drugset / Trial / NCT00912171

Efficacy of Oral Leukotriene in Long Term Therapy of Mild and Moderate Obstructive Sleep Apnea Syndrome in Children

NCT00912171

Phase 4 Completed 45 enrolled University of Bologna
RandomizedParallel-groupOpen-labelTreatment

Summary

The aim of the project is to evaluate whether therapy with leukotriene may be a valid therapeutic approach in children with adenotonsillar hypertrophy and with mild and moderate obstructive sleep apnea syndrome (OSAS) and to evaluate whether leukotriene is less, equally or more efficient than nasal steroid.

Timeline

Start
2009-01
Primary completion
2010-04
Completion
2010-06

Drugs

EvaluationDrugModalityDoseRoute
Comparator Budesonide Small molecule 50 ug Intranasal
Comparator Montelukast Other / unclassified 4 mg Oral
Comparator Montelukast Other / unclassified 5 mg Oral