Determining the effect of azythromycin in the control of refractory asthma patients
Design
This is a parallel randomized controlled clinical trial that will be performed on 112 patients with chronic resistant asthma. Randomization in this research is done using quadri blocks using syntax written in SPSS program. The duration of the study will be 2 months.
Settings and conduct
This study will conduct as a clinical trial study with 112 patients who will refer to Imam Hossain Hospital of Shahroud. Patients must sign an informed consent form before entering the study.
Participants/Inclusion and exclusion criteria
Inclusion criteria: patients with a diagnosis of chronic asthma by spirometric and clinical findings; existence of chronic asthma for at least the last six months; do not take any antibiotics for at least the last one month and conscious consent to participate in research. Exclusion criteria: incidence of any asthma attack during the research period; allergy to azythromycin or intolerance during treatment and existence of infectious and severe respiratory diseases in at least one month.
Intervention groups
For patients in the intervention group, in addition to routine treatments involving the use of inhaled sprays (airway dilators and corticosteroids) and oral prednisolone, azythromycin 250 mg capsules twice daily for the first day and then daily for four days. The next is given and from the second week to the twelfth week, three capsules (one day in between) of the capsule are prescribed and for patients in the control group, only routine treatments involving the use of inhaled sprays (airway dilators and corticosteroids) and oral prednisolone will be prescribed for 12 weeks.
Main outcome variables
Measuring the severity of chronic asthma and Maximum expiratory volume per second (FEV1)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20100102002954N21
Registration date:2020-10-03, 1399/07/12
Registration timing:prospective
Last update:2020-10-03, 1399/07/12
Update count:0
Registration date
2020-10-03, 1399/07/12
Registrant information
Name
Mohammad Bagher Sohrabi
Name of organization / entity
Shahroud University of Medical Ssciences and Health
Country
Iran (Islamic Republic of)
Phone
+98 23 3239 5054
Email address
mb.sohrabi@shmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-10-21, 1399/07/30
Expected recruitment end date
2021-01-18, 1399/10/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effectiveness of azythromycin in the control of refractory asthma in patients with chronic asthma, a randomized clinical trial
Public title
The effect of azythromycin in the control of refractory asthma patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with a diagnosis of chronic asthma by spirometric and clinical findings,
Existence of chronic asthma for at least the last six months,
Do not take any antibiotics for at least the last one month,
Conscious consent to participate in research.
Exclusion criteria:
Incidence of any asthma attack during the research period
Allergy to azythromycin or intolerance during treatment
Existence of infectious and severe respiratory diseases in at least one month
Age
From 15 years old to 70 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
112
Randomization (investigator's opinion)
Randomized
Randomization description
Patients were allocated to intervention and control groups according to random allocation table that illustrated by a statistician. Randomization was done using permuted block randomization method (Block size was 4) using blocked random allocation syntax in SPSS software. For calculation sample size was 112 and number of blocks was 28. Allocation concealment was done using closed opaque envelope.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahroud University of Medical Sciences
Street address
Shahroud University of Medical Sciences; 7 Tir squer, Shahroud
City
Shahroud
Province
Semnan
Postal code
3616647555
Approval date
2019-12-06, 1398/09/15
Ethics committee reference number
IR.SHMU.REC.1398.115
Health conditions studied
1
Description of health condition studied
Severe persistent asthma
ICD-10 code
J45.5
ICD-10 code description
Severe persistent asthma
Primary outcomes
1
Description
Measuring the severity of chronic asthma
Timepoint
Once a month
Method of measurement
ACQ standard questionnaire
2
Description
Maximum expiratory volume per second (FEV1)
Timepoint
Once a month
Method of measurement
Micromedical spirometer
Secondary outcomes
1
Description
Measurement of expiratory nitric oxide ratio
Timepoint
Once a month
Method of measurement
Exhale nitric oxide test with Nobreath device
Intervention groups
1
Description
Intervention group: for patients in the intervention group, in addition to routine treatments involving the use of inhaled sprays (airway dilators and corticosteroids) and oral prednisolone, azythromycin 250 mg capsules twice daily for the first day and then daily for four days. The next is given and from the second week to the twelfth week, three capsules (one day in between) of the capsule are prescribed.
Category
Treatment - Drugs
2
Description
Control group: for patients in the control group, only routine treatments involving the use of inhaled sprays (airway dilators and corticosteroids) and oral prednisolone will be prescribed for 12 weeks.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Hossein Hospital of Shahroud
Full name of responsible person
ِDr. Ali Najafi
Street address
Imam Hossein Hospital., End Imam street., Shahroud , Iran
City
Shahroud
Province
Semnan
Postal code
3616611151
Phone
+98 23 3234 2000
Fax
+98 23 3233 3902
Email
anajafi@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Dr. Mohammad Hasan Emamian
Street address
Vice chancellor for research; Shahroud University medical Sciences ,7th Tir squar, Shahroud
City
Shahroud
Province
Semnan
Postal code
3616647555
Phone
+98 23 3239 4499
Fax
+98 23 3239 4800
Email
pajouhesh@shmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Vice chancellor for research; Shahroud University medical and 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
Shahroud University of Medical Sciences
Full name of responsible person
Afsane Nikravesh
Position
General Practitioner
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Imam Hossein Hospital, End Imam street, Shahroud, Iran.
City
Shahroud
Province
Semnan
Postal code
3616611151
Phone
+98 23 3234 2000
Fax
+98 23 3233 3902
Email
a_nikravesh@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Dr. Ali Najafi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Internal Medicine
Street address
Imam Hossein hospital., End Imam street., Shahroud., Iran
City
Shahroud
Province
Semnan
Postal code
3616611151
Phone
+98 23 3234 2000
Fax
+98 23 3233 3902
Email
anajafi@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Dr.Mohammad Bagher Sohrabi
Position
General Practitioner
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Imam Hossein Hospital, End Imam street, Shahroud, Iran
City
Shahroud
Province
Semnan
Postal code
3616611151
Phone
+98 23 3234 2000
Fax
+98 23 3233 3902
Email
mb.sohrabi@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available