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Clinical Trials/CTRI/2023/12/060591
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.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional

Investigators

Sponsor
Dr Saurabh Mittal

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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