studying the effect of azithromycin on airway remodeling in patients with severe refractory asthma
Design
It is a Randomized, singles center, controlled clinical trial with a parallel group design and double blinded outcomes assessment. Randomization was done by Randomizer website ( www.randomizer.org).
Settings and conduct
This study will be done in asthma specialist clinic. After explaining the study for the patients, informed consent will be signed by them if they accept to enter the study. Act Score, severity of dyspnea and coughing, spirometry, FENO (fractional exhaled nitric oxide), lung CT scan and sputum sampling will be done and recorded before and after the treatment. Ct scan measurements will be done by two radiologists who are blinded to the groups and the mean numbers will be used as the final numbers. The sputum will be induced using a jet nebolizer and hyper-tonic saline. It will be kept in -80 degree until use.
Participants/Inclusion and exclusion criteria
Inclusion Criteria:
Patients suffering from severe refractory asthma who could not be controlled by high dose corticosteroids and long acting beta2 agonists or by antileukotrienes with or without tiotropium. The FEV1 must be less than 80 percent.
Exclusion Criteria:
1-Allergic Bronchopulmonary Aspergillosis
2-Drug allergy
3-Pregnancy or Breast milk feeding
4-Interstitial lung disease such as Vasculitis
5- Recent lung infection
6- Gastroesophageal Reflux
Intervention groups
This study consists of three groups of 25 patients. Patients in the first group takes Azithromycin mg, the next one take Prednisolone 5mg , and last group take Placebo each 12 hours. Patients in each group will take the drugs for 8 months.
Main outcome variables
Need for emergency health services, Act score, FENO, FEV1, outer and outer diameter of bronchuse and bronchial wall thickness in CT scan, TGF beta gene expression in sputum
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20091111002695N8
Registration date:2019-05-19, 1398/02/29
Registration timing:prospective
Last update:2019-05-19, 1398/02/29
Update count:0
Registration date
2019-05-19, 1398/02/29
Registrant information
Name
Majid Mirsadraee
Name of organization / entity
Islamic Azad University- Mashhad branch
Country
Iran (Islamic Republic of)
Phone
+98 51 3841 6694
Email address
majidmirsadraee@mshdiau.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-06-05, 1398/03/15
Expected recruitment end date
2019-09-06, 1398/06/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Azithromycin on airways remodeling in patients with severe refractory asthma
Public title
Effect of Azithromycin in refractory asthma
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients suffering from severe refractory asthma who could not be controlled by high dose corticosteroids and long acting beta2 agonists or by antileukotrienes with or without tiotropium.
FEV1 must be less than 80 percent.
Exclusion criteria:
Allergic bronchopulmonary aspergillosis
Drug allergy
Pregnancy or Breast milk feeding
Interstitial lung disease such as Vasculitis
Recent lung infection
Gastroesophageal reflux
Age
From 18 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
75
Randomization (investigator's opinion)
Randomized
Randomization description
The “Block” randomization method was used to make three treatment groups with block size of 25 for each. Unit of randomization is “individual”. Blocks are then randomly chosen to determine the patients’ assignment into the groups (Azithromycin, Prednisolone and Placebu). The tool used for randomization was “www. Randomizer.org” website which uses “Math.random” method within the javaScript programming language to generate its random numbers.
Allocation concealment: coded drug containers of identical appearance prepared by an independent group.
Blinding (investigator's opinion)
Double blinded
Blinding description
All the drugs will be prepared with united shape, color and packages. the only difference is the code on the package. The drugs will be given to our colleague who is present in the clinic everyday and is blinded to the types of the drugs and groups of treatment. Each time the patients refer to our clinic they will receive the same drug based on their randomized code.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Islamic Azad University- Mashhad branch
Street address
Shahin Far Building, sarab alley, Azadi street
City
Mashhad
Province
Razavi Khorasan
Postal code
9178673799
Approval date
2019-05-01, 1398/02/11
Ethics committee reference number
IR.IAU.MSHD.REC.1398.031
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
Bronchial Wall thickness
Timepoint
Before intervention and 8 months after intervention
Before intervention and 8 months after intervention
Method of measurement
Detecting by Polymerase chain reaction (PCR) of the Sputum
Secondary outcomes
1
Description
Expiratory nitric oxide test with NObreath equipment
Timepoint
Before intervention and 8 months after intervention
Method of measurement
Expiratory nitric oxide test with NObreath equipment
2
Description
Forced expiratory volume in one second (FEV1)
Timepoint
Before intervention and 8 months after intervention
Method of measurement
Micro medical spirometer
3
Description
Asthma control
Timepoint
Before intervention and 8 months after intervention
Method of measurement
Asthma Control Test (ACT) score
4
Description
Number of Need for emergency services because of asthma exacerbation
Timepoint
Before intervention and 8 months after intervention
Method of measurement
Recording the date of asthma exacerbation in the Special Card which will be given to the patients.
Intervention groups
1
Description
Intervention group1: Azithromycin 250mg in form of soft gelatin capsule, one each 12 hours, for 8 months. The Active Pharmaceutical Ingredient is provided by Farabi Pharmaceutical company.
Category
Treatment - Drugs
2
Description
Intervention group2: Prednisoline 5mg in form of soft gelatin capsule, one each 12 hours, for 8 months. The Active Pharmaceutical Ingredient is provided by Alborz Bulk Company.
Category
Treatment - Drugs
3
Description
Control group: Placebo in form of soft gelatin capsule containing Lactose, one each 12 hours, for 8 months.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Asthma specialist clinic
Full name of responsible person
Majid Mirsadraei
Street address
No 80, 15th Kosar, Kosar Ave., Vakilabad Blv.
City
Mashhad
Province
Razavi Khorasan
Postal code
9187147578
Phone
+98 51 3870 4347
Email
majidmirsadraee@mshdiau.ac.ir
Web page address
http://drmirsadraee.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Esmaeil Kheirkhah
Street address
Islamic Azad University of Mashhad, Ostad yousefi St., Emamiyeh Blv, Ghasemabad
City
Mashhad
Province
Razavi Khorasan
Postal code
9187147578
Phone
+98 51 3663 7842
Email
research@mshdiau.ac.ir
Web page address
http://vcr.mshdiau.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
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
Islamic Azad University
Full name of responsible person
Majid Mirsadraei
Position
Full professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
No 80, 15th Kosar, Kosar Ave., Vakilabad Blv.
City
Mashhad
Province
Razavi Khorasan
Postal code
9187147578
Phone
+98 51 3870 4347
Email
majidmirsadraee@mshdiau.ac.ir
Web page address
http://drmirsadraee.ir/
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Majid Mirsadraei
Position
Full Professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
No 80, 15th Kosar, Kosar Ave., Vakilabad Blv.
City
Mashhad
Province
Razavi Khorasan
Postal code
9187147578
Phone
+98 51 3870 4347
Email
majidmirsadraee@mshdiau.ac.ir
Web page address
http://drmirsadraee.ir/
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Majid Mirsadraei
Position
Full Professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
No 80, 15th Kosar, Kosar Ave., Vakilabad Blv.
City
Mashhad
Province
Razavi Khorasan
Postal code
9187147578
Phone
+98 51 3870 4347
Email
majidmirsadraee@mshdiau.ac.ir
Web page address
http://drmirsadraee.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
Yes - There is a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Age
Gender
Asthma Duration
Need for Emergency medical services ( before and after treatment)
ACT Score ( before and after treatment)
FEV1 ( before and after treatment)
FENO( before and after treatment)
Bronchial wall thickness in lung CT-scan( before and after treatment)
TGF-beta gene expression ( before and after treatment)
When the data will become available and for how long
One Month after publishing the results.
To whom data/document is available
There will be no limitation for accessing the data.
Under which criteria data/document could be used
There will be no limitation for accessing the data. If someone need to use the data, he/she might ask the corresponding author for permission.
From where data/document is obtainable
Contact the corresponding author.
What processes are involved for a request to access data/document
After contacting the corresponding author via phone or Email, the data will be provided.