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
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What molecular mechanisms of Glycopyrrolate's anticholinergic action improve COPD subtypes like emphysema and chronic bronchitis?
How does Glycopyrrolate compare to tiotropium in reducing COPD exacerbations in Indian outpatient settings?
Which biomarkers (e.g., FEV1, sputum eosinophils) predict Glycopyrrolate response in post-marketing COPD trials?
What long-term adverse events were reported in the GOAAL study for Glycopyrrolate-treated COPD patients in India?
Are there combination therapies with Glycopyrrolate and beta-agonists for COPD, and how do they compare to monotherapies by Glenmark and competitors?