The study population consists of COPD patients with acute exacerbation who are admitted in Alzahra hosptial emergency department in 2019 , 2020 and meet the inclusion criteria. The patients are divided into case and control groups by means of random numbers table. Control group are treated with inhaled short-acting B2 agonist, inhaled short-acting anticholinergic, systemic corticosteroid and NIV. Intervention group are treated with addition of loading and maintenance dose of IV aminophylline to the previously mentioned drugs. Dosage of aminophylline is calculated based on pharmacokinetic formulas individually to achieve serum level of 10 mg/ml. In order to double-bling the sampling, normal saline is used in control group and health care provider has no role in patients outcome assessment. Dyspnea improvement, number of admission days, intubation, ICU admission, aminophylline side effects occurrence and blood gas and spirometry parameters are compared between groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria: patients with AECOPD who are candidate for Noninvasive mechanical ventilation
ٍExclusion criteria: allergy to theophylline or aminophylline; recent use of theophylline; cardiovascular diseases; pneumonia and pneumothorax
Intervention groups
control group: prescription of inhaled fast acting B2-agonist, inhaled fast acting anticholinergic and systemic corticosteroid and NIV
intervention group: prescription of inhaled fast acting B2-agonist, inhaled fast acting anticholinergic and systemic corticosteroid, loading and maintenance dose of IV aminophylline and NIV
Main outcome variables
blood gas parameters; dyspnea score; lung volumes (FEV1, FVC)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200204046374N1
Registration date:2020-04-13, 1399/01/25
Registration timing:registered_while_recruiting
Last update:2020-04-13, 1399/01/25
Update count:0
Registration date
2020-04-13, 1399/01/25
Registrant information
Name
Somayeh Sadeghi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3261 6331
Email address
s.sadeghi@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-11-22, 1398/09/01
Expected recruitment end date
2020-06-19, 1399/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of aminophylline in patients with AECOPD who are candidate for Noninvasive mechanical ventilation
Public title
Effect of aminophylline in patients with AECOPD candidates for non invasive ventilation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
patients with AECOPD who are candidate for Noninvasive mechanical ventilation
no contraindication of NIV
Exclusion criteria:
cardiovascular diseases
allergy to theophylline or aminophylline
gastric ulcer
pnuemonia according to chest x-ray
malignancy
facial or chest deformity
asthma
pregnancy and lactation
pneumothorax
recent use of theophylline
Age
From 20 years old to 80 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Outcome assessor
Sample size
Target sample size:
66
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization is performed by means of random numbers table.
Blinding (investigator's opinion)
Double blinded
Blinding description
In order to blind the patients, instead of aminophyllin, normal saline is prescribed in control group. Furthermore, the investigator of the outcome does not attend the patients room during drugs prescription.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Isfahan medical university Committee for Ethics in Biomedical Research
Street address
Hezar jarib St.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2019-08-04, 1398/05/13
Ethics committee reference number
IR.MUI.MED.REC.1398.237
Health conditions studied
1
Description of health condition studied
acute exacerbation of COPD requiring noninvasive mechanical ventilation
ICD-10 code
J44.1
ICD-10 code description
Chronic obstructive pulmonary disease with acute exacerbation, unspecified
Primary outcomes
1
Description
blood gas parameters
Timepoint
2 hours after initiation of the treatment and then daily
Method of measurement
ABG testing
2
Description
dyspnea score
Timepoint
daily
Method of measurement
Borg scale
3
Description
Lung volumes( FEV1 , FVC)
Timepoint
4-6 hours after initiation of the treatment and then on the third day of admission
Method of measurement
post bronchodilation spirometry
Secondary outcomes
1
Description
aminophylline side effects
Timepoint
daily and every 6 hours
Method of measurement
history and physical examination
2
Description
number of admission days
Timepoint
discharge date
Method of measurement
count of admission days
Intervention groups
1
Description
Control group: prescription of fast acting inhaled B2-agonist, fast acting inhaled anticholinergic and systemic corticosteroid and NIV
Category
Treatment - Drugs
2
Description
Intervention group: prescription of fast acting inhaled B2-agonist, fast acting inhaled anticholinergic and systemic corticosteroid, loading and maintenance dose of IV aminophylline and NIV
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra hospital
Full name of responsible person
Dr. Somayeh Sadeghi
Street address
Soffe Blvd.
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Email
alzahra@mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr. Shaghayegh Haghjoy Monfared
Street address
Hezar jarib St.
City
Isfahan
Province
Isfehan
Postal code
73461-81746
Phone
+98 31 3668 5149
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
Dr. Somayeh Sadeghi
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Soffeh Blvd.
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Email
s.sadeghi117917@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr. Somayeh Sadeghi
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Soffeh Blvd.
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Email
s.sadeghi117917@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr. Mohammadsaeid Khaksar
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
Soffeh Blvd.
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Email
msaeid.khaksar@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Demographic data and the result of statistical analysis of the clinical trial
When the data will become available and for how long
2 year later
To whom data/document is available
Researchers
Under which criteria data/document could be used
after publication of the article
From where data/document is obtainable
sending Email to the researchers
What processes are involved for a request to access data/document