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 个研究点目标入组 0 人开始时间: 待定最近更新: 2024年1月22日

试验速览

暂无简介。

•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.

•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.

发起方

Dr Saurabh Mittal