Study on utilization of glycopyrronium and arformoterol inhalation as a treatment for COPD.
Phase 4
Completed
- Conditions
- Health Condition 1: J449- Chronic obstructive pulmonary disease, unspecified
- Registration Number
- CTRI/2019/07/020144
- Lead Sponsor
- Glenmark Pharmaceuticals Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 49
Inclusion Criteria
1. Hospitalized or Post-discharge cases of COPD
2. COPD cases with history of >=1 exacerbation in last year
3. Patients willing for follow-up visit.
Exclusion Criteria
1. Patients with < 1 follow up visit to be excluded from the analyses
2. Personal history of Bronchial asthma
3. Patients with history on use of oxygen therapy >12 hours/day
4. Patients with any history of unstable disease and/or recent hospitalization due to COPD prior to six weeks of study observation
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Assessment of <br/ ><br> <br/ ><br>1. Intergroup differences for percentage patients requiring Anticholinergics in Hospitalized or out-patient cases. <br/ ><br> <br/ ><br>2. Pre-bronchodilator PEFR or FEV1 improvement at 4 weeks. <br/ ><br> <br/ ><br>3. Change in CAT score at 4 weeks.Timepoint: 4 weeks
- Secondary Outcome Measures
Name Time Method Assessment of common adverse events (1%)Timepoint: 4 weeks.