol | 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 |
| First QVA149, Then Umeclidinium/Vilanterol | 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 0.0108 |
| First QVA149, Then Umeclidinium/Vilanterol | 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 |
| First QVA149, Then 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 | 0.1702 Liters | Standard Error 0.01156 |
| First QVA149, Then Umeclidinium/Vilanterol | 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 |
| First QVA149, Then Umeclidinium/Vilanterol | 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 |
| First QVA149, Then Umeclidinium/Vilanterol | 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 |
| First QVA149, Then Umeclidinium/Vilanterol | 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 |
| First QVA149, Then Umeclidinium/Vilanterol | 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 0.0102 |
| First QVA149, Then Umeclidinium/Vilanterol | 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 |
| First QVA149, Then Umeclidinium/Vilanterol | 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 |
| First QVA149, Then Umeclidinium/Vilanterol | 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 |
| First QVA149, Then Umeclidinium/Vilanterol | 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 |
| First QVA149, Then 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 | 0.2296 Liters | Standard Error 0.01355 |
| First QVA149, Then Umeclidinium/Vilanterol | 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 |
| First QVA149, Then Umeclidinium/Vilanterol | 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 |
| First QVA149, Then Umeclidinium/Vilanterol | 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 |
| First QVA149, Then Umeclidinium/Vilanterol | 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 |
| First QVA149, Then 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 | 0.1573 Liters | Standard Error 0.01117 |
| First QVA149, Then 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 | 0.1798 Liters | Standard Error 0.01163 |
| First QVA149, Then Umeclidinium/Vilanterol | 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 |
| First QVA149, Then Umeclidinium/Vilanterol | 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 |
| First QVA149, Then Umeclidinium/Vilanterol | 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 |
| First QVA149, Then 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 | 0.0521 Liters | Standard Error 0.01203 |
| First QVA149, Then 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 | 0.1422 Liters | Standard Error 0.01109 |
| First QVA149, Then Umeclidinium/Vilanterol | 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 |
| First QVA149, Then Umeclidinium/Vilanterol | 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 |
| First QVA149, Then 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 | 0.1320 Liters | Standard Error 0.01236 |
| First QVA149, Then 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 | 0.1974 Liters | Standard Error 0.01375 |
| First QVA149, Then 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 | 0.2107 Liters | Standard Error 0.01375 |
| First Umeclidinium/Vilanterol, Then QVA149 | QVA149 Compared to Umeclidinium/Vilanterol in Terms of Change From Baseline in FEV1 at Any Time Point | Week 12, 13 hours | 0.1953 Liters | Standard Error 0.01364 |
| First Umeclidinium/Vilanterol, Then QVA149 | QVA149 Compared to Umeclidinium/Vilanterol in Terms of Change From Baseline in FEV1 at Any Time Point | Day 1, 5 minutes | 0.1117 Liters | Standard Error 0.00984 |
| First Umeclidinium/Vilanterol, Then QVA149 | QVA149 Compared to Umeclidinium/Vilanterol in Terms of Change From Baseline in FEV1 at Any Time Point | Week 12, 12 hours 15 minutes | 0.1959 Liters | Standard Error 0.01368 |
| First Umeclidinium/Vilanterol, Then QVA149 | QVA149 Compared to Umeclidinium/Vilanterol in Terms of Change From Baseline in FEV1 at Any Time Point | Day 1, 15 minutes | 0.1591 Liters | Standard Error 0.01053 |
| First Umeclidinium/Vilanterol, Then QVA149 | QVA149 Compared to Umeclidinium/Vilanterol in Terms of Change From Baseline in FEV1 at Any Time Point | Week 12, 14 hours | 0.1966 Liters | Standard Error 0.01357 |
| First Umeclidinium/Vilanterol, Then QVA149 | QVA149 Compared to Umeclidinium/Vilanterol in Terms of Change From Baseline in FEV1 at Any Time Point | Day 1, 30 minutes | 0.1836 Liters | Standard Error 0.01071 |
| First Umeclidinium/Vilanterol, Then QVA149 | QVA149 Compared to Umeclidinium/Vilanterol in Terms of Change From Baseline in FEV1 at Any Time Point | Day 1, 8 hours | 0.1781 Liters | Standard Error 0.01145 |
| First Umeclidinium/Vilanterol, Then QVA149 | QVA149 Compared to Umeclidinium/Vilanterol in Terms of Change From Baseline in FEV1 at Any Time Point | Day 1, 23 hours 15 minutes | 0.1573 Liters | Standard Error 0.01099 |
| First Umeclidinium/Vilanterol, Then QVA149 | QVA149 Compared to Umeclidinium/Vilanterol in Terms of Change From Baseline in FEV1 at Any Time Point | Week 12, 16 hours | 0.1582 Liters | Standard Error 0.01381 |
| First Umeclidinium/Vilanterol, Then QVA149 | QVA149 Compared to Umeclidinium/Vilanterol in Terms of Change From Baseline in FEV1 at Any Time Point | Day 1, 23 hours 45 minutes | 0.1821 Liters | Standard Error 0.01145 |
| First Umeclidinium/Vilanterol, Then QVA149 | QVA149 Compared to Umeclidinium/Vilanterol in Terms of Change From Baseline in FEV1 at Any Time Point | Week 12, 8 hours | 0.2201 Liters | Standard Error 0.01167 |
| First Umeclidinium/Vilanterol, Then QVA149 | QVA149 Compared to Umeclidinium/Vilanterol in Terms of Change From Baseline in FEV1 at Any Time Point | Week 6, -45 minutes | 0.2071 Liters | Standard Error 0.01188 |
| First Umeclidinium/Vilanterol, Then QVA149 | QVA149 Compared to Umeclidinium/Vilanterol in Terms of Change From Baseline in FEV1 at Any Time Point | Week 12, 20 hours | 0.1158 Liters | Standard Error 0.01338 |
| First Umeclidinium/Vilanterol, Then QVA149 | QVA149 Compared to Umeclidinium/Vilanterol in Terms of Change From Baseline in FEV1 at Any Time Point | Week 6, -15 minutes | 0.2343 Liters | Standard Error 0.01214 |
| First Umeclidinium/Vilanterol, Then QVA149 | QVA149 Compared to Umeclidinium/Vilanterol in Terms of Change From Baseline in FEV1 at Any Time Point | Day 1, 11 hours 55 minutes | 0.1537 Liters | Standard Error 0.01185 |
| First Umeclidinium/Vilanterol, Then QVA149 | QVA149 Compared to Umeclidinium/Vilanterol in Terms of Change From Baseline in FEV1 at Any Time Point | Week 12, -45 minutes | 0.1957 Liters | Standard Error 0.01191 |
| First Umeclidinium/Vilanterol, Then QVA149 | QVA149 Compared to Umeclidinium/Vilanterol in Terms of Change From Baseline in FEV1 at Any Time Point | Week 12, 23 hours 15 minutes | 0.1648 Liters | Standard Error 0.01115 |
| First Umeclidinium/Vilanterol, Then QVA149 | QVA149 Compared to Umeclidinium/Vilanterol in Terms of Change From Baseline in FEV1 at Any Time Point | Week 12, -15 minutes | 0.2112 Liters | Standard Error 0.01214 |
| First Umeclidinium/Vilanterol, Then QVA149 | QVA149 Compared to Umeclidinium/Vilanterol in Terms of Change From Baseline in FEV1 at Any Time Point | Week 12, 12 hours 5 minutes | 0.1893 Liters | Standard Error 0.01364 |
| First Umeclidinium/Vilanterol, Then QVA149 | QVA149 Compared to Umeclidinium/Vilanterol in Terms of Change From Baseline in FEV1 at Any Time Point | Week 12, 5 minutes | 0.2563 Liters | Standard Error 0.01015 |
| First Umeclidinium/Vilanterol, Then QVA149 | QVA149 Compared to Umeclidinium/Vilanterol in Terms of Change From Baseline in FEV1 at Any Time Point | Week 12, 23 hours 45 minutes | 0.1892 Liters | Standard Error 0.01167 |
| First Umeclidinium/Vilanterol, Then QVA149 | QVA149 Compared to Umeclidinium/Vilanterol in Terms of Change From Baseline in FEV1 at Any Time Point | Week 12, 15 minutes | 0.2865 Liters | Standard Error 0.01084 |
| First Umeclidinium/Vilanterol, Then QVA149 | QVA149 Compared to Umeclidinium/Vilanterol in Terms of Change From Baseline in FEV1 at Any Time Point | Day 1, 1 hour | 0.2000 Liters | Standard Error 0.01121 |
| First Umeclidinium/Vilanterol, Then QVA149 | QVA149 Compared to Umeclidinium/Vilanterol in Terms of Change From Baseline in FEV1 at Any Time Point | Week 12, 30 minutes | 0.2940 Liters | Standard Error 0.0109 |
| First Umeclidinium/Vilanterol, Then QVA149 | QVA149 Compared to Umeclidinium/Vilanterol in Terms of Change From Baseline in FEV1 at Any Time Point | Week 12, 11 hours 55 minutes | 0.1812 Liters | Standard Error 0.01193 |
| First Umeclidinium/Vilanterol, Then QVA149 | QVA149 Compared to Umeclidinium/Vilanterol in Terms of Change From Baseline in FEV1 at Any Time Point | Week 12, 1 hour | 0.3053 Liters | Standard Error 0.01141 |
| First Umeclidinium/Vilanterol, Then QVA149 | QVA149 Compared to Umeclidinium/Vilanterol in Terms of Change From Baseline in FEV1 at Any Time Point | Day 1, 2 hours | 0.2138 Liters | Standard Error 0.01136 |
| First Umeclidinium/Vilanterol, Then QVA149 | QVA149 Compared to Umeclidinium/Vilanterol in Terms of Change From Baseline in FEV1 at Any Time Point | Week 12, 2 hours | 0.2994 Liters | Standard Error 0.01158 |
| First Umeclidinium/Vilanterol, Then QVA149 | QVA149 Compared to Umeclidinium/Vilanterol in Terms of Change From Baseline in FEV1 at Any Time Point | Week 12, 4 hours | 0.2823 Liters | Standard Error 0.01185 |
| First Umeclidinium/Vilanterol, Then QVA149 | QVA149 Compared to Umeclidinium/Vilanterol in Terms of Change From Baseline in FEV1 at Any Time Point | Week 12, 12 hours 30 minutes | 0.1934 Liters | Standard Error 0.0135 |
| First Umeclidinium/Vilanterol, Then QVA149 | QVA149 Compared to Umeclidinium/Vilanterol in Terms of Change From Baseline in FEV1 at Any Time Point | Day 1, 4 hours | 0.2168 Liters | Standard Error 0.01165 |
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, 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.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| First QVA149, Then 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 | 0.1994 Liters | Standard Error 0.01672 |
| First QVA149, Then 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 | 0.2454 Liters | Standard Error 0.01764 |
| First QVA149, Then 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 | 0.2734 Liters | Standard Error 0.01806 |
| First QVA149, Then 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 | 0.2841 Liters | Standard Error 0.01937 |
| First QVA149, Then 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 | 0.2708 Liters | Standard Error 0.01928 |
| First QVA149, Then 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 | 0.2821 Liters | Standard Error 0.01886 |
| First QVA149, Then 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 | 0.2666 Liters | Standard Error 0.01958 |
| First QVA149, Then 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 | 0.2860 Liters | Standard Error 0.01963 |
| First QVA149, Then 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 | 0.2264 Liters | Standard Error 0.01956 |
| First QVA149, Then 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 | 0.2468 Liters | Standard Error 0.01949 |
| First QVA149, Then 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 | 0.3386 Liters | Standard Error 0.01711 |
| First QVA149, Then 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 | 0.3616 Liters | Standard Error 0.01771 |
| First QVA149, Then 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 | 0.3796 Liters | Standard Error 0.0183 |
| First QVA149, Then 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 | 0.3935 Liters | Standard Error 0.01962 |
| First QVA149, Then 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 | 0.3708 Liters | Standard Error 0.01953 |
| First QVA149, Then 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 | 0.3261 Liters | Standard Error 0.01933 |
| First QVA149, Then 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 | 0.2259 Liters | Standard Error 0.0195 |
| First QVA149, Then 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 | 0.1900 Liters | Standard Error 0.02023 |
| First QVA149, Then 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 | 0.2817 Liters | Standard Error 0.02157 |
| First QVA149, Then 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 | 0.3010 Liters | Standard Error 0.02177 |
| First QVA149, Then 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 | 0.3279 Liters | Standard Error 0.02155 |
| First QVA149, Then 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 | 0.3381 Liters | Standard Error 0.0221 |
| First QVA149, Then 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 | 0.3445 Liters | Standard Error 0.02233 |
| First QVA149, Then 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 | 0.2496 Liters | Standard Error 0.02191 |
| First QVA149, Then 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 | 0.1600 Liters | Standard Error 0.02168 |
| First QVA149, Then 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 | 0.2026 Liters | Standard Error 0.01802 |
| First QVA149, Then 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 | 0.2333 Liters | Standard Error 0.01914 |
| First QVA149, Then 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 | 0.1728 Liters | Standard Error 0.01923 |
| First QVA149, Then 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 | 0.1291 Liters | Standard Error 0.01971 |
| First QVA149, Then 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 | 0.2387 Liters | Standard Error 0.01789 |
| First QVA149, Then 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 | 0.2415 Liters | Standard Error 0.01897 |
| First Umeclidinium/Vilanterol, Then 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 | 0.3845 Liters | Standard Error 0.01924 |
| First Umeclidinium/Vilanterol, Then 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 | 0.2054 Liters | Standard Error 0.01655 |
| First Umeclidinium/Vilanterol, Then 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 | 0.2514 Liters | Standard Error 0.02188 |
| First Umeclidinium/Vilanterol, Then 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 | 0.2589 Liters | Standard Error 0.01724 |
| First Umeclidinium/Vilanterol, Then 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 | 0.3152 Liters | Standard Error 0.01936 |
| First Umeclidinium/Vilanterol, Then 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 | 0.3028 Liters | Standard Error 0.01792 |
| First Umeclidinium/Vilanterol, Then 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 | 0.2251 Liters | Standard Error 0.018 |
| First Umeclidinium/Vilanterol, Then 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 | 0.3136 Liters | Standard Error 0.01917 |
| First Umeclidinium/Vilanterol, Then 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 | 0.2749 Liters | Standard Error 0.01956 |
| First Umeclidinium/Vilanterol, Then 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 | 0.3334 Liters | Standard Error 0.01904 |
| First Umeclidinium/Vilanterol, Then 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 | 0.1845 Liters | Standard Error 0.02169 |
| First Umeclidinium/Vilanterol, Then 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 | 0.2940 Liters | Standard Error 0.01868 |
| First Umeclidinium/Vilanterol, Then 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 | 0.2711 Liters | Standard Error 0.02141 |
| First Umeclidinium/Vilanterol, Then 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 | 0.3045 Liters | Standard Error 0.01942 |
| First Umeclidinium/Vilanterol, Then 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 | 0.2654 Liters | Standard Error 0.01944 |
| First Umeclidinium/Vilanterol, Then 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 | 0.3372 Liters | Standard Error 0.01943 |
| First Umeclidinium/Vilanterol, Then 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 | 0.2762 Liters | Standard Error 0.02165 |
| First Umeclidinium/Vilanterol, Then 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 | 0.2737 Liters | Standard Error 0.01947 |
| First Umeclidinium/Vilanterol, Then 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 | 0.2662 Liters | Standard Error 0.01903 |
| First Umeclidinium/Vilanterol, Then 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 | 0.2844 Liters | Standard Error 0.01943 |
| First Umeclidinium/Vilanterol, Then 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 | 0.2786 Liters | Standard Error 0.02146 |
| First Umeclidinium/Vilanterol, Then 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 | 0.3489 Liters | Standard Error 0.01701 |
| First Umeclidinium/Vilanterol, Then 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 | 0.3405 Liters | Standard Error 0.01892 |
| First Umeclidinium/Vilanterol, Then 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 | 0.3811 Liters | Standard Error 0.01768 |
| First Umeclidinium/Vilanterol, Then 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 | 0.2909 Liters | Standard Error 0.02189 |
| First Umeclidinium/Vilanterol, Then 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 | 0.4019 Liters | Standard Error 0.01821 |
| First Umeclidinium/Vilanterol, Then 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 | 0.2363 Liters | Standard Error 0.01775 |
| First Umeclidinium/Vilanterol, Then 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 | 0.4085 Liters | Standard Error 0.01949 |
| First Umeclidinium/Vilanterol, Then 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 | 0.2984 Liters | Standard Error 0.02208 |
| First Umeclidinium/Vilanterol, Then 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 | 0.4050 Liters | Standard Error 0.01937 |
| First Umeclidinium/Vilanterol, Then 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 | 0.3067 Liters | Standard Error 0.019 |
Secondary
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)
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, 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 point were included in the analysis
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| First QVA149, Then Umeclidinium/Vilanterol | 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 |
| First Umeclidinium/Vilanterol, Then QVA149 | 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) | 0.2043 Liters | Standard Error 0.01177 |
Secondary
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)
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 |
|---|---|---|---|
| First QVA149, Then Umeclidinium/Vilanterol | 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 |
| First Umeclidinium/Vilanterol, Then QVA149 | 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) | 0.1767 Liters | Standard Error 0.01111 |
95% CI: [-0.0313, 0.0131]