This study was conducted to provide detailed information on the efficacy of indacaterol (in terms of the spirometry assessment forced expiratory volume in 1 second \[FEV1\]) over the full 24-h time period
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
96
300 µg dosed in the morning/evening via single dose dry powder inhaler (SDDPI)
50 µg twice daily delivered via dry powder inhaler (DPI)
Placebo matching indacaterol was delivered via SDDPI.
Novartis Investigative Site
Beuvry, France
Novartis Investigative Site
Nantes, France
Novartis Investigative Site
Berlin, Germany
Novartis Investigative Site
Hamburg, Germany
Trough Forced Expiratory Volume in 1 Second (FEV1) Following 14 Days of Evening Dosing of Indacaterol Versus Placebo
Trough FEV1 was assessed by performing spirometry measurements in the clinic for each treatment period. For the primary efficacy variable, trough FEV1 is the mean of two measurements taken at 23h 10 min and 23h 45 min post dose. The primary variable was analyzed using an analysis of covariance (ANCOVA) model with the (period) baseline FEV1 as covariate. The (period) baseline FEV1 was defined as the value measured before the study drug administration in that treatment period.
Time frame: After 14 days of treatment
Trough FEV1 Assessed After 14 Days of Dosing for All Other Treatment Comparisons
Trough FEV1 was assessed by performing spirometry measurements in the clinic for each treatment period. On the morning and evening of Day 15 trough FEV1 (i.e. mean of measurements performed 23 h 10 min and 23 h 45 min post-dose) were assessed. An analysis of covariance (ANCOVA) model was used with the (period) baseline FEV1 as covariate. The (period) baseline FEV1 was defined as the value measured before the study drug administration in that treatment period.
Time frame: After 14 days of dosing
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Placebo matching salmeterol was delivered via DPI
Novartis Investigative Site
Leipzig, Germany
Novartis Investigative Site
Mainz, Germany
Novartis Investigative Site
Barcelona, Spain