The purpose of this study is to investigate the effect of Fluticasone and Montelukast in recurrent wheeze, ie more than three times a year in children under 5 years. The total sample size is 68 children and sampled centers are Tabriz Children's hospital and Golgasht clinic and children will be randomly divided into two groups. For 34 children will be administered Montelukast tablet 5 mg daily till one month after the baseline visit and for 34 children Fluticasone spray 100 mcg 2 puffs twice a day for 1 month and adjust the dose will be done after one month visit. We visit the child every month for 6 months, and outcomes are assessed based on clinical examination, including coughing, wheezing and shortness of breath .This study is designed for a year. Before starting treatment, inclusion and exclusion criteria are assessed by questionnaire and consent form from parents is completed. Inclusion criteria: children under 5 years, with more than 3 times the number of wheezing in clinical studies and no clinical evidence of other predisposing factors. Exclusion criteria: children under 5 years who have evidence of other predisposing factors for wheezing, such as Gastro Esophageal Reflux Disease, Cystic Fibrosis, heart disease, airway disease, congenital anatomical issues.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201309079429N3
Registration date:2013-09-20, 1392/06/29
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-09-20, 1392/06/29
Registrant information
Name
Mahnaz Sadeghi shabesteri
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1336 4650
Email address
sadeghim@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Tabriz University of Medical Sciences
Expected recruitment start date
2012-04-20, 1391/02/01
Expected recruitment end date
2013-04-21, 1392/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Therapeutic effects of Montelukast and Fluticasone in children under 5 years with recurrent wheeze
Public title
Montelukast and Fluticasone effect in wheeze
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: children under 5 years, with more than 3 times the number of wheezing in clinical studies and no clinical evidence of other predisposing factors. Exclusion criteria: children under 5 years who have evidence of other predisposing factors for wheezing, such as Gastro Esophageal Reflux Disease, Cystic Fibrosis, heart disease, airway disease, congenital anatomical issues.
Age
To 5 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
68
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
Research Departement of Tabriz University of Medical Sciences
Street address
Golgasht street
City
Tabriz
Postal code
Approval date
2012-06-25, 1391/04/05
Ethics committee reference number
9182
Health conditions studied
1
Description of health condition studied
asthma
ICD-10 code
J45
ICD-10 code description
J45.0
Primary outcomes
1
Description
wheeze severity
Timepoint
before intervention and every month after intervention till 6 month
Method of measurement
physical examination and listen breath sounds
Secondary outcomes
1
Description
cough severity
Timepoint
before intervention and every month after intervention till 6 month
Method of measurement
physical examination and ask from parents
2
Description
dyspnea severity
Timepoint
before intervention and every month after intervention till 6 month
Method of measurement
physical examination and ask from parents
Intervention groups
1
Description
For 34 children will be administered Montelukast tablet 5 mg daily till one month after the baseline visit
Category
Treatment - Drugs
2
Description
for 34 children Fluticasone spray 100 mcg 2 puffs twice a day for 1 month and adjust the dose will be done after one month visit.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Tabriz Children Hospital
Full name of responsible person
Dr.Mahnaz Sadeghi Shabestari
Street address
Sheshgelan street
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Students Research Comittee of Tabriz University of Medical Sciences
Street address
Golgasht street
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz University of Medical Sciences
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
Medical Faculty
Full name of responsible person
Dr.Mahnaz Sadeghi Shabestari
Position
Immunologist Allergist /Associated Professor
Other areas of specialty/work
Street address
Childrens Hospital، sheshgelan
City
Tabriz
Postal code
Phone
+98 41152622505
Fax
+98 41 1526 2280
Email
sadeghim@tbzmed.ac.irmabbasnazhad@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Medical Faculty
Full name of responsible person
Mahnaz Sadeghi Shabestari
Position
Associated Professor
Other areas of specialty/work
Street address
Childrens Hospital
City
Tabriz
Postal code
Phone
+98 41152622505
Fax
+98 41 1526 2280
Email
drsadeghim2004@yahoo.commabbasnazhad@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Medical Faculty
Full name of responsible person
Mahnaz Sadeghi Shabestari
Position
Associated Professor
Other areas of specialty/work
Street address
Children Hospital, Sheshgelan
City
Tabriz
Postal code
Phone
+98 41152622505
Fax
+98 41 1526 2280
Email
drsadeghim2004@yahoo.commabbasnazhad@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)