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IRCT20231219060463N1 IRCT 2024-01-16 Ahvaz University of Medical Sciences Azathioprine effect in severe asthmatic patients Comparison of the effectiveness of Azathioprine and placebo on lung volumes, exacerbations and severity of asthma in severe asthmatic patients 2024-02-09 anticipated 40 Complete https://irct.ir/trial/74605 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Using a calculator, random numbers from 1 to 40 are generated, 20 numbers and the first number generated by the calculator are assigned to the intervention group and the next 20 numbers to the control group, then the package of medicines is in the order of number 1 to 40 will be given to the researcher to administer to the patients, Blinding description: The study is double-blind, so that both the researcher and the participant do not know about the type of intervention (drug or placebo). All medicines are placed in similar and dark-colored packages, a numerical label is placed on the medicine box. Only the pharmacist is aware of the number assigned to the relevant group. Then, in order from number 1 to 40, the package of drugs is given to the researcher to prescribe to the patients. 3 Asthma. Intervention 1: Intervention group: Azathioprine, 2mg/kg daily tablets for 3 months، made in Ramopharmin pharmaceutical company. Intervention 2: Control group: Palcebo, with the same size and shape as azathioprine Produced in the central laboratory of Jundishapur University Faculty of Pharmacy, Ahvaz. Yes - There is a plan to make this available What will be shared: Demographic information of patients and paraclinical findings of patients in the form of patient code will be provided to other researchers in an unidentifiable manner. When: The access period starts 6 months after the results are published To whom: Other researchers who intend to conduct similar studies with a similar theme and topic Conditions: To conduct studies with a similar theme and topic Where to obtain: To get information, they can go to the office of the internal department of Imam Khomeini Hospital in Ahvaz, located on Azadegan Blvd. How to obtain: After submitting a written request for data request to the internal group office in Imam Khomeini Hospital of Ahvaz and validating the request through the group office, the data will be provided to the researcher after about two weeks. Comments:
public Mostafa Ajaman
Internal Medicine Office, Imam Khomeini Hospital, Azadegan Blvd.
Ahvaz Iran (Islamic Republic of) 6193673111 +98 61 3292 1839 ajaman.m@ajums.ac.ir Ahvaz University of Medical Sciences scientific Zahra Mehraban
Internal Medicine Office, Imam Khomeini Hospital, Azadegan Blvd.
Ahvaz Iran (Islamic Republic of) 6193673111 +98 61 3292 1839 mehraban.z@ajums.ac.ir Ahvaz University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Severe asthmatic patients (FEV1<60) diagnosed by pulmonologist No improvement in symptoms with usual treatments for asthma including Prednisolone 5mg/day, High dose inhaled corticosteroid, Long acting beta agonist and Long acting muscarinic antagonist 18 years 75 years Both Advanced liver failure Advanced renal failure Pregnancy Breastfeeding Cytopenia Moderate to severe anemia Known allergy to azathioprine Concomitant treatment with: Allopurinol, Febuxostat, Adalimumab, Anakinra Elevated liver enzymes (aminasemia) J45.5 Severe persistent asthma Treatment - Drugs Placebo Intervention group: Azathioprine, 2mg/kg daily tablets for 3 months، made in Ramopharmin pharmaceutical company Control group: Palcebo, with the same size and shape as azathioprine Produced in the central laboratory of Jundishapur University Faculty of Pharmacy, Ahvaz Mean forced expiratory volume in second 1. Timepoint: Before intervention and three months after intervention. Method of measurement: Spirometry. Mean Forced Vital Capacity (FVC). Timepoint: Before intervention and three months after intervention. Method of measurement: Spirometry. Mean forced expiratory flow at 25–75% of forced vital capacity. Timepoint: Before intervention and three months after intervention. Method of measurement: Spirometry. Mean asthma related questionnaire score. Timepoint: Before intervention and three months after intervention. Method of measurement: Asthma related questionnaire GSK 2002. The number of exacerbations. Timepoint: before intervention and three months after intervention. Method of measurement: History taking. Distance traveled in the 6-minute walking test. Timepoint: Before intervention and 3 months after intervention. Method of measurement: 6-minute walk test. Relative frequency of asthma recovery based on the forced expiratory volume in 1 second. Timepoint: At the end of the study. Method of measurement: Spirometer. Ahvaz University of Medical Sciences Approved 2023-12-18 Ethics committee of Ahvaz Jundiahapur University of Medical Sciences َِAhvaz Jundishapur University of Medical Sciences, Golestan Blvd., Golestan Town Ahvaz Khouzestan Iran (Islamic Republic of)