A 52-week Treatment, Multi-center, Randomized, Open Label, Parallel Group Study to Assess the Efficacy of NVA237 (50 μg o.d.) Using Tiotropium (5 μg o.d.) as an Active Control in Brazilian Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease.
Trial Snapshot
- Phase
- Phase 3
- Status
- Withdrawn
- Sponsor
- Novartis Pharmaceuticals
- Primary Endpoint
- Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1)
Study Overview
Brief Summary
This study will assess the Efficacy of NVA237 (50 μg o.d) using tiotropium (5μg μg o.d) as active control in COPD patients.
Detailed Description
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 40 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
NVA237
NVA237 inhaled via the Breezhaler® device once daily
Intervention: NVA237 (Drug)
Tiotropium
Tiotropium 5μg inhaled via the Respimat® device once daily
Intervention: Tiotropium Respimat® (Drug)
Outcomes
Primary Outcomes
Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1)
Time Frame: Baseline and 12 weeks after treatment.
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.
Secondary Outcomes
- Safety and tolerance of NVA237(52 weeks)
- Forced Expiratory Volume in 1 Second (FEV1) at weeks 24 and 52(pre-dose at weeks 24 and 52 of study treatment)
- Change From Baseline in Forced Vital Capacity (FVC)(Days 1 and 7, weeks 12, 24 and 52 of study treatment)
- Forced Expiratory Volume in 1 Second (FEV1) at day 7 and weeks 12, 24 and 52(30 and 60 minutes post-dose on the 7th day of study treatment and at weeks 12, 24 and 52)
- FEV1 AUC 0-4h(05, 30, 60 minutes and 4 hours post-dose at days 1, 7 and week 12)
- Forced Expiratory Volume in 1 Second (FEV1) at day 1(30 and 60 minutes post-dose on the first day of study treatment.)