Wheezing
Conditions
Keywords
wheezing, children, montelukast, bronchodilators, lung function, Rint
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
Interventions
DRUGMontelukast
the arm will be treated with Montelukast 4 mg die for 4 weeks
Sponsors
Azienda Ospedaliera Universitaria Policlinico
Universita di Verona
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Months to 24 Months
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Lung function test (flow and resistance) | 4 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Bronchodilator use Dairy symptoms | 4 weeks |
Countries
Italy
Outcome results
None listed