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IRCT201104236257N1 IRCT 2011-05-25 Arak University of Medical Sciences Effect of statins in treating patients with asthma Atrvastatyn effect in treating patients with asthma 2010-10-24 anticipated 31 Complete https://irct.ir/trial/6692 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment. 0 (exploratory trials) Asthma. Intervention 1: 31 patients were selected as intervention group and treat with atorvastatin tablets (by: Sobhan Pharmaceutical Company) 40 milligram daily for 8 weeks . At the begining of the study after obtaining formal consent, the standard questionnaire of asthma control test (ACT) is filled out and followed by a spirometry; also a peripheral blood sample is taken to measure blood eosinophil counts and patients’ serum low density lipoprotein-cholesterol(LDL-C), low density lipoprotein-cholesterol (HDL-C), total cholesterol, and TG levels. Serum cholesterol and TG measurement tests is applyied to evaluate the adherence of the patients. For spiromety, Desktop spirometer device, Pony FX model, made in Italy is used. Four weeks after treatment,asthma control test (ACT) questionnaire will be re-administered and the patients visit for possible side effects of drugs and asthma control level. Finally, after 8 weeks of treatment, the patiants took the asthma control test (ACT) questionnaire, and a spirometry is taken from patients. Also, another peripheral blood sample is taken to determine changes in the peripheral blood eosinophil count and serum cholesterol and TG levels. Intervention 2: 31 patients were selected as Control group and receive placebo daily for 8 weeks . At the begining of the study after obtaining formal consent, the standard questionnaire of asthma control test (ACT) is filled out and followed by a spirometry; also a peripheral blood sample is taken to measure blood eosinophil counts and patients’ serum low density lipoprotein-cholesterol(LDL-C), low density lipoprotein-cholesterol (HDL-C), total cholesterol, and TG levels. For spiromety, Desktop spirometer device, Pony FX model, made in Italy is used. Four weeks after treatment,asthma control test (ACT) questionnaire will be re-administered and the patients visit for asthma control level. Finally, after 8 weeks of treatment, the patiants took the asthma control test (ACT) questionnaire, and a spirometry is taken from patients. Also, another peripheral blood sample is taken to determine changes in the peripheral blood eosinophil count and serum cholesterol and TG levels.
public Dr. Abdollatif Moini
Iran Internal Medicin Department of Amir-al-momenin Haspital
Arak Iran (Islamic Republic of) +98 86 1222 5202 dr.moini@arakmu.ac.ir Arak University of Medical Sciences scientific Dr. Abdollatif Moini
internal Medicine Department of Amir-al-momenin Haspital- Arak- Iran
Arak Iran (Islamic Republic of) +98 86 1222 5202 dr.moini@arakmu.ac.ir Arak University of Medical Sciences Iran (Islamic Republic of) Inclusion criteria included: patients with mild persistent to moderate persistent asthma (grade 2 and 3 criteria, the severity of asthma), age 18 to 70 years and acceptance of written consent. Exclusion criteria included: pregnancy, people who currently are taking statin drugs , history of sensitivity to statin drugs, History of hospitalization during a month before the research, smokers, history of hepatitis or active liver disease ,myopathy or myositis 18 years 70 years Both J45.9 Asthma, unspecified Treatment - Drugs Treatment - Drugs 31 patients were selected as intervention group and treat with atorvastatin tablets (by: Sobhan Pharmaceutical Company) 40 milligram daily for 8 weeks . At the begining of the study after obtaining formal consent, the standard questionnaire of asthma control test (ACT) is filled out and followed by a spirometry; also a peripheral blood sample is taken to measure blood eosinophil counts and patients’ serum low density lipoprotein-cholesterol(LDL-C), low density lipoprotein-cholesterol (HDL-C), total cholesterol, and TG levels. Serum cholesterol and TG measurement tests is applyied to evaluate the adherence of the patients. For spiromety, Desktop spirometer device, Pony FX model, made in Italy is used. Four weeks after treatment,asthma control test (ACT) questionnaire will be re-administered and the patients visit for possible side effects of drugs and asthma control level. Finally, after 8 weeks of treatment, the patiants took the asthma control test (ACT) questionnaire, and a spirometry is taken from patients. Also, another peripheral blood sample is taken to determine changes in the peripheral blood eosinophil count and serum cholesterol and TG levels. 31 patients were selected as Control group and receive placebo daily for 8 weeks . At the begining of the study after obtaining formal consent, the standard questionnaire of asthma control test (ACT) is filled out and followed by a spirometry; also a peripheral blood sample is taken to measure blood eosinophil counts and patients’ serum low density lipoprotein-cholesterol(LDL-C), low density lipoprotein-cholesterol (HDL-C), total cholesterol, and TG levels. For spiromety, Desktop spirometer device, Pony FX model, made in Italy is used. Four weeks after treatment,asthma control test (ACT) questionnaire will be re-administered and the patients visit for asthma control level. Finally, after 8 weeks of treatment, the patiants took the asthma control test (ACT) questionnaire, and a spirometry is taken from patients. Also, another peripheral blood sample is taken to determine changes in the peripheral blood eosinophil count and serum cholesterol and TG levels The expected primary outcome was improvement in the degree of clinical control of asthma symptoms [base on standardized Asthma Control Test (ACT)]. Timepoint: At the onset of the study and 8 week after treatment with atorvastatin. Method of measurement: base on standardized Asthma Control Test (ACT). Secondary outcomes included lung volumes [percent of forced expiratory volume in one second (FEV1 %) and percent of forced vital capacity (FVC%)] and reduction of the number of peripheral blood eosinophils. Timepoint: At the onset of the study and 8 week after treatment with atorvastatin. Method of measurement: spirometry and peripheral blood sample. Arak University of Medical Sciences Approved 2010-09-23 Medical Ethics committee of Arak University of Medical Sciences Arak University of Medical Sciences Arak Iran (Islamic Republic of)