The goal of the study is to prevent asthma thunderstorm. Clinical trials are randomized, control group with placebo and double blind.Inclusion criteria includes persons with the history of TS asthma. Exclusion criteria includes the persons with higher than 60 years and lower than 14 years old; use asthma maintenance drugs at the beginning of study; having asthma symptoms at the beginning of study; having chronic asthma at the start of study; FEV1 less than predicted eighty percent; appearing the asthma symptoms during the study so that patient needs maintenance treatment; symptoms of acute coronary syndrome; pregnant women; disability to do spirometry with high quality; Contraindications to perform spirometry; asking patients to get out of the study. Sample size is 54 persons.This study has intervention with inhaled budesonide. The date of intervention is three months.The primary outcome is to measure FEV1 whose time point measurement is three months after starting intervention and the method of measurement is spirometry. Secondary outcome is to study of asthma exacerbation whose time point measurement is three months after starting intervention and method of measurement is questionnaire.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016102520828N2
Registration date:2017-01-02, 1395/10/13
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-01-02, 1395/10/13
Registrant information
Name
Maryam Haddadzadeh Shoushtari
Name of organization / entity
Ahvaz Jundishapour University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 3292 1839
Email address
haddadzadeh-m@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Deputy for Research of Ahvaz Jundishapur University Of Medical Sciences
Expected recruitment start date
2016-10-06, 1395/07/15
Expected recruitment end date
2017-01-04, 1395/10/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of inhaled corticosteroid in the prevention of thunderstorm asthma
Public title
Prevention of thunderstorm asthma
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria includes persons with the history of TS asthma. Exclusion criteria includes the persons with higher than 60 years and lower than 14 years old; use asthma maintenance drugs at the beginning of study; having asthma symptoms at the beginning of study; having chronic asthma at the start of study; FEV1 less than predicted eighty percent; appearing the asthma symptoms during the study so that patient needs maintenance treatment; symptoms of acute coronary syndrome; pregnant women; disability to do spirometry with high quality; Contraindications to perform spirometry; asking patients to get out of the study.
Age
From 14 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
54
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ahvaz Jundishpur University of Medical Sciences
Street address
Golestan
City
Ahvaz
Postal code
61357-15794
Approval date
2016-11-05, 1395/08/15
Ethics committee reference number
IR.AJUMS.REC.1395.477
Health conditions studied
1
Description of health condition studied
Thunderstorm asthma
ICD-10 code
J45
ICD-10 code description
Asthma
Primary outcomes
1
Description
FEV1
Timepoint
After three months
Method of measurement
spirometry
Secondary outcomes
1
Description
Aasthma exacerbation measurement
Timepoint
After three months
Method of measurement
Fill in standard asthma excerbation questionaire
Intervention groups
1
Description
inhaled budesonide, 400 microgram daily for three months
Category
Treatment - Drugs
2
Description
inhaled placebo,400 microgram daily for three months
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Ahvaz Imam Khomeini Hospital
Full name of responsible person
Saberh Shahhaidari
Street address
Ahvaz Imam khomeini Hospital
City
Ahvaz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Behzad Sharif Makhmalzadeh
Street address
Golestan
City
Ahvaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?