CTRI/2023/12/060591
Not yet recruiting
Phase 3
A randomized controlled trial to assess the efficacy of inhaled Formoterol/ Glycopyrronium combination (LABA+LAMA) vs inhaled Glycopyrronium (LAMA) alone in patients with symptomatic Post Tubercular lung disease - NI
Dr Saurabh Mittal0 sites0 target enrollmentTBD
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Health Condition 1: J988- Other specified respiratory disorders
- Sponsor
- Dr Saurabh Mittal
- Status
- Not yet recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Not specified
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