Montelukast in Children With Wheezing
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.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Montelukast Effects on Pulmonary Function in Children With Wheezing Aged Less Than 2 Years|
- Lung function test (flow and resistance) [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
- Bronchodilator use Dairy symptoms [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
|Study Start Date:||September 2009|
|Estimated Study Completion Date:||December 2014|
|Estimated Primary Completion Date:||December 2013 (Final data collection date for primary outcome measure)|
the single arm will receive montelukast
the arm will be treated with Montelukast 4 mg die for 4 weeks
Other Name: antileukotrienesDrug: Montelukast
montelukast 4 mg day for 4 weeks
Other Name: antileukotrienes
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00775697
|Clinica Pediatrica Universita' di Verona Policlinico GB Rossi|
|Verona, Italy, 37134|
|Principal Investigator:||Attilio L Boner, MD||Universita di Verona|