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Study of Montelukast in COPD

Investigating the effect of Montelukast drug on pulmonary function and clinical symptoms of patients with moderate to severe COPD

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
IRCT
Registry ID
IRCT20251108067917N1
Enrollment
62
Registered
2025-11-20
Start date
2025-11-16
Completion date
Unknown
Last updated
2025-12-08

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

Conditions

chronic obstructive pulmonary disease. Other chronic obstructive pulmonary disease

Interventions

Intervention 1: Intervention group: Receives Montelukast, manufactured by Zahravi Pharmaceutical Company, at a dose of one 10 mg oral tablet daily for two months. Intervention 2: Control group: Receiv

Sponsors

Ahvaz University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
40 Years to 70 Years

Inclusion criteria

Inclusion criteria: Patients aged 40 to 70 years Diagnosed with moderate to severe COPD Clinically stable over the past three months No history of hospitalization in the past six months Signed written informed consent

Exclusion criteria

Exclusion criteria: Patients with advanced cardiovascular disease, including EF less than 40% Rheumatologc diseases Uncontrolled hypertension Progressive kidney disease with a glomerular filtration rate (GFR) less than 30 mL/min Hypersensitivity to Montelukast

Design outcomes

Primary

MeasureTime frame
FEV1. Timepoint: One day before the intervention, and at two and four months after the start of the intervention. Method of measurement: Spirometer.;FVC. Timepoint: One day before the intervention, and at two and four months after the start of the intervention. Method of measurement: Spirometer.

Secondary

MeasureTime frame
FEF25–75%. Timepoint: One day before the intervention, and at two and four months after the start of the intervention. Method of measurement: Spirometer.;FEV1/FVC ratio. Timepoint: One day before the intervention, and at two and four months after the start of the intervention. Method of measurement: Spirometer.;The number of exacerbation episodes. Timepoint: Two and four months after the start of the intervention. Method of measurement: History taking.;Clinical improvement in dyspnea. Timepoint: One day before the intervention, and at two and four months after the start of the intervention. Method of measurement: The modified Medical Research Council questionnaire.;Clinical improvement in dyspnea. Timepoint: One day before the intervention, and at two and four months after the start of the intervention. Method of measurement: The chronic obstructive pulmonary disease assessment test.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMohsen Hajiani

Ahvaz University of Medical Sciences

mohsenhajiani@outlook.com+98 933 222 3291

Outcome results

None listed

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