A randomized, multicenter trial. Inclusion criteria: Ladies and gentlemen between 15 and 65 years as the definitive diagnosis of asthma is confirmed as mild persistent asthma. Exclusion criteria: A) Having any of the criteria for moderate persistent asthma B) Pregnancy - Breastfeeding C) sensitivity to corticosteroids D) other lung diseases like COPD E) use of systemic corticosteroids in acute asthma attacks during two months before the run in period. Sample size:356 patients. Spirometric parameters, including FEV1 and FVC will be used. To assess patients' quality of life miniAQLQ questioner will be used. Primary efficacy variables includes changes in FEV1 over the course of treatment is compared with the initial spirometry. Secondary efficacy variables include changes in FVC, PEF, asthma attacks and changes in AQLQ total score. Eligible patients randomly will be assigned to receive fluticasone 100 twice daily with spacer via inhalation or ciclesonide 80 once daily with spacer via inhalation.The patients will be educated in order to true spacer use.The patients never receive any other drugs related to asthma except salbutamol as rescue medication
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201201028597N1
Registration date:2012-04-03, 1391/01/15
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-04-03, 1391/01/15
Registrant information
Name
Seyed Mohammad Reza Hashemian
Name of organization / entity
NRITLD
Country
Iran (Islamic Republic of)
Phone
+98 21 2296 7767
Email address
smrhashemian@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Massih Daneshvari Hospital
Expected recruitment start date
2011-11-22, 1390/09/01
Expected recruitment end date
2012-03-19, 1390/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison between ciclesonide and fluticasone in patients with mild persistant asthma asthma
Public title
Ciclesonide comparison with fluticasone in mild persistent asthma
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Ladies and gentlemen between 12 and 75 years as the definitive diagnosis of asthma is confirmed as mild persistent asthma: (Symptoms more than two days per week but less than daily incidence, symptoms at night more than two nights in month but less thatn every night, FEV1 ≥ 80% predicted, FEV1 Variability% 20 -% 30 and the use of B2 agonists short acting more than two days a week but less than daily).
Exclusion criteria: A) Having any of the criteria for moderate persistent asthma B) Pregnancy - Breastfeeding C) sensitivity to corticosteroids D) other lung diseases like COPD E) use of systemic corticosteroids in acute asthma attacks during two months before the run in period
Age
From 15 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
356
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
National ethics committee in medical researches
Street address
Enghelab Ave reasearch and technology branch of ministry of health
City
Tehran
Postal code
Approval date
2011-11-19, 1390/08/28
Ethics committee reference number
49/پ90ک-1
Health conditions studied
1
Description of health condition studied
Asthma
ICD-10 code
J45.9
ICD-10 code description
Asthma, unspecified
Primary outcomes
1
Description
Forced expiratory volume in first second(FEV1)
Timepoint
Before intervention and then 2,4, 8, 16 and 24 weeks after start of intervention
Method of measurement
Spirometry
Secondary outcomes
1
Description
Forced vital capacity(FVC)
Timepoint
Before intervention and at 2, 4, 8, 16 and 24 th week and in any time that the patient was referred due to adverse events.
Method of measurement
Spirometry
2
Description
Number of asthma attacks
Timepoint
Any time it happened
Method of measurement
Recorded by patent himself/herself
3
Description
Total score of mini AQLQ questionare
Timepoint
Before intervention and at 2, 4, 8, 16 and 24 th week and in any time that the patient was referred due to adverse events.
Method of measurement
Questionare will be completed by patients
4
Description
Nasopharyngitis as an adverse event
Timepoint
Before intervention and at 2, 4, 8, 16 and 24 th week and in any time that the patient was referred due to adverse events.
Method of measurement
Physical examination and laboratory investigations if needed
5
Description
Any adverse effect due to drug consumption
Timepoint
Before intervention and at 2, 4, 8,16 and 24 th week and in any time that the patient was referred due to adverse events.
Method of measurement
Physical examination and laboratory investigations if needed
Intervention groups
1
Description
Eligible patients are randomly divided to two groups and the intervention group patients will be assigned to receive ciclesonide 80mg once daily with spacer via inhalation. These patients will be educated in order to true spacer use. The patients never receive any other drugs related to asthma except salbutamol as rescue medication.
Category
Treatment - Drugs
2
Description
Eligible patients are randomly divided to two groups and the control group patients will be assigned to receive fluticasone 100 mg twice daily with spacer via inhalation. These patients will be educated in order to true spacer use. The patients never receive any other drugs related to asthma except salbutamol as rescue medication.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Massih Daneshvari Hospital
Full name of responsible person
Street address
City
Tehran
2
Recruitment center
Name of recruitment center
Shahid Modarres Hospital
Full name of responsible person
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Massih Daneshvari hospital
Full name of responsible person
Dr. Mohammadreza Masjedi
Street address
Daraabad-massih daneshvari hospital
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Massih Daneshvari hospital
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
Person responsible for scientific inquiries
Contact
Name of organization / entity
Massih Daneshvari Hospital
Full name of responsible person
Dr Seied Alireza Mahdaviani
Position
Clinical allergy and immunology fellowship
Other areas of specialty/work
Street address
Daraabd
City
Tehran
Postal code
Phone
+98 21 2610 9930
Fax
Email
arishah65@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Massih Daneshvari Hospital
Full name of responsible person
Dr. Fanak Fahimi
Position
researcher of national research center of tuberculosis and lung diseases
Other areas of specialty/work
Street address
Daaraabd-massih daneshvari hospital
City
tehran
Postal code
1956944413
Phone
+98 21 2208 5855
Fax
+98 21 2208 5855
Email
arvin.najafi@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)