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IRCT20091111002695N8 IRCT 2019-05-19 Islamic Azad University Effect of Azithromycin in refractory asthma The effect of Azithromycin on airways remodeling in patients with severe refractory asthma 2019-06-05 anticipated 75 Complete https://irct.ir/trial/39513 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The “Block” randomization method was used to make three treatment groups with block size of 25 for each. Unit of randomization is “individual”. Blocks are then randomly chosen to determine the patients’ assignment into the groups (Azithromycin, Prednisolone and Placebu). The tool used for randomization was “www. Randomizer.org” website which uses “Math.random” method within the javaScript programming language to generate its random numbers. Allocation concealment: coded drug containers of identical appearance prepared by an independent group, Blinding description: All the drugs will be prepared with united shape, color and packages. the only difference is the code on the package. The drugs will be given to our colleague who is present in the clinic everyday and is blinded to the types of the drugs and groups of treatment. Each time the patients refer to our clinic they will receive the same drug based on their randomized code. 2-3 Severe persistent asthma. Intervention 1: Intervention group1: Azithromycin 250mg in form of soft gelatin capsule, one each 12 hours, for 8 months. The Active Pharmaceutical Ingredient is provided by Farabi Pharmaceutical company. Intervention 2: Intervention group2: Prednisoline 5mg in form of soft gelatin capsule, one each 12 hours, for 8 months. The Active Pharmaceutical Ingredient is provided by Alborz Bulk Company. Intervention 3: Control group: Placebo in form of soft gelatin capsule containing Lactose, one each 12 hours, for 8 months. Yes - There is a plan to make this available What will be shared: Age Gender Asthma Duration Need for Emergency medical services ( before and after treatment) ACT Score ( before and after treatment) FEV1 ( before and after treatment) FENO( before and after treatment) Bronchial wall thickness in lung CT-scan( before and after treatment) TGF-beta gene expression ( before and after treatment) When: One Month after publishing the results. To whom: There will be no limitation for accessing the data. Conditions: There will be no limitation for accessing the data. If someone need to use the data, he/she might ask the corresponding author for permission. Where to obtain: Contact the corresponding author. How to obtain: After contacting the corresponding author via phone or Email, the data will be provided. Comments:
public Majid Mirsadraei
No 80, 15th Kosar, Kosar Ave., Vakilabad Blv.
Mashhad Iran (Islamic Republic of) 9187147578 +98 51 3870 4347 majidmirsadraee@mshdiau.ac.ir Islamic Azad University scientific Majid Mirsadraei
No 80, 15th Kosar, Kosar Ave., Vakilabad Blv.
Mashhad Iran (Islamic Republic of) 9187147578 +98 51 3870 4347 majidmirsadraee@mshdiau.ac.ir Islamic Azad University Iran (Islamic Republic of) Patients suffering from severe refractory asthma who could not be controlled by high dose corticosteroids and long acting beta2 agonists or by antileukotrienes with or without tiotropium. FEV1 must be less than 80 percent. 18 years no limit Both Allergic bronchopulmonary aspergillosis Drug allergy Pregnancy or Breast milk feeding Interstitial lung disease such as Vasculitis Recent lung infection Gastroesophageal reflux J45.5 Severe persistent asthma Treatment - Drugs Treatment - Drugs Treatment - Drugs Intervention group1: Azithromycin 250mg in form of soft gelatin capsule, one each 12 hours, for 8 months. The Active Pharmaceutical Ingredient is provided by Farabi Pharmaceutical company. Intervention group2: Prednisoline 5mg in form of soft gelatin capsule, one each 12 hours, for 8 months. The Active Pharmaceutical Ingredient is provided by Alborz Bulk Company. Control group: Placebo in form of soft gelatin capsule containing Lactose, one each 12 hours, for 8 months. Bronchial Wall thickness. Timepoint: Before intervention and 8 months after intervention. Method of measurement: Computed tomography (CT) Scan of lung. Transforming growth factor beta (TGF-beta) gene expression. Timepoint: Before intervention and 8 months after intervention. Method of measurement: Detecting by Polymerase chain reaction (PCR) of the Sputum. Expiratory nitric oxide test with NObreath equipment. Timepoint: Before intervention and 8 months after intervention. Method of measurement: Expiratory nitric oxide test with NObreath equipment. Forced expiratory volume in one second (FEV1). Timepoint: Before intervention and 8 months after intervention. Method of measurement: Micro medical spirometer. Asthma control. Timepoint: Before intervention and 8 months after intervention. Method of measurement: Asthma Control Test (ACT) score. Number of Need for emergency services because of asthma exacerbation. Timepoint: Before intervention and 8 months after intervention. Method of measurement: Recording the date of asthma exacerbation in the Special Card which will be given to the patients. Islamic Azad University Approved 2019-05-01 Ethics committee of Islamic Azad University- Mashhad branch Shahin Far Building, sarab alley, Azadi street Mashhad Razavi Khorasan Iran (Islamic Republic of)