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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
355
QVA149 capsules for inhalation, delivered via QVA149 SDDPI
Umeclidinium/vilanterol for inhalation, delivered via ELLIPTA® inhaler
Matching Placebo to umeclidinium/vilanterol for inhalation, delivered via ELLIPTA® inhaler
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
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
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
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
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).
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Matching Placebo to QVA149 capsules for inhalation, delivered via QVA149 SDDPI
Novartis Investigative Site
Anaheim, California, United States
Novartis Investigative Site
Escondido, California, United States
Novartis Investigative Site
Riverside, California, United States
Novartis Investigative Site
San Diego, California, United States
Novartis Investigative Site
San Diego, California, United States
Novartis Investigative Site
San Diego, California, United States
Novartis Investigative Site
Chiefland, Florida, United States
Novartis Investigative Site
Clearwater, Florida, United States
Novartis Investigative Site
Gainesville, Florida, United States
Novartis Investigative Site
Miami, Florida, United States
...and 43 more locations
Time frame: baseline, 0 to 12 hours post-dose at week 12
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
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
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)
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)