This study will evaluate the safety and efficacy of QVA149 in patients with moderate to severe COPD.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
154
Inhalation capsule indacaterol/glycopyrrolate 300/50 μg inhaled once daily via a single dose dry powder inhaler for 7 days.
Inhalation capsule indacaterol supplied as 300 μg capsules inhaled once daily via a single dose dry powder inhaler for 7 days.
Placebo inhalation capsules inhaled once daily via a single dose dry powder inhaler for 7 days.
Novartis Investigator Site
St Louis, Missouri, United States
Novartis Investigator Site
Charlotte, North Carolina, United States
Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at Day 7
Spirometry testing was performed in accordance with American Thoracic Society standards. Trough FEV1 was defined as the average of the 23 hour 15 minute and 23 hour 45 minute measurements post dosing. Baseline FEV1 is the mean of the 45 minute and 15 minute pre-dose FEV1 values at day 1 of each period. Least square means are based on the Analysis of Covariance Trough FEV1 at day 7 = sequence effect + patient(sequence) + period effect + treatment effect + (period) baseline FEV1 + error.
Time frame: Baseline, Day 7
Standardized Forced Expiratory Volume in 1 Second (FEV1) Area Under Curve (AUC) 5 Minutes-12 Hours at Day 7
Spirometry testing was performed in accordance with American Thoracic Society standards. FEV1 was assessed at 5, 15, 30 minutes, 1, 2, 3, 4, 5, 6, 8, 10 and 12 hours post dose on Day 7. Standardized (with respect to time) AUC (5 minutes-12 hours) for FEV1 on day 7 was calculated using the trapezoidal rule. Least square means are based on the Analysis of Covariance: FEV1 AUC = sequence effect + patient (sequence) + period + treatment + baseline FEV1 (period) + error.
Time frame: Day 7
Number of Participants With Adverse Events, Serious Adverse Events and Discontinuations Due to Adverse Events
Additional information about adverse events can be found in the Adverse Event Section.
Time frame: 47 days
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Novartis Investigator site
Raleigh, North Carolina, United States
Novartis Investigator Site
Antwerp, Belgium
Novartis Investigator Site
Ghent, Belgium
Novartis Investigator Site
Jambes, Belgium
Novartis Investigator Site
Sankt Vith, Belgium
Novartis Investigator Site
Moncton, Canada
Novartis Investigator Site
Montreal, Canada
Novartis Investigator site
Toronto, Canada
...and 12 more locations