Montelukast in Children With Wheezing
- Registration Number
- NCT00775697
- Lead Sponsor
- Universita di Verona
- 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
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 40
- Age between 6-24 months
- Patients with recurrent wheezing (at least 2 episodes in the last 6 months)
- Patients with symptoms at enrollment
- Chronic respiratory diseases (cystic fibrosis, chronic lung disease) symptoms at visit 1 that require hospital admission
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Montelukast Montelukast the single arm will receive montelukast
- Primary Outcome Measures
Name Time Method Lung function test (flow and resistance) 4 weeks
- Secondary Outcome Measures
Name Time Method Bronchodilator use Dairy symptoms 4 weeks
Trial Locations
- Locations (1)
Clinica Pediatrica Universita' di Verona Policlinico GB Rossi
🇮🇹Verona, Italy