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IRCT20170531034256N2 IRCT 2019-05-27 Shahid Beheshti University of Medical Sciences Effectiveness of the Treatment With Budesonide Nebuliser among Patients with Acute Asthma The effectiveness of the Treatment With Budesonide Nebuliser among Patients with Acute Asthma 2019-03-21 anticipated 70 Complete https://irct.ir/trial/37343 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Individuals are randomly assigned to one of two study groups with the help of a random number table and receive the intervention of the same group, Blinding description: *A statistician will classify the patients based on the random numbers in either group one (control group) or group 2 (intervention group). This person is unaware of the type of treatment which they will receive in each group. * Patients will be informed about two potential types of treatment but they won't know they will receive which of those. * The nurse will give the patients' unlabeled medicine based on their code. 3 Asthma. Intervention 1: Intervention group: On arrival, PEF of all individuals will be evaluated. The so-called intervention group will receive Oxygen, the spray containing Salbutamol and Ipratropium bromide, corticosteroids in the form of hydrocortisone based on Gina guideline in addition to budesonide (at the arrival, 0.5-ml budesonide will be taken and this will be repeated every 30 minutes for three times) using a nebulizer. Intervention 2: Control group: On arrival, PEF of all individuals will be evaluated. The so-called control group will receive Oxygen, the spray containing Salbutamol and Ipratropium bromide, corticosteroids in the form of hydrocortisone based on Gina guideline in addition to distilled water (at the arrival, 0.5-ml distilled water will be taken and this will be repeated every 30 minutes for three times) using a nebulizer. 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 Fatemeh Razavi
Masih Daneshvari Hospital, Darabad Avenue, Shahid Bahonar roundabout,
Tehran Iran (Islamic Republic of) 19569-44413 +98 21 2712 2031 Fatemehrazavi@sbmu.ac.ir Shahid Beheshti University of Medical Sciences scientific Arda Kiani
Masih Daneshvari Hospital, dar abad
Tehran Iran (Islamic Republic of) 19569-44413 +98 21 2712 2031 ardakiani@sbmu.ac.ir Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Definitive diagnosis of asthma being older than 18 18 years no limit Both the Flu Patients who are treated with other forms of medication Pregnant patients obvious infection in Chest X-ray Patient with heart , kidney, liver disease J45.21 Mild intermittent asthma with (acute) exacerbation Treatment - Drugs Placebo Intervention group: On arrival, PEF of all individuals will be evaluated. The so-called intervention group will receive Oxygen, the spray containing Salbutamol and Ipratropium bromide, corticosteroids in the form of hydrocortisone based on Gina guideline in addition to budesonide (at the arrival, 0.5-ml budesonide will be taken and this will be repeated every 30 minutes for three times) using a nebulizer. Control group: On arrival, PEF of all individuals will be evaluated. The so-called control group will receive Oxygen, the spray containing Salbutamol and Ipratropium bromide, corticosteroids in the form of hydrocortisone based on Gina guideline in addition to distilled water (at the arrival, 0.5-ml distilled water will be taken and this will be repeated every 30 minutes for three times) using a nebulizer. Peak expiratory flow. Timepoint: 0 min, 30 min, 60 min, 90 min. Method of measurement: Peak Flow Meter. Hospitalization duration. Timepoint: final. Method of measurement: questionnaire. Shahid Beheshti University of Medical Sciences Approved 2019-02-04 Ethics committee of National Research Institute of Tuberculosis and Lung Diseases (NRITLD), Shahid B Masih Daneshvari Hospital, DAR ABAD Tehran Tehran Iran (Islamic Republic of)