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IRCT2016100930233N1 IRCT 2016-10-30 Vice chancellor for research,Tehran University of Medical Sciences Effect of nebulized Azithromycin in cystic fibrosis disease Comparing the efficacy of nebulized Azithromycin with oral Azithromycin in pulmonary function parameters in CF patients 2016-10-22 anticipated 50 Complete https://irct.ir/trial/24092 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment. N/A Cystic fibrosis. Intervention 1: In treatment group patients assigned to 28 days of treatment with 70 mg of nebulized AZT. Intervention 2: In control group patients assigned to 28 days of treatment with oral AZT every other day (250 mg for weight less than 40 kg and 500 mg for weight more than 40 kg).
public Dr. Andisheh Maneshi
Children Medical Center, Dr. Gharib st.
Tehran Iran (Islamic Republic of) +98 21 8800 5250 phamaneshi@gmail.com Children Medical Center scientific Dr Andisheh Maneshi
Tehran University of Medical Sciences, Faculty of pharmacy ,clinical pharmacist ward
Tehran Iran (Islamic Republic of) +98 21 8800 5250 phamaneshi@gmail.com; a-maneshi@razi.tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Patients enrolled into the study were: 8 to18 years old with a documented CF diagnosis (sweat tests more than 60 mEq/L at least two times) and had moderate-to-severe lung disease (FEV1 _ 25% to _ 75% predicted) and PA airway infection (documented at screening or two times within previous year; including once within the previous 3 months) not recent (ie, day _28 to screening) administration of inhaled, IV, or oral antipseudomonal antibiotics, not administration of oral Azithromycin at least for two months ( 2 months wash out or has not administered yet or stop taking oral Azithromycin at least for 2 months ). Exclusion criteria: current oral corticosteroid, lung transplantation; recent changes in antimicrobial, bronchodilator, antiinflammatory, or corticosteroid medications, or physiotherapy technique/ schedule; smear-positive sputum for non- Mycobacterium tuberculosis. 8 years 18 years Both E84.0 Cystic fibrosis with pulmonary manifestations Treatment - Drugs Treatment - Drugs In treatment group patients assigned to 28 days of treatment with 70 mg of nebulized AZT In control group patients assigned to 28 days of treatment with oral AZT every other day (250 mg for weight less than 40 kg and 500 mg for weight more than 40 kg). Pseudomonas aeruginosa colony count. Timepoint: screening, Baseline,+28 day Treatment. Method of measurement: sputum Test and culture. FEV1. Timepoint: screening, Baseline,+28 day Treatment. Method of measurement: spirometry. Pseudomonas aeruginosa phenotype. Timepoint: Screeninig, Baseline,+28 day Treatment. Method of measurement: sputum Test and culture. Pseudomonas aeruginosa resistance pattern. Timepoint: Screeninig, Baseline,+28 day Treatment. Method of measurement: sputum Test and culture. Vice chancellor for research,Tehran University of Medical Sciences Approved 2015-12-15 Tehran University of Medical Sciences Tehran University of Medical Sciences, Keshavarz Blvd. Tehran Iran (Islamic Republic of)