A study for the uses and side effects of corticosteroids and bronchodilator drugs in people with airway problems

Not Applicable

Conditions: Health Condition 1: J449- Chronic obstructive pulmonary disease, unspecified

Registration Number: CTRI/2019/10/021728

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

Inclusion Criteria

1. Patient age more than 40 years.

2. At least 1 inpatient visit with a primary diagnosis for COPD (Spirometry: post bronchodilator- FEV1/FVC < 0.70).

3. At least 1 ED visit with a COPD diagnosis (either primary or secondary).

4. Patient not having an exacerbation for one month prior to study entry.

5. Patient on inhalational therapy â?? 2-3 weeks.

Exclusion Criteria

1. Patient diagnosed with asthma or other non-COPD respiratory disorder.

2. Any previous lung volume reduction surgery AND/OR lung transplantation.

3.A requirement for 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. Patients who initiated both study medications on the same date.

8. Immuno-compromised (HIV +ve) patients

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in Spirometric indices (FEV1,FVC and FEV1/FVC) of COPD patients on Budesonide/formoterol combination versus Fluticasone /salmeterol combination.Timepoint: Baseline and 4 weeks

Secondary Outcome Measures