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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

Protocol summary

Study aim
The aim of this study is to evaluate the effect of aminophylline on blood gases, respiratory symptoms, and hospitalization outcomes in patients with COPD.
Design
Clinical trial with a control group, with parallel groups, double-blind, randomized, phase 1 on 70 patients.
Settings and conduct
In Isfahan province, patients are randomly assigned to the intervention (aminophylline) and control (standard treatment) groups. Allocation is performed by an independent person from the treatment team. The study is designed as double-blinded, meaning both patients and assessors are unaware of the treatment type. This is achieved using a placebo with a similar appearance and administration method, along with drug coding. All patients will be continuously monitored for blood gases, clinical symptoms, and pulmonary function.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients aged 20-80 with acute COPD exacerbation. Exclusion criteria: Cardiovascular issues, pneumonia, lung malignancy, decreased consciousness, facial/chest deformities, asthma, advanced malignancy.
Intervention groups
Intervention group: Patients receive aminophylline (250 mg loading dose, 30 mg/hour maintenance) per standard protocol. Control group: Patients receive standard COPD treatment without aminophylline. Both groups are monitored for blood gases, symptoms, and lung function.
Main outcome variables
This study examines the effect of aminophylline on pulmonary function (FEV1, FVC) in patients with acute COPD exacerbation. It analyzes potential improvements in the intervention group compared to the control to assess the intervention’s effectiveness.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20241118063763N1
Registration date: 2025-03-30, 1404/01/10
Registration timing: prospective

Last update: 2025-03-30, 1404/01/10
Update count: 0
Registration date
2025-03-30, 1404/01/10
Registrant information
Name
Noora Behzadian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3333 2714
Email address
behzadiannoor@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-07-01, 1404/04/10
Expected recruitment end date
2026-02-20, 1404/12/01
Actual recruitment start date
2025-07-01, 1404/04/10
Actual recruitment end date
2026-02-20, 1404/12/01
Trial completion date
2026-04-09, 1405/01/20
Scientific title
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
Public title
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
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
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.
Exclusion criteria:
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.
Age
From 42 years old to 90 years old
Gender
Both
Phase
1
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
  • Data analyser
  • Data and Safety Monitoring Board
Sample size
Target sample size: 70
Actual sample size reached: 70
Randomization (investigator's opinion)
Randomized
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 (investigator's opinion)
Double blinded
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
Placebo
Not used
Assignment
Parallel
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.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
Second Floor, Building No. 4, Headquarters, University Campus, Hezar Jerib, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
73461-81746
Approval date
2024-11-13, 1403/08/23
Ethics committee reference number
IR.MUI.MED.REC.1403.331

Health conditions studied

1

Description of health condition studied
chronic obstructive pulmonary disease
ICD-10 code
J96.1
ICD-10 code description
Chronic respiratory failure

Primary outcomes

1

Description
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

2

Description
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

3

Description
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

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Aminophylline is administered at a loading dose of 250 mg and a maintenance dose of 30 mg/hour.
Category
Treatment - Drugs

2

Description
Control group: Received standard treatment for an acute COPD attack without aminophylline administration.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
AL Zahra Hospital
Full name of responsible person
Mrs. Dr. Somieh Sadeghi Haddadzwarah
Street address
Plot 70, Phase 3, Ilham Western St., Kianpars, Ahvaz
City
Ahwaz
Province
Khouzestan
Postal code
6155664745
Phone
+98 61 3333 2714
Email
behzadiannoora@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr Gholamreza Asgari
Street address
Building No. 4, Deputy of Research and Technology, Isfahan University of Medical Sciences and Health Services, Hezar Jerib Street.
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 7898
Email
research@mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Noora Behzadian
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Plot 70, Phase 3, Ilham Western St., Kianpars, Ahvaz
City
Ahwaz
Province
Khouzestan
Postal code
6155664745
Phone
+98 61 3333 2714
Email
behzadiannoora@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Noora Behzadian
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Plot 70, Phase 3, Ilham Western St., Kianpars, Ahvaz
City
Ahwaz
Province
Khouzestan
Postal code
6155664745
Phone
098 61 33332714
Email
behzadiannoora@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Noora Behzadian
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Plot 70, Phase 3, Ilham Western St., Kianpars, Ahvaz
City
Ahwaz
Province
Khouzestan
Postal code
6155664745
Phone
+98 61 3333 2714
Email
behzadiannoora@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
We are in the process of selecting a journal for submission.
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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