Montelukast Effects on Pulmonary Function in Children With Wheezing Aged Less Than 2 Years
Trial Snapshot
- Phase
- Phase 4
- Sponsor
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Lung function test (flow and resistance)
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 6 Months to 24 Months (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Montelukast
the single arm will receive montelukast
Intervention: Montelukast (Drug)
Outcomes
Primary Outcomes
Lung function test (flow and resistance)
Time Frame: 4 weeks
Secondary Outcomes
- Bronchodilator use Dairy symptoms(4 weeks)
Investigators
Boner Attilio
Prof
Universita di Verona