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IRCT20181225042116N1 IRCT 2020-12-18 Islamic Azad University Comparison effects of Itraconazole and Prednisone in patients with persistent severe asthma Comparison effects of Itraconazole and Prednisone on Fibroblast Growth Factor 2 gene expression, clinical manifestation and other tests in patients with persistent severe asthma 2020-12-21 anticipated 70 Complete https://irct.ir/trial/41988 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Assignment of individuals to study groups is a block randomization method using 7 blocks of 10; This is done with stata software version 16, this software generates random groups, each block has 5 people in the intervention group and 5 people in the control group, whose order is also random and the numbers assigned to each person are different then labeled onto medicine boxes that have the same shape , and all ten drugs that belong to a block are placed in a separate package, and one is randomly picked and given to the patient, Blinding description: All drugs, both prednisone and itraconazole, have been purchased from the pharmaceutical company in the form of a pure white substance. Then, the drugs are filled in capsules of the same size and color with the cooperation of Mashhad School of Pharmacy; medicine cans are packed in the same shape with the same drug label, random numbers are pasted on them and placed in packs of 10 that are already divided into blocks, then these packages are transferred to a specialized asthma clinic.then nurse is given a can of medicine to the patient after the doctor's examination and being included in the criteria for studying.At the end of each course of the drug, the same can of medicine with the previous code is given again until the end of the study. Also, the person entering the information in Excel enters all the patient information only according to the code on the medicine. During the study, none of the people are aware of the type of medicine used. At the end of the study, the person who had no role in the study is asked to Assign 1 and 2 to the table of random numbers for each drug that can be analyzed for statistics without knowing the drug. 2-3 Asthma. Intervention 1: The first intervention group: Itraconazole capsules 100 mg twice a day for 8 months Tehran Daru company. Intervention 2: Control group: prednisone tablets 5 mg twice a day for 8 months Iran Hormone company. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is No more information
public Mahsa Manafi Varkiani
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Mashhad Iran (Islamic Republic of) 9197948937 +98 51 3605 5216 mahsafall_2005@yahoo.com Islamic Azad University scientific Majid Mirsadraee
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mashhad Iran (Islamic Republic of) 91977958963 +98 51 3605 5216 mahsafall_2005@yahoo.com Islamic Azad University Iran (Islamic Republic of) Age older than 18 years old No response to high dose inhaled corticosteroids and long acting beta agonist with antileukotriene Forced expiratory volume in one second less than 80 percent Fungal sensitization 18 years no limit Both Sensitivity and drug interaction with Itraconazole History of taking Itraconazole Gastroesophageal reflux disease Known and untreated Severe heart disease Known liver and kidney disease Chronic eosinophilic pneumonia Charge Strauss syndrome Chronic Obstructive Pulmonary Disease Total IgE more than 1000IU/ml Pregnancy or breastfeeding Lack of access to Appropriate RNA in patient sputum sample Sarcoidosis Hypersensitivity pneumonitis Impaired vocal cords Filarisis Central airway obstruction Sleep apnea J45.5 Severe persistent asthma Treatment - Drugs Treatment - Drugs The first intervention group: Itraconazole capsules 100 mg twice a day for 8 months Tehran Daru company Control group: prednisone tablets 5 mg twice a day for 8 months Iran Hormone company Fibroblast growth factor2 gene expression measurement. Timepoint: Measuring fibroblast growth factor 2 gene expression before intervention and 8 months after taking Itraconazole drug or prednisone. Method of measurement: Real time Polymerase Chain Reaction. Number of sputum eosinophils and neutrophils. Timepoint: Before intervention and 8 months after treatment. Method of measurement: Preparation of thin smear after sputum centrifugation with DDT 0.01%, and staining with hematoxin and eosin and counting with light microscope. Bronchial size changes include bronchial thickness, internal lumen, external lumen, wall area percentage. Timepoint: Before intervention and 8 months after treatment. Method of measurement: Chest High-resolution computed tomography. Spirometric parameters include FEV1, FVC, Fef25-75. Timepoint: Before intervention and 8 months after treatment. Method of measurement: Spirometer device. Measurement of fractional nitric oxide concentration in exhaled breath. Timepoint: Before the intervention and after 8 months of treatment. Method of measurement: Bedfont NO breath device for Measuring nitric oxide. Asthma Symptom Questionnaire. Timepoint: Before the intervention and after 8 months of treatment. Method of measurement: Asthma control questionnaire (ACQ). Clinical symptoms of patients include wheezing. Timepoint: Before the intervention and after 2 weeks, then every month until the end of the treatment period. Method of measurement: According to the examination by stethoscope. Islamic Azad University Approved 2020-08-05 Ethics committee of Central Organization of Islamic Azad University Bazarche Sarab Ave.,Imam Khomeini Blvd, Mashhad Razavi Khorasan Iran (Islamic Republic of)