This study will assess the Efficacy of NVA237 (50 μg o.d) using tiotropium (5μg μg o.d) as active control in COPD patients.
A 52-week treatment, multicenter, randomized, open-label, parallel-group study to assess the efficacy of NVA237 (50μg once daily) using Tiotropium (5μg once daily) as an active control in Brazilian patients with moderate to severe Chronic Obstructive Pulmonary Disease.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Once daily for 52 weeks
Once daily for 52 weeks
Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1)
Forced expiratory volume in 1 second (FEV1) is the amount of air that can be exhaled in one second. FEV1 will be measured by spirometry. A positive change from baseline in FEV1 indicates improvement in lung function.
Time frame: Baseline and 12 weeks after treatment.
Forced Expiratory Volume in 1 Second (FEV1) at day 1
Forced expiratory volume in 1 second (FEV1) is the amount of air that can be exhaled in one second. FEV1 will be measured by spirometry. A positive change from baseline in FEV1 indicates improvement in lung function.
Time frame: 30 and 60 minutes post-dose on the first day of study treatment.
Forced Expiratory Volume in 1 Second (FEV1) at day 7 and weeks 12, 24 and 52
Forced expiratory volume in 1 second (FEV1) is the amount of air that can be exhaled in one second. FEV1 will be measured by spirometry. A positive change from baseline in FEV1 indicates improvement in lung function.
Time frame: 30 and 60 minutes post-dose on the 7th day of study treatment and at weeks 12, 24 and 52
Forced Expiratory Volume in 1 Second (FEV1) at weeks 24 and 52
Forced expiratory volume in 1 second (FEV1) is the amount of air that can be exhaled in one second. FEV1 will be measured by spirometry. A positive change from baseline in FEV1 indicates improvement in lung function.
Time frame: pre-dose at weeks 24 and 52 of study treatment
Change From Baseline in Forced Vital Capacity (FVC)
Forced Vital Capacity (FVC) is the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. FVC was assessed via spirometry. A positive change from baseline in FVC indicates improvement in lung function.
Time frame: Days 1 and 7, weeks 12, 24 and 52 of study treatment
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FEV1 AUC 0-4h
Forced Vital Capacity (FVC) is the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. FVC was assessed via spirometry. A positive change from baseline in FVC indicates improvement in lung function.
Time frame: 05, 30, 60 minutes and 4 hours post-dose at days 1, 7 and week 12
Safety and tolerance of NVA237
All AEs and SAEs will be reported
Time frame: 52 weeks