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IRCT20140518017738N2 IRCT 2019-04-08 Ahvaz University of Medical Sciences Evaluating the effect of sildenafil on the treatment of severe asthma The effect of sildenafil on improvement of lung function and asthma attacks in patients with severe asthma 2018-09-23 anticipated 20 Complete https://irct.ir/trial/35125 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomized numbers from one to 20 was produced with a calculator, the first ten numbers allocated to intervention group and the other ten numbers allocated to control group.Then drug pockets sequentially from 1 to 20, was given to researcher for prescription to patients, Blinding description: All the drugs were in similar and dark pockets, there was one numerical label upon them. Only chemist was aware from specific number that allocated to specific group.Then drug pockets given to researcher to prescript and deliver to patients, sequential from one to 20. 3 Asthma. Intervention 1: Intervention group: This group received a single 50 mg dose of oral sildenafil (made in Ahvaz pharmacy faculty) daily during one month. Intervention 2: Control group: This group received a single 50 mg dose of oral placebo (made in Ahvaz pharmacy faculty) daily during one month. Yes - There is a plan to make this available What will be shared: Information on the main outcome or the like can be shared. When: Available access 6 months after the publication of results To whom: No Conditions: No Where to obtain: Mehrdad Dargahi Male Amir How to obtain: Communicate with the responsible person Comments:
public Mehrdad Dargahi Male Amir
Imam Khomeini Hospital., Azadegan Ave
Ahvaz Iran (Islamic Republic of) 6193673166 +98 61 3221 5574 dr_mehrdad_dargahi@yahoo.com Ahvaz University of Medical Sciences scientific Seyed Hamid Borsi
Imam Khomeini Hospital., Azadegan Ave
Ahvaz Iran (Islamic Republic of) 6193673166 +98 61 3221 5574 seyedhamidborsi@yahoo.com Ahvaz University of Medical Sciences Iran (Islamic Republic of) The patients with severe asthma no limit no limit Both Mild to moderate severity Using immunosuppressive drug and corticosteroid ( greater than 5 mg dose) outside the study protocol in three months ago Prohibition of phosphodiesterase inhibitors Nitrate consumption Pregnancy Advanced liver failure (liver cirrhosis) Advanced renal failure (CKD stage 4,5) Having any untreated disease such as reflux, sinusitis or allergic bronchopulmonary aspergillosis (ABPA) based on history and paraclinical tests which trigger asthma exacerbation continuously Uncontrolled hypertension J45 Asthma Treatment - Drugs Treatment - Drugs Intervention group: This group received a single 50 mg dose of oral sildenafil (made in Ahvaz pharmacy faculty) daily during one month. Control group: This group received a single 50 mg dose of oral placebo (made in Ahvaz pharmacy faculty) daily during one month. Lung Volume (Forced expiratory volume in one second); (FEV1). Timepoint: In the first referral and one month later. Method of measurement: spirometry. Lung Volume (Forced Vital Capacity); (FVC). Timepoint: In the first referral and one month later. Method of measurement: spirometry. Lung Volume (Forced Expiratory flow 25_75%); (FEF 25-75%). Timepoint: In the first referral and one month later. Method of measurement: spirometry. Forced expiratory volume in 1 second to forced vital capacity (FEV1/FVC). Timepoint: In the first referral and one month later. Method of measurement: spirometry. Quality of life score (upon quality of life questionnaire in asthmatic patients). Timepoint: In the first referral and one month later. Method of measurement: Questionnaire. Walking distance upon 6 minute walking distance test (meter). Timepoint: In the first referral and one month later. Method of measurement: Six minute walking distance test. Ahvaz University of Medical Sciences Approved 2018-09-22 Ethics committee of Ahvaz Jundishapur University of Medical Sciences Jundishapur University of Medical Sciences, Golestan Blvd., Golestan Town Ahvaz Khouzestan Iran (Islamic Republic of)