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

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 - NIL

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/12/060591

Enrollment

Registered

2023-12-20

Start date

Unknown

Completion date

Unknown

Last updated

2024-01-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: J988- Other specified respiratory disorders

Interventions

Intervention1: Inhaled Formoterol/ Glycopyrronium (25+12mcg) combination (LABA+LAMA): Dry powder inhaler twice daily for 12 weeks Control Intervention1: Inhaled Glycopyrronium (50 mcg) (LAMA): Dry pow

Eligibility

Inclusion 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

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.

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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	—

Measure

Time frame

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

—

Countries

India

Contacts

Public ContactSaurabh Mittal

All India Institute of Medical Sciences, New Delhi

saurabh_kgmu@yahoo.co.in01126546357

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026