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IRCT20251108067917N1 IRCT 2025-11-20 Ahvaz University of Medical Sciences Study of Montelukast in COPD Investigating the effect of Montelukast drug on pulmonary function and clinical symptoms of patients with moderate to severe COPD 2025-11-16 anticipated 62 Complete https://irct.ir/trial/87393 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization method and description: Balanced block randomization. Unit of randomization: Individual participant. Stratification layers (if stratified randomization is used): Not applicable. Randomization tool: The sequence of drug and placebo allocation is determined using statistical software and predefined block sizes. Random sequence generation: Drug and placebo packages are identical in appearance and labeled with sequential numbers according to the randomization list. These are provided to the designated unit/person responsible for dispensing the intervention, to be distributed in order to participants enrolled in the study. Allocation concealment: The randomization list is prepared in duplicate and kept by an individual not involved in the study and not present at the study site. During data analysis, only two groups labeled A and B are provided to the analyst. The identity of the drug and placebo groups is revealed only after completion of the analysis and summary of results, Blinding description: Since the placebo in this study is manufactured and provided by the producing company, there is no visual difference between what is given to the dispenser and the patient. Therefore, there is no way for the outcome assessor, data analyst, or even members of the safety and data monitoring committee to identify the type of intervention. All parties remain blinded to whether the patient receives the active drug or the placebo. 2 chronic obstructive pulmonary disease. 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: Receives placebo for two months. The placebo is manufactured by Jundishapur Faculty of Pharmacy. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is The release of participant data is subject to the policies of the university and the affiliated educational-treatment department, which are the primary intellectual owners of the research project.
public Mohsen Hajiani
Sina Building, Corner of Esfahan Street and Eqbal Street
Ahvaz Iran (Islamic Republic of) 6193673166 +98 933 222 3291 mohsenhajiani@outlook.com Ahvaz University of Medical Sciences scientific Seyed Hamid Borsi
Sina Building, Corner of Esfahan Street and Eqbal Street
Ahvaz Iran (Islamic Republic of) 6193673166 +98 61 3292 1839 borsi-h@ajums.ac.ir Ahvaz University of Medical Sciences Iran (Islamic Republic of) 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 40 years 70 years Both 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 J44 Other chronic obstructive pulmonary disease Treatment - Drugs Placebo Intervention group: Receives Montelukast, manufactured by Zahravi Pharmaceutical Company, at a dose of one 10 mg oral tablet daily for two months. Control group: Receives placebo for two months. The placebo is manufactured by Jundishapur Faculty of Pharmacy. 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. 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. Ahvaz University of Medical Sciences Approved 2025-07-26 Research Ethics Committees of Ahvaz Jundishapour University of Medical Sciences Ground Floor, Office of Research and Technology Ahvaz Jundishapur University of Medical Sciences University Campus اهواز Khouzestan Iran (Islamic Republic of)