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IRCT201201028597N1 IRCT 2012-04-03 Massih Daneshvari hospital Ciclesonide comparison with fluticasone in mild persistent asthma Comparison between ciclesonide and fluticasone in patients with mild persistant asthma asthma 2011-11-22 anticipated 356 Complete https://irct.ir/trial/9103 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment. N/A Asthma. Intervention 1: Eligible patients are randomly divided to two groups and the intervention group patients will be assigned to receive ciclesonide 80mg once daily with spacer via inhalation. These patients will be educated in order to true spacer use. The patients never receive any other drugs related to asthma except salbutamol as rescue medication. Intervention 2: Eligible patients are randomly divided to two groups and the control group patients will be assigned to receive fluticasone 100 mg twice daily with spacer via inhalation. These patients will be educated in order to true spacer use. The patients never receive any other drugs related to asthma except salbutamol as rescue medication.
public
scientific Dr Seied Alireza Mahdaviani
Daraabd
Tehran Iran (Islamic Republic of) +98 21 2610 9930 arishah65@yahoo.com Massih Daneshvari Hospital Iran (Islamic Republic of) Iran (Islamic Republic of) Inclusion criteria: Ladies and gentlemen between 12 and 75 years as the definitive diagnosis of asthma is confirmed as mild persistent asthma: (Symptoms more than two days per week but less than daily incidence, symptoms at night more than two nights in month but less thatn every night, FEV1 ≥ 80% predicted, FEV1 Variability% 20 -% 30 and the use of B2 agonists short acting more than two days a week but less than daily). Exclusion criteria: A) Having any of the criteria for moderate persistent asthma B) Pregnancy - Breastfeeding C) sensitivity to corticosteroids D) other lung diseases like COPD E) use of systemic corticosteroids in acute asthma attacks during two months before the run in period 15 years 65 years Both J45.9 Asthma, unspecified Treatment - Drugs Treatment - Drugs Eligible patients are randomly divided to two groups and the intervention group patients will be assigned to receive ciclesonide 80mg once daily with spacer via inhalation. These patients will be educated in order to true spacer use. The patients never receive any other drugs related to asthma except salbutamol as rescue medication. Eligible patients are randomly divided to two groups and the control group patients will be assigned to receive fluticasone 100 mg twice daily with spacer via inhalation. These patients will be educated in order to true spacer use. The patients never receive any other drugs related to asthma except salbutamol as rescue medication. Forced expiratory volume in first second(FEV1). Timepoint: Before intervention and then 2,4, 8, 16 and 24 weeks after start of intervention. Method of measurement: Spirometry. Forced vital capacity(FVC). Timepoint: Before intervention and at 2, 4, 8, 16 and 24 th week and in any time that the patient was referred due to adverse events. Method of measurement: Spirometry. Number of asthma attacks. Timepoint: Any time it happened. Method of measurement: Recorded by patent himself/herself. Total score of mini AQLQ questionare. Timepoint: Before intervention and at 2, 4, 8, 16 and 24 th week and in any time that the patient was referred due to adverse events. Method of measurement: Questionare will be completed by patients. Nasopharyngitis as an adverse event. Timepoint: Before intervention and at 2, 4, 8, 16 and 24 th week and in any time that the patient was referred due to adverse events. Method of measurement: Physical examination and laboratory investigations if needed. Any adverse effect due to drug consumption. Timepoint: Before intervention and at 2, 4, 8,16 and 24 th week and in any time that the patient was referred due to adverse events. Method of measurement: Physical examination and laboratory investigations if needed. Massih Daneshvari hospital Approved 2011-11-19 National ethics committee in medical researches Enghelab Ave reasearch and technology branch of ministry of health Tehran Iran (Islamic Republic of)