The aim of study is to compare the effectiveness of Beclomethason Dipropionate (BDP) and Fluticasone Propionate (FP) in 6-17 year old patients with moderate asthma. Fifty patients aged between 6-16 years referred to allergy clinic of Valie Asr hospital between December and September with symptoms of moderate asthma within at least 6 months were selected. Patients with other known causes of wheezing such as cystic fibrosis and heart disorders were excluded from the study. None of the patients had been receiving inhaled corticosteroids prior the study. The patients randomly allocated into two groups. The first group received 250 µg FP twice daily and the second group received 200 µg BDP TDS for 3 months and pulmonary function tests were done at the beginning of study and at monthly intervals. Daily and night symptoms and continuation of drug prescription were assessed monthly. Both ICS were registered trade mark of Cipla Company and prescribed open label. Pulmonary function tests were done by one person who did not know any information about the kind of therapy. The study protocol was approved by the ethic committee of Zanjan University of Medical Science and all patients or their parents gave written informed consent. Comparisons between two groups were made by Mann-Whitney test and chi-Squared test. P value more than 0.05 was accepted as statistically significant. The outcome of study was improvement of daily and night symptoms, PFT results and reduction in rescue medication.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138812042976N2
Registration date:2010-05-02, 1389/02/12
Registration timing:na
Last update:
Update count:0
Registration date
2010-05-02, 1389/02/12
Registrant information
Name
Akefeh Ahmadiafshar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 24 1422 3095
Email address
akefeh45@zums.ac.ir
Recruitment status
Not enough for processing
Funding source
Zanjan University of Medical Science
Expected recruitment start date
2007-12-07, 1386/09/16
Expected recruitment end date
2007-07-07, 1386/04/16
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparison between Beclomethason Dipropionate and Fluticasone Propionate in 6-17 year old patients with moderate asthma
Public title
The comparison between Beclomethason Dipropionate and Fluticasone Propionate in 6-16 year old patients with moderate asthma
Purpose
Treatment
Inclusion/Exclusion criteria
Patients with symptoms of cough and wheezing at night and after exercise and FEV1 between 60-80% were included in the study. Patients with other known causes of wheezing such as cystic fibrosis and heart disorders were excluded from entry into study. None of patients had been receiving inhaled corticosteroids prior the study.
Age
From 6 years old to 16 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
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
Ethic Commity of Zanjan University of Medical Science
Street address
Zanjan University of Medical Science
City
Zanjan
Postal code
45139-56183
Approval date
2007-12-07, 1386/09/16
Ethics committee reference number
11/3-3/4450
Health conditions studied
1
Description of health condition studied
Effects of inhaled corticosteroids (ICS) in moderate asthma
ICD-10 code
J45
ICD-10 code description
Asthma
Primary outcomes
1
Description
Improvement of daily symptoms
Timepoint
weekly
Method of measurement
questionare
2
Description
improvement of night symptoms
Timepoint
monthly
Method of measurement
questionare
3
Description
reduction of rescue medication
Timepoint
monthly
Method of measurement
questionare
Secondary outcomes
1
Description
improvement of PFT
Timepoint
monthly
Method of measurement
spirometeric measurement
Intervention groups
1
Description
6-16 yrs old pations with moderate asthma
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Valie Asr hospital Allergy clinic
Full name of responsible person
Akefeh Ahmadi Afshar
Street address
Gavazang road, Mousavi Hospital
City
Zanjan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zanjan University Of Medical Science
Full name of responsible person
AKEFEH AHMADI AFSHAR
Street address
Gavazng Road, Mousavi Hosp
City
Zanjan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zanjan University Of Medical Science
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Beheshti Hospital
Full name of responsible person
Mogimi Haji Mohsen
Position
Pediatrician
Other areas of specialty/work
Street address
Beheshti Hospital
City
Langrood
Postal code
Phone
+98 24 1413 0000
Fax
Email
moghimim m@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
ZANJAN UNIVERSITY OF MEDICAL SCIENCE
Full name of responsible person
Akefeh Ahmadi Afshar
Position
Assistant prof, Subspecialist of immunology and allergy
Other areas of specialty/work
Street address
GAVASNG ROAD , MOUSAVI HOSP
City
Zanjan
Postal code
45139-56183
Phone
+98 24 1422 3095
Fax
+98 24 1413 1340
Email
akefeh45@zums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Zanjan University of Medical Science
Full name of responsible person
AKefeh Ahmadiafshar
Position
Assistant prof
Other areas of specialty/work
Street address
Gavazang Avenu Valie Asr Hospital
City
Zanjan
Postal code
45139-56183
Phone
+98 24 1422 3095
Fax
Email
akefeh45@zums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)