Fluticasone and Montelukast therapy in this study of wheezy children under 5 years. This is randomized clinical trial. Patients referred to the Golgasht clinic or Children hospital clinic were randomly divided into two groups. Inclusion criteria: (no abnormalities underlying anatomic disease؛ family history of allergies and asthma patient ) And exclusion criteria: (anatomical issues such as the children with Gastroesophageal Reflux Disease؛ Cystic fibrosis ؛ underlying medical condition such as cardiovascular problems they are not in the study).68 patients should be monitored every 2-4 weeks for 6 months to 6 months to be seen. Assessed response to treatment is based on clinical history and examination. Outcome is reduction of cough and wheeze and dyspnea .
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201204099429N1
Registration date:2013-09-08, 1392/06/17
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-09-08, 1392/06/17
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 Science"
Expected recruitment start date
2013-08-29, 1392/06/07
Expected recruitment end date
2014-03-27, 1393/01/07
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
" Therapeutic effect of Fluticasone and Montelukast in children younger than 5 years with recurrent wheeze"
Public title
" Effects of Montelukast treatment in asthmatic children under 5 years"
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: (no abnormalities underlying anatomic disease؛ family history of allergies and asthma patient ) And exclusion criteria: (anatomical issues such as the children with Gastroesophageal Reflux Disease؛ Cystic fibrosis ؛ underlying medical condition such as cardiovascular problems they are not in the study).
Age
To 5 years old
Gender
Both
Phase
3
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
"Tabriz University of Medical Science"
Street address
"Tabriz، Golghasht street، Azadi Avenue"
City
Tabriz
Postal code
51666-16471
Approval date
2012-08-25, 1391/06/04
Ethics committee reference number
9182
Health conditions studied
1
Description of health condition studied
"Asthma in children"
ICD-10 code
J40،J47
ICD-10 code description
Asthma
Primary outcomes
1
Description
"Wheeze intensity"
Timepoint
The severity of wheezing diagnosed based on clinical examination and recorded every 2-4 weeks to 6 months after starting treatment with Montelukast 5 mg daily and Fluticasone 100 mcg twice a day, patients are followed up.
Method of measurement
Physical examination
Secondary outcomes
1
Description
"Cough intensity"
Timepoint
The severity of coughing diagnosed based on clinical examination and recorded every 2-4 weeks to 6 months after starting treatment with Montelukast 5 mg daily and Fluticasone 100 mcg twice a day, patients are followed up.
Method of measurement
Physical examination
2
Description
"Dyspnea intensity"
Timepoint
The severity of dyspnea diagnosed based on clinical examination and recorded every 2-4 weeks to 6 months after starting treatment with Montelukast 5 mg daily and Fluticasone 100 mcg twice a day, patients are followed up.
Method of measurement
Physical examination
Intervention groups
1
Description
Intervention: 5 mg montelukast daily
Category
Treatment - Drugs
2
Description
Control: fluticasone 100 mcg spray two puffs twice a day
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
"Children Hospital"
Full name of responsible person
"Dr.Mahnaz Sadeghi Shabestari"
Street address
Sheshgelan street، Tabriz
City
Tabriz
2
Recruitment center
Name of recruitment center
"Gholghasht Clinic"
Full name of responsible person
"Dr.Mahnaz Sadeghi Shabestari"
Street address
Golghasht، Azadi Avenue
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
"Tabriz University of Medical Sciences, Assistance Research"
Full name of responsible person
"Dr.Meshkini"
Street address
Golgasht Avenue, Azadi Avenu، Tabriz
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, Assistance Research"
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
"Tabriz University of Medical Science"
Full name of responsible person
"Maryam Abbasnazhad"
Position
"Intern"
Other areas of specialty/work
Street address
Gholghasht street
City
Tabriz
Postal code
Phone
+98 41 1336 4650
Fax
+98 41 1336 4659
Email
mabbasnazhad@yahoo.com
Web page address
www.tbzmed.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
"Children Hospital"
Full name of responsible person
"Dr.Mahnaz Sadeghi Shabestari"
Position
Associate and Specialty Allergy and Immunology Pediatric
Other areas of specialty/work
Street address
Gholghasht street
City
Tabriz
Postal code
Phone
+98 41 1336 4650
Fax
Email
sadeghim@tbzmed.ac.irdrsadeghim2004@yahoo.com
Web page address
www.tbzmed.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Science"
Full name of responsible person
"Maryam Abbasnazhad"
Position
"Intern"
Other areas of specialty/work
Street address
Golghasht street
City
Tabriz
Postal code
Phone
00
Fax
+98 41 1336 4659
Email
mabbasnazhad@yahoo.com
Web page address
www.tbzmed.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)