NCT00775697

Montelukast in Children With Wheezing

Montelukast Effects on Pulmonary Function in Children With Wheezing Aged Less Than 2 Years

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Universita di Verona · Academic / Other
• Sex: All
• Age: 6 Months – 24 Months
• Healthy volunteers: Not accepted

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

Conditions

• Wheezing

Interventions

Type	Name	Description
DRUG	Montelukast	the arm will be treated with Montelukast 4 mg die for 4 weeks
DRUG	Montelukast	montelukast 4 mg day for 4 weeks

Timeline

• Start date: 2009-09-01
• Primary completion: 2013-12-01
• Completion: 2014-12-01
• First posted: 2008-10-20
• Last updated: 2013-06-19

Locations

1 site across 1 country: Italy