Study for the comparison of usefulness and quality of life of patients with airway disease after taking corticosteroid and bronchodilator drug combinatio
- Conditions
- Health Condition 1: J441- Chronic obstructive pulmonary disease with (acute) exacerbation
- Registration Number
- CTRI/2020/10/028365
- Lead Sponsor
- Department of Pharmacology
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1. Male and female patients of age 40 years or more.
2. Patient with at least 1 Inpatient Department visit with primary diagnosis for COPD (Spirometry: post bronchodilator- FEV1/FVC < 0.70).
3. Patient with at least 1 Emergency Department visit with COPD diagnosis.
4. Patient not having an exacerbation for one month prior to study entry.
5. Patient on inhalational therapy for 2-3 weeks.
1. Patient diagnosed with asthma or other non-COPD respiratory disorder.
2. Patient with history of any previous lung volume reduction surgery and/or lung transplantation.
3. Patient who requires oxygen therapy for at least 12 hours per day.
4. Any exclusionary co-morbid medical condition (cystic fibrosis, bronchiectasis, respiratory cancer, pulmonary fibrosis, pneumoconiosis, sarcoidosis), or any other condition likely to cause death within 3 years.
5. Current use of oral/injectable corticosteroid therapy.
6. Patients (diagnosed with cancer) who received >= 180 days of oral corticosteroids (OCS) in the 12 month pre-index period.
7. Immuno-compromised (HIV +ve) patients
8. Patients who are not willing to give written informed consent.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Comparison in exacerbation rate and SGRQ score in patients of COPD on Budesonide/Formoterol combination versus Fluticasone/Salmeterol combination.Timepoint: 2 week and 4 weeks
- Secondary Outcome Measures
Name Time Method To manage the side effects of both Budesonide/Formoterol combination and Fluticasone/Salmeterol combination in COPD patients.Timepoint: 2 week and 4 weeks