Wheezing Clinical Trial
Official title:
Montelukast Effects on Pulmonary Function in Children With Wheezing Aged Less Than 2 Years
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.
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
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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