Montelukast in Children With Wheezing
Primary Purpose
Wheezing
Status
Unknown status
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
Montelukast
Montelukast
Sponsored by
About this trial
This is an interventional treatment trial for Wheezing focused on measuring wheezing, children, montelukast, bronchodilators, lung function, Rint
Eligibility Criteria
Inclusion Criteria:
- Age between 6-24 months
- Patients with recurrent wheezing (at least 2 episodes in the last 6 months)
- Patients with symptoms at enrollment
Exclusion Criteria:
- Chronic respiratory diseases (cystic fibrosis, chronic lung disease) symptoms at visit 1 that require hospital admission
Sites / Locations
- Clinica Pediatrica Universita' di Verona Policlinico GB Rossi
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Montelukast
Arm Description
the single arm will receive montelukast
Outcomes
Primary Outcome Measures
Lung function test (flow and resistance)
Secondary Outcome Measures
Bronchodilator use Dairy symptoms
Full Information
NCT ID
NCT00775697
First Posted
October 17, 2008
Last Updated
June 18, 2013
Sponsor
Universita di Verona
Collaborators
Azienda Ospedaliera Universitaria Policlinico
1. Study Identification
Unique Protocol Identification Number
NCT00775697
Brief Title
Montelukast in Children With Wheezing
Official Title
Montelukast Effects on Pulmonary Function in Children With Wheezing Aged Less Than 2 Years
Study Type
Interventional
2. Study Status
Record Verification Date
June 2013
Overall Recruitment Status
Unknown status
Study Start Date
September 2009 (undefined)
Primary Completion Date
December 2013 (Anticipated)
Study Completion Date
December 2014 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universita di Verona
Collaborators
Azienda Ospedaliera Universitaria Policlinico
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
In this study children with recurrent wheezing (>/= 2 episodes in the last 6 months)and aged less than 2 years will be enrolled as outpatients. They will undergo lung function evaluation by Rint and by assessment of the flow curves at baseline and after 4 weeks of treatment with Montelukast 4 mg/day. Symptom dairies will be filled by parents during the study period.
Detailed Description
Patients aged less than 2 years with recurrent wheezing. At visit 1 patients with symptoms will be enrolled and the study explained. They will return home with bronchodilator therapy.
Within 1 week they will return for visit 2 to start a run-in period with bronchodilators prn and they will fill dairies with symptoms and drug use. Skin prick test will be evaluated at that time.
At visit 3 after 1 week of the run-in period they will start therapy with Montelukast 4 mg for 4 weeks, using bronchodilators prn and filling diaries.
The final visit will be after four weeks with re-evaluation of the lung function
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Wheezing
Keywords
wheezing, children, montelukast, bronchodilators, lung function, Rint
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Montelukast
Arm Type
Experimental
Arm Description
the single arm will receive montelukast
Intervention Type
Drug
Intervention Name(s)
Montelukast
Other Intervention Name(s)
antileukotrienes
Intervention Description
the arm will be treated with Montelukast 4 mg die for 4 weeks
Intervention Type
Drug
Intervention Name(s)
Montelukast
Other Intervention Name(s)
antileukotrienes
Intervention Description
montelukast 4 mg day for 4 weeks
Primary Outcome Measure Information:
Title
Lung function test (flow and resistance)
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Bronchodilator use Dairy symptoms
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
24 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age between 6-24 months
Patients with recurrent wheezing (at least 2 episodes in the last 6 months)
Patients with symptoms at enrollment
Exclusion Criteria:
Chronic respiratory diseases (cystic fibrosis, chronic lung disease) symptoms at visit 1 that require hospital admission
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Attilio L Boner, MD
Organizational Affiliation
Universita di Verona
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinica Pediatrica Universita' di Verona Policlinico GB Rossi
City
Verona
ZIP/Postal Code
37134
Country
Italy
12. IPD Sharing Statement
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Montelukast in Children With Wheezing
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