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IRCT20191211045703N1 IRCT 2020-06-24 Iran University of Medical Sciences Comparison of the efficay and side effects of nebulized oral pulmicort and inhaler budesonide in patients with eosinophilic esophagitis Investigation and comparison of the efficacy and side effects of only nebulized oral Pulmicort and only inhaled budesonide and diet with oral budesonide nebul in patients aged one to 18 years with eosinophilic esophagitis 2020-02-04 anticipated 60 Complete https://irct.ir/trial/44589 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: For this purpose, the random allocation law method was used. In random allocation (based on probability principles) eliminates the link between intervention and potential distortion.Random allocation was used by variable block method.The randomization unit was individual.In this way, a set of 60 cards was prepared, which included three 20-block blocks of three types of cards A, B, and C, which were randomly and randomly removed for each person by the researcher. The collection could not be returned, Blinding description: Due to the fact that this study did not have a placebo and the drug form used was completely different. Only the data analyst did not know which group the recorded clinical information belonged to. N/A eosinophilic esophagitis. Intervention 1: Intervention group: nebulized oral pulmicort.Palmicortic is a drug containing budesonide and belongs to the corticosteroids, which are commonly used to reduce and prevent inflammation and swelling in the lungs and asthma.The drug is manufactured by ASTRAZENECA from Sweden. Patients in pulmicort group less than 20 kg will receive 0.5 mg/dose/day, while those over 20 kg will receive 1 mg/dose/day for 8 weeks. In case there is no improvement in the disease after 8 weeks, patients fewer than 20 kg will receive 1mg/dose/day and those over 20 kg will receive 2 mg/dose/day. Patients will be followed-up on the 4th, 8th, 12th, and 16th weeks. Intervention 2: Intervention group: inhaler budesonide.An inhaled drug containing budesonide belongs to the corticosteroids, which are commonly used to reduce and prevent inflammation and swelling in the lungs and asthma. Each prescription contains 2 ml of sterile solution.This solution must be turned into steam for inhalation in a special device.Patients in the budesonide spray group will receive 1 puff twice daily. In case no efficacy is observed, patients will receive 2 puffs twice daily for 8 weeks. Patients will then be monitored and evaluated on 4th, 8th, 12th and 16th weeks. Intervention 3: Control group: diet without drug. In this group patients will not receive any type of drug intervention. Yes - There is a plan to make this available What will be shared: Documents and information of demographic data, clinical and pathological findings of all patients will be shared, but personal data are will not be shared. When: At the end of study and after publication of article To whom: University researchers physicians pharmacologists Conditions: Medical researcher can use data after getting admission from all members of this study for further research Where to obtain: They should contact with Dr. Nastaran Amiri How to obtain: They should initially contact with Dr. Nastaran Amiri to get permission Comments:
public Nastaran Amiri
Zafar street, Ali Asghar Hospital
Tehran Iran (Islamic Republic of) 1919816766 +98 21 2222 2041 drnastaranamiri@gmail.com Iran University of Medical Sciences scientific Nastaran Amiri
Zafar street, Ali Asghar Hospital
Tehran Iran (Islamic Republic of) 1919816766 +98 21 2222 2041 drnastaranamiri@gmail.com Iran University of Medical Sciences Iran (Islamic Republic of) Pediatric patients with eosinophilic esophagitis consent form parents proton pump consumption Adherence to the treatment protocols of this study 1 year 18 years Both history of systemic corticosteroids drugs using history of systemic underlying diseases Adrenal insufficiency history K20.0 Eosinophilic esophagitis Treatment - Drugs Treatment - Drugs Lifestyle Intervention group: nebulized oral pulmicort.Palmicortic is a drug containing budesonide and belongs to the corticosteroids, which are commonly used to reduce and prevent inflammation and swelling in the lungs and asthma.The drug is manufactured by ASTRAZENECA from Sweden. Patients in pulmicort group less than 20 kg will receive 0.5 mg/dose/day, while those over 20 kg will receive 1 mg/dose/day for 8 weeks. In case there is no improvement in the disease after 8 weeks, patients fewer than 20 kg will receive 1mg/dose/day and those over 20 kg will receive 2 mg/dose/day. Patients will be followed-up on the 4th, 8th, 12th, and 16th weeks. Intervention group: inhaler budesonide.An inhaled drug containing budesonide belongs to the corticosteroids, which are commonly used to reduce and prevent inflammation and swelling in the lungs and asthma. Each prescription contains 2 ml of sterile solution.This solution must be turned into steam for inhalation in a special device.Patients in the budesonide spray group will receive 1 puff twice daily. In case no efficacy is observed, patients will receive 2 puffs twice daily for 8 weeks. Patients will then be monitored and evaluated on 4th, 8th, 12th and 16th weeks. Control group: diet without drug. In this group patients will not receive any type of drug intervention. The effect of oral Budesonide nebulizer on improving Eosinophilic Esophagitis. Timepoint: Patients in the oral Budesonide nebulizer group will receive 1 puff twice a day.If the effectiveness of the drug is not observed after 8 weeks, patients will receive 2 puffs twice a day.Then during weeks 4,12,8 and 16 patients will be followed up and examined. Method of measurement: At the beginning of the study and after the 16th week, patients will be re-examined for histological and tissue pathology, as well as blood eosinophil counts and cortisol examination by Enzyme-linked immunosorbent test at 8 a.m.There will also be a routine laboratory test, such as hematology and biochemistry. Iran University of Medical Sciences Approved 2019-11-26 Ethics committee of Iran University of Medical Sciences Zafar Street, Ali Asghar Hospital tehran Tehran Iran (Islamic Republic of)