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IRCT20180523039800N1 IRCT 2018-10-30 Tehran University of Medical Sciences Evaluation of the effect of budesonide nebulizer in patients with exacerbated COPD Comparison and evaluation of the effect of budesonide nebulizer with oral systemic steroids on the amount of peak expiratory flow rate (PEFR) change using peak flowmetry of patients with exacerbated chronic obstructive pulmonary disease (COPD) referred to the emergency department; Non-inferiority Double-Blind Randomized Clinical Trial 2018-09-06 anticipated 80 Complete https://irct.ir/trial/33450 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization method: Simple Randomization unit: Individual Stratified randomization is not included Randomization Tool: Random number table Allocation concealment: The product and placebo are delivered to the physician with code numbers. Then the treatments will be prescribed to the patient based on a random number table, Blinding description: In this study, patients, researchers, health care persons including its physician and nurse, and the outcome evaluator are blinded until the end of the study. For this purpose, the patients are divided into an intervention and control group based on the randomization table and the treatment sample or placebo is sent to the physician with a code and the physician performs the treatments according to the product label. 2 Chronic obstructive pulmonary disease. Intervention 1: Intervention group: ُBudesonide nebulizer (inhaled steroid), Jaber ebne Hayyan Co., 0.5 mg, 3 times, every 30 minutes, and single dose oral placebo tablet. Intervention 2: Control group: Oral prednisolone fort (oral systemic steroid), Abu Raihan Co., 50 mg, single dose, and placebo nebulizer, 3 times, every 30 minutes. Yes - There is a plan to make this available What will be shared: All data will be shared after the unidentifiable of the patients When: 6 months after paper publication To whom: Academic researchers Conditions: In term of analysis the data related to study outcomes Where to obtain: tina_mirrajei@yahoo.com How to obtain: The request will be assessed by research committee of Tehran University of Medical Sciences which will be taken around 3 months Comments:
public Tina Mirrajei
Imam Khomeini Hospital, Keshavarz St
Tehran Iran (Islamic Republic of) 1419733141 +98 21 6693 9010 tina_mirrajei@yahoo.com Tehran University of Medical Sciences scientific Elnaz Vahidi
Imam Khomeini Hospital, Keshavarz St
Tehran Iran (Islamic Republic of) 1419733141 +98 21 6693 9010 evahidi62@yahoo.com Tehran University of Medical Sciences Iran (Islamic Republic of) Patients with exacerbated COPD following respiratory infection 15-70 years old Disease severity of moderate to severe based on GOLD scoring 15 years 70 years Both Exacerbated COPD with a cause other than respiratory infection History of asthma, allergic rhinitis or atopy History of systemic corticosteroids more than 1500 micrograms/ day over the past month Patients with decreased consciousness Known psychological disorder and inability to cooperate in the study J44.1 Chronic obstructive pulmonary disease with (acute) exacerbation Treatment - Drugs Treatment - Drugs Intervention group: ُBudesonide nebulizer (inhaled steroid), Jaber ebne Hayyan Co., 0.5 mg, 3 times, every 30 minutes, and single dose oral placebo tablet Control group: Oral prednisolone fort (oral systemic steroid), Abu Raihan Co., 50 mg, single dose, and placebo nebulizer, 3 times, every 30 minutes Variation in peak expiratory flow rate. Timepoint: 30 and 60 minutes, and 3, 6, 12, and 24 hours later. Method of measurement: Peak flow meter device. Variation in FEV1 percentage. Timepoint: 30 and 60 minutes and 3, 6, 12 and 24 hours later. Method of measurement: Spirometry. Tehran University of Medical Sciences Approved 2018-05-05 Ethics committee of Tehran University of Medical Sciences Sixth floor, University central building, Qods St, Keshavarz St. Tehran Tehran Iran (Islamic Republic of)