Azathioprine effect on improvement of lung function, asthma severity and exacerbation in severe asthmatic patients, before and after treatment with azathioprine
Design
A controlled, parallel-group, double-blind, randomized, phase 3 clinical trial on 40 patients. The table of random numbers generated by the calculator is used for randomization.
Settings and conduct
Study population: 40 patients with asthma will be entered based on history and spirometry whose symptoms were uncontrolled despite primary treatments; Location of study: Patients will be selected from among the patients referred to the pulmonary clinic of Imam Khomeini Hospital or those referred to the personal office of university professors in Ahvaz; Blinding type: double blinded - patient and researcher; How to blind: All medicines are placed in similar and dark-colored packages, a numerical label is placed on the medicine box. Only the pharmacist is aware of the number assigned to the relevant group. Then, in order from number 1 to 40, the package of drugs is given to the researcher to prescribe to the patients.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients with severe asthma whose symptoms have not improved with usual treatments; Non-inclusion criteria: pregnancy, breastfeeding, advanced liver failure or liver enzymes disorders, advanced renal failure, cytopenia, moderate to severe anemia
Lung volume (forced expiratory volume in 1 second; Forced vital capacity; Forced expiratory flow at 25–75% of the pulmonary volume); Forced expiratory volume in 1 second to Forced vital capacity ratio; Quality of life in asthmatic patients score; The distance covered in the 6-minute walk test
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20231219060463N1
Registration date:2024-01-16, 1402/10/26
Registration timing:prospective
Last update:2024-01-16, 1402/10/26
Update count:0
Registration date
2024-01-16, 1402/10/26
Registrant information
Name
Mostafa Ajaman
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3292 1839
Email address
ajaman.m@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-02-09, 1402/11/20
Expected recruitment end date
2024-08-10, 1403/05/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effectiveness of Azathioprine and placebo on lung volumes, exacerbations and severity of asthma in severe asthmatic patients
Public title
Azathioprine effect in severe asthmatic patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Severe asthmatic patients (FEV1<60) diagnosed by pulmonologist
No improvement in symptoms with usual treatments for asthma including Prednisolone 5mg/day, High dose inhaled corticosteroid, Long acting beta agonist and Long acting muscarinic antagonist
Exclusion criteria:
Advanced liver failure
Advanced renal failure
Pregnancy
Breastfeeding
Cytopenia
Moderate to severe anemia
Known allergy to azathioprine
Concomitant treatment with: Allopurinol, Febuxostat, Adalimumab, Anakinra
Elevated liver enzymes (aminasemia)
Age
From 18 years old to 75 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Using a calculator, random numbers from 1 to 40 are generated, 20 numbers and the first number generated by the calculator are assigned to the intervention group and the next 20 numbers to the control group, then the package of medicines is in the order of number 1 to 40 will be given to the researcher to administer to the patients.
Blinding (investigator's opinion)
Double blinded
Blinding description
The study is double-blind, so that both the researcher and the participant do not know about the type of intervention (drug or placebo). All medicines are placed in similar and dark-colored packages, a numerical label is placed on the medicine box. Only the pharmacist is aware of the number assigned to the relevant group. Then, in order from number 1 to 40, the package of drugs is given to the researcher to prescribe to the patients.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Ahvaz Jundiahapur University of Medical Sciences
Street address
َِAhvaz Jundishapur University of Medical Sciences, Golestan Blvd., Golestan Town
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Approval date
2023-12-18, 1402/09/27
Ethics committee reference number
IR.AJUMS.REC.1402.479
Health conditions studied
1
Description of health condition studied
Asthma
ICD-10 code
J45.5
ICD-10 code description
Severe persistent asthma
Primary outcomes
1
Description
Mean forced expiratory volume in second 1
Timepoint
Before intervention and three months after intervention
Method of measurement
Spirometry
2
Description
Mean Forced Vital Capacity (FVC)
Timepoint
Before intervention and three months after intervention
Method of measurement
Spirometry
3
Description
Mean forced expiratory flow at 25–75% of forced vital capacity
Timepoint
Before intervention and three months after intervention
Method of measurement
Spirometry
4
Description
Mean asthma related questionnaire score
Timepoint
Before intervention and three months after intervention
Method of measurement
Asthma related questionnaire GSK 2002
5
Description
The number of exacerbations
Timepoint
before intervention and three months after intervention
Method of measurement
History taking
6
Description
Distance traveled in the 6-minute walking test
Timepoint
Before intervention and 3 months after intervention
Method of measurement
6-minute walk test
7
Description
Relative frequency of asthma recovery based on the forced expiratory volume in 1 second
Timepoint
At the end of the study
Method of measurement
Spirometer
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Azathioprine, 2mg/kg daily tablets for 3 months، made in Ramopharmin pharmaceutical company
Category
Treatment - Drugs
2
Description
Control group: Palcebo, with the same size and shape as azathioprine Produced in the central laboratory of Jundishapur University Faculty of Pharmacy, Ahvaz
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Lung Clinic; Imam Khomeini Hospital
Full name of responsible person
Zahra Mehraban
Street address
Imam Khomeini Hospital, Azadegan Blvd.
City
Ahvaz
Province
Khouzestan
Postal code
6193673166
Phone
+98 61 3221 5574
Email
himam@ajums.ac.ir
2
Recruitment center
Name of recruitment center
Private office of Dr. Zahra Mehraban
Full name of responsible person
Zahra Mehraban
Street address
6th Floor, Jame Jam Complex, Kianpars
City
Ahvaz
Province
Khouzestan
Postal code
.
Phone
+98 939 731 2266
Email
mehraban.z@ajums.ac.ir
3
Recruitment center
Name of recruitment center
Private office of Dr. Hamid Borsi
Full name of responsible person
Hamid Borsi
Street address
2th Floor, Apadana Complex, Ordibehesht corner of East Esfand St. Kianpars
City
Ahvaz
Province
Khouzestan
Postal code
.
Phone
+98 61 3373 1398
Email
Borsi-h@ajums.ac.ir
4
Recruitment center
Name of recruitment center
Private office of Dr. Mehrdad Dargahi MalAmir
Full name of responsible person
Mehrdad Dargahi MalAmir
Street address
6th Floor, Ariyan medical complex, East Sharhrivar St., Kianpars
City
Ahvaz
Province
Khouzestan
Postal code
.
Phone
+98 61 3333 1880
Email
dargahi-m@ajums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mehrnoush Zaker Kish
Street address
Jundishapur university of medical sciences research and technology development vice-chancellor, Golestan Blvd., Golestan town
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 61 3373 8286
Email
info@ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Mostafa Ajaman
Position
Resident of Internal Medicine
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
Internal Medicine Office, Imam Khomeini Hospital, Azadegan Blvd.
City
Ahvaz
Province
Khouzestan
Postal code
6193673111
Phone
+98 61 3292 1839
Email
ajaman.m@ajums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Zahra Mehraban
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Internal Medicine Office, Imam Khomeini Hospital, Azadegan Blvd.
City
Ahvaz
Province
Khouzestan
Postal code
6193673111
Phone
+98 61 3292 1839
Email
mehraban.z@ajums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mostafa Ajaman
Position
Resident of Internal Medicine
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
Internal Medicine Office, Imam Khomeini Hospital, Azadegan Blvd.
City
Ahvaz
Province
Khouzestan
Postal code
6193673111
Phone
+98 61 3292 1839
Email
ajaman.m@ajums.ac.ir
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 information of patients and paraclinical findings of patients in the form of patient code will be provided to other researchers in an unidentifiable manner.
When the data will become available and for how long
The access period starts 6 months after the results are published
To whom data/document is available
Other researchers who intend to conduct similar studies with a similar theme and topic
Under which criteria data/document could be used
To conduct studies with a similar theme and topic
From where data/document is obtainable
To get information, they can go to the office of the internal department of Imam Khomeini Hospital in Ahvaz, located on Azadegan Blvd.
What processes are involved for a request to access data/document
After submitting a written request for data request to the internal group office in Imam Khomeini Hospital of Ahvaz and validating the request through the group office, the data will be provided to the researcher after about two weeks.