Assessment of Glycopyrrolate in patients with breathing problems.
Phase 4
Completed
- Conditions
- Health Condition 1: J449- Chronic obstructive pulmonary disease, unspecifiedHealth Condition 2: null- COPD
- Registration Number
- CTRI/2018/04/012944
- Lead Sponsor
- Glenmark Pharmaceuticals Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 1215
Inclusion Criteria
1. COPD patients with GOLD B/C status who were symptomatic with more than or equal to 1 moderate to severe exacerbation in
last six months that required antibiotics or short course oral corticosteroids
2. FEV1/FVC less than 0.7 with FVC less than 80%
Exclusion Criteria
Patients with less than 1 follow up visit to be excluded
Study & Design
- Study Type
- PMS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Trough FEV1 improvementTimepoint: 4 weeks and 12 weeks
- Secondary Outcome Measures
Name Time Method Change in CAT scoreTimepoint: 12 weeks;Treatment Emergent Adverse EventsTimepoint: 12 weeks