A clinical study to evaluate efficacy and safety of inhaled corticosteroids in mild to moderate cases of Chronic Obstructive Pulmonary Disease
Phase 4
Completed
- Conditions
- Health Condition 1: null- Chronic Obstructive Pulmonary DiseaseHealth Condition 2: J441- Chronic obstructive pulmonary disease with (acute) exacerbation
- Registration Number
- CTRI/2011/091/000182
- Lead Sponsor
- Research project grant of Government of Gujarat
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 60
Inclusion Criteria
Age between 35 to 70 years of either sex
Clinically diagnosed mild to moderate COPD as per GOLD guideline (FEV1 more than 50 FEV1 and FVC ratio less than 0.7)
Ability to give written informed consent
Smokers and ex-smokers more and equal to 10 pack per years
Exclusion Criteria
Patients on oral steroid
History Of significant illness of other system especially cardiovascular system
History of exacerbation in run in period
Patients having other serious respiratory illness ( tuberculosis asthma) other than COPD
History of long acting antihistaminic within 1 week
History of Hypersensitivity to study medications
Contraindication to six minute walk test
Do not give informed consent
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Pulmonary function test (FEV1 and FVC)Timepoint: Prospective
- Secondary Outcome Measures
Name Time Method Six minute walk distance (6MWD)Timepoint: Prospective