This study will assess the efficacy and safety of glycopyrronium bromide (NVA237) in patients with stable COPD, in comparison to an active comparator.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
83
single-dose dry-powder inhaler (SDDPI)
single-dose dry-powder inhaler (SDDPI)
Handihaler inhaler
Novartis Investigator Site
Vilvoorde, Belgium
Novartis Investigator Site
Rueil-Malmaison, France
Novartis Investigator site
Tokyo, Japan
Trough Forced Expiratory Volume in 1 Second (FEV1) Following 7 Days of Treatment
FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation, measured through spirometry testing. The trough in FEV1 was defined as the mean of two measurements at 23h 15min and 23h 45min post dosing.
Time frame: Day 7
Least Squares Means of FEV1 (L) at Day 1, by Timepoint
FEV1 was measured at 5, 15, 30 minutes, 1, 2, 3, 4, 5, 23 hours and 15 minutes, and 23 hours and 45 minutes post dose.
Time frame: Day 1
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