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IRCT20241118063763N1 IRCT 2025-03-30 Esfahan University of Medical Sciences The effect of prescribing aminophylline on the recovery of patients with acute COPD attack requiring noninvasive mechanical ventilation and investigating its effect on increasing the efficiency of the respiratory system The effect of prescribing aminophylline on the recovery of patients with acute COPD attack requiring noninvasive mechanical ventilation and investigating its effect on increasing the efficiency of the respiratory system 2025-07-01 anticipated 70 Complete https://irct.ir/trial/80236 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: It should be noted that this study has been conducted for the first time in Iran and is unique in its own way, Randomization description: In this study, 70 eligible patients from those who visited Al-Zahra Hospital were randomly selected. For the random allocation of patients into the intervention and control groups, (specify the method, e.g., random number table, randomization software, or other methods such as block randomization or allocation based on odd and even numbers) was used. This process was conducted by an independent individual, separate from the treatment team, to ensure impartiality. After the initial assessments and necessary tests, the required medications were prescribed for each patient according to the study protocol, Blinding description: The patients did not know the type of study and only took the drugs to treat the disease. Also, the researcher and clinical caregivers were unaware of the final outcome. 1 chronic obstructive pulmonary disease. Intervention 1: Intervention group: Aminophylline is administered at a loading dose of 250 mg and a maintenance dose of 30 mg/hour. Intervention 2: Control group: Received standard treatment for an acute COPD attack without aminophylline administration. No - There is not a plan to make this available Justification or reason for not sharing IPD is We are in the process of selecting a journal for submission.
public Noora Behzadian
Plot 70, Phase 3, Ilham Western St., Kianpars, Ahvaz
Ahwaz Iran (Islamic Republic of) 6155664745 +98 61 3333 2714 behzadiannoora@gmail.com Esfahan University of Medical Sciences scientific Noora Behzadian
Plot 70, Phase 3, Ilham Western St., Kianpars, Ahvaz
Ahwaz Iran (Islamic Republic of) 6155664745 098 61 33332714 behzadiannoora@gmail.com Esfahan University of Medical Sciences Iran (Islamic Republic of) Age between 20 and 80 years. Have an acute attack of COPD. Require NIV treatment. No trauma or facial deformity. No severe decreased level of consciousness. No copious pulmonary secretions. No high risk of aspiration. No cardiorespiratory arrest. 42 years 90 years Both No cardiovascular problems (heart failure, ischemia, arrhythmia, unstable hemodynamics resistant to treatment). No allergy to theophylline or aminophylline. No stomach ulcer. No pneumonia diagnosed in the chest X-ray. No lung malignancy. No decreased level of consciousness. No face or chest deformity. No asthma. No advanced malignancy of any type. No neuromuscular diseases or chest disorders. No pneumothorax. Not pregnant or breastfeeding. No persistent and frequent vomiting. Able to tolerate NIV. No history of theophylline use. J96.1 Chronic respiratory failure Treatment - Drugs Treatment - Drugs Intervention group: Aminophylline is administered at a loading dose of 250 mg and a maintenance dose of 30 mg/hour. Control group: Received standard treatment for an acute COPD attack without aminophylline administration. Examination of lung volume in the control and intervention groups. Timepoint: The effect of aminophylline after 3 days in the intervention group. Method of measurement: Examination of lung volumes through spirometry. Examination of blood gases in two intervention and control groups. Timepoint: Investigating the effect of aminophylline on blood gases in the intervention group after 3 days. Method of measurement: Measurement by taking blood from the patient. Examination of shortness of breath in two intervention and control groups. Timepoint: After the injection of the drug up to three days after the injection. Method of measurement: Borg questionnaire. Esfahan University of Medical Sciences Approved 2024-11-13 Ethics committee of Isfahan University of Medical Sciences Second Floor, Building No. 4, Headquarters, University Campus, Hezar Jerib, Isfahan, Iran Isfahan Isfehan Iran (Islamic Republic of)