A randomized controlled trial to assess the efficacy of double vs single drug containing inhaler in patients with symptomatic lung disease after tuberculosis

Phase 3

Conditions: Health Condition 1: J988- Other specified respiratory disorders

Registration Number: CTRI/2023/12/060591

Lead Sponsor: Dr Saurabh Mittal

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Yet Recruiting

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

1. Age > 18 years and providing written informed consent.

2. Patients with a history of microbiologically or clinico-radiologically diagnosed and treated pulmonary tuberculosis; treatment completed at least 6 months before randomization.

3. Having symptoms in the form of cough and/ or shortness of breath [modified Medical Research Council (mMRC) dyspnea grade ?2].

4. Having chest radiographic or CT thorax abnormalities consistent with post-tuberculosis lung disease or having spirometry abnormalities in the form of post-bronchodilator FEV1 <80% of predicted.

Exclusion Criteria

1. Active tuberculosis (primary or relapse).

2. A history of cystic fibrosis, asthma, bronchiectasis, ILD, COPD, Occupational lung diseases, or smoking history >10 pack-years.

3. Acute exacerbations requiring usage of oral or inhalation steroids or short- and long-acting anticholinergics within 6 weeks before randomization.

4. History of chest surgery, myocardial infarction, and hospitalization due to any heart disease within the last 3 months before randomization.

5. Unstable cardiac arrhythmia, narrow-angle glaucoma, and symptomatic prostatic hyperplasia.

6. Known allergies to study medications.

7. Pregnant females or planning pregnancy during the study.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To compare the change (from baseline) in pre-bronchodilator FEV1 (% predicted) between the two groups at 12 weeks.Timepoint: To compare the change (from baseline) in pre-bronchodilator FEV1 (% predicted) between the two groups at 12 weeks.

Secondary Outcome Measures

Name	Time	Method
To compare the change in inflammatory biomarkers from baseline to 12 weeks between the two groups.Timepoint: 12 weeks;To compare the change in SGRQ from baseline to 12 weeks between the two groups.Timepoint: 12 weeks;To compare the change in the CAT score from baseline to 12 weeks between the two groups.Timepoint: 12 weeks;To compare the change in VO2 max (the maximum oxygen uptake per minute, as assessed by CPET) from baseline to 12 weeks between the two groups.Timepoint: 12 weeks