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IRCT20210405050849N1 IRCT 2021-05-28 Shahre-kord University of Medical Sciences Evaluation of the effect of oral azithromycin on COPD patients Effects of Adding Azithromycin to Standard Outpatient and Inpatient COPD Treatment in Shahrekord University of Medical Sciences Hospitals 2021-06-22 anticipated 100 Complete https://irct.ir/trial/55468 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization will be done using the block method by a person who is not related to the study. Randomization of serial numbers of drug packages and placebo is done by a person who is not involved in the project and using a randomization table. The number of each package corresponds to the number of study patients, Blinding description: The two-way study is blind. Outcome assessors and participants are unaware of the type of grouping (intervention or placebo) (double-blind). Packages containing the drug and placebo are quite similar in shape and color. 2-3 Chronic Obstructive Pulmonary Disease. Intervention 1: Control group: Patients in the control group receive conventional therapy (triple therapy) and placebo. Triple therapy includes inhaled anticholinergics (long-acting, short-acting), inhaled bronchodilators (long-acting, short-acting), ICS ± oral corticosteroids (for two weeks). Intervention 2: Intervention group: In this group, in addition to triple therapy, patients are treated with oral azithromycin 250 mg daily made by Tehran Shimi Company for 2 months. Yes - There is a plan to make this available What will be shared: Only part of the data such as information about the main outcome or the like can be shared. When: 2021-2022 To whom: The data will be available only to researchers working in academic and scientific institutions Conditions: I have not decided yet Where to obtain: I have not decided yet How to obtain: I have not decided yet Comments:
public Ebrahim Abbasi Monjezi
Parastar aven
Sahrekord Iran (Islamic Republic of) 8816754633 +98 38 3222 0016 st-abbasi.e@skums.ac.ir Shahre-kord University of Medical Sciences scientific Ebrahim Abbasi Monjezi
Parastar Aven.Hajar Hospital
Shahrekord Iran (Islamic Republic of) 8816754633 +98 38 3222 0016 st-abbasi.e@skums.ac.ir Shahre-kord University of Medical Sciences Iran (Islamic Republic of) Diagnosis of COPD by an internal medicine physician, based on the classification of global pioneers of chronic obstructive pulmonary disease (GOLD) No other chronic diseases such as orthopedic and motor diseases, multiple sclerosis or cancer. hospitalization stability of the patient's physical and mental condition 40 years 70 years Both Lack of motivation of the patient to cooperation Immune system defects (recurrent respiratory infections and worsening of shortness of breath) Existence of concomitant asthma Complications of azithromycin non-pulmonary diseases like cancer; liver dysfunction, cholestatic jaundice, Infiltration and consolidation in chest x-ray Patients with acute exacerbation of COPD Existence of atopy or allergic rhinitis pneumonia embolism Kidney failure hearing loss J44.9 Chronic obstructive pulmonary disease, unspecified Treatment - Drugs Treatment - Drugs Control group: Patients in the control group receive conventional therapy (triple therapy) and placebo. Triple therapy includes inhaled anticholinergics (long-acting, short-acting), inhaled bronchodilators (long-acting, short-acting), ICS ± oral corticosteroids (for two weeks). Intervention group: In this group, in addition to triple therapy, patients are treated with oral azithromycin 250 mg daily made by Tehran Shimi Company for 2 months. FEV1/ FVC. Timepoint: Two months after starting the study. Method of measurement: Spirometry. Shahre-kord University of Medical Sciences Approved 2020-06-30 Ethics Committee of Shahrekord University of Medical Sciences Parastar Aven.Hajar Hospital Shahrekord Chahar-Mahal-va-Bakhtiari Iran (Islamic Republic of)