Back to resultsMontelukast for Acute Bronchiolitis and Postbronchiolitis Viral Induced Wheezing
Primary Purpose
Bronchiolitis, Wheezing, Cough
Status
Completed
Phase
Not Applicable
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Montelukast
Sponsored by
About this trial
This is an interventional treatment trial for Bronchiolitis focused on measuring Bronchiolitis, Postbronchiolitis wheezing, Montelukast
Eligibility Criteria
Inclusion Criteria:
- infant in 3-12 months of age with first episode of wheezing or bronchiolitis
- written informed consent by parents
Exclusion Criteria:
- Previous wheezing episode or confirmed asthma or bronchiolitis
- recent bronchodilator use
- immune deficient
- immunosuppressive drug use
- croup or pneumonia diagnosis
- loss of follow up
Sites / Locations
- Hormozgan University of Medical Sciences (HUMS)
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Control
Montelukast
Arm Description
Control group
4mg Montelukast daily for 2 months
Outcomes
Primary Outcome Measures
Respiratory Distress Severity Score (RDSS)
RDSS is measured by wheezing (0, 1, 2)+ Cough (0, 1, 2)+Retraction (0, 1,2)+Respiratory rate(0,1,2)+ Oxygen saturation(0,1,2) scores
Secondary Outcome Measures
average number of cough daily= as expressed parents during visits
none= No cough, Mild=less than 10 daily, Severe=More than 10 daily
Wheezing severity in the physical examination by physician
None= no wheezing, Mild= mild expiratory, Severe= inspiratory and expiratory
Full Information
NCT ID
NCT01370187
First Posted
June 6, 2011
Last Updated
June 13, 2011
Sponsor
Hormozgan University of Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT01370187
Brief Title
Montelukast for Acute Bronchiolitis and Postbronchiolitis Viral Induced Wheezing
Official Title
Montelukast for Acute Bronchiolitis and Postbronchiolitis Viral Induced Wheezing in Infants 3 to 12 Months of Age in Bandar Abbas Children' Hospital
Study Type
Interventional
2. Study Status
Record Verification Date
June 2010
Overall Recruitment Status
Completed
Study Start Date
July 2010 (undefined)
Primary Completion Date
April 2011 (Actual)
Study Completion Date
June 2011 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Hormozgan University of Medical Sciences
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The aim of the current study is to evaluate the effect of Montelukast in treatment of acute bronchiolitis and postbronchiolitis viral induced wheezing of infants 3 to 12 months of age in Bandar Abbas Children' hospital.
Detailed Description
All the patients will be evaluated at the baseline, during hospitalization (daily) and at 2 months and 6 months after starting the intervention.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bronchiolitis, Wheezing, Cough
Keywords
Bronchiolitis, Postbronchiolitis wheezing, Montelukast
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
146 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
No Intervention
Arm Description
Control group
Arm Title
Montelukast
Arm Type
Experimental
Arm Description
4mg Montelukast daily for 2 months
Intervention Type
Drug
Intervention Name(s)
Montelukast
Intervention Description
Montelukast 4mg daily for 2 months
Primary Outcome Measure Information:
Title
Respiratory Distress Severity Score (RDSS)
Description
RDSS is measured by wheezing (0, 1, 2)+ Cough (0, 1, 2)+Retraction (0, 1,2)+Respiratory rate(0,1,2)+ Oxygen saturation(0,1,2) scores
Time Frame
participants will be followed for the duration of hospital stay, an expected average of 3 days
Secondary Outcome Measure Information:
Title
average number of cough daily= as expressed parents during visits
Description
none= No cough, Mild=less than 10 daily, Severe=More than 10 daily
Time Frame
6 months
Title
Wheezing severity in the physical examination by physician
Description
None= no wheezing, Mild= mild expiratory, Severe= inspiratory and expiratory
Time Frame
6 Months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Months
Maximum Age & Unit of Time
12 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
infant in 3-12 months of age with first episode of wheezing or bronchiolitis
written informed consent by parents
Exclusion Criteria:
Previous wheezing episode or confirmed asthma or bronchiolitis
recent bronchodilator use
immune deficient
immunosuppressive drug use
croup or pneumonia diagnosis
loss of follow up
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ali Asghar Parhiz, Resident
Organizational Affiliation
Hormzgan University of Medical Sciences (HUMS)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hormozgan University of Medical Sciences (HUMS)
City
Bandar Abbas
State/Province
Hormozgan
ZIP/Postal Code
79145-3388
Country
Iran, Islamic Republic of
12. IPD Sharing Statement
Learn more about this trial
Montelukast for Acute Bronchiolitis and Postbronchiolitis Viral Induced Wheezing
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