NCT00912171

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: University of Bologna · Academic / Other
• Sex: All
• Age: 2 Years – 10 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The aim of the project is to evaluate whether leukotriene is less, equally or more efficient than nasal steroid in children with adenotonsillar hypertrophy and with mild and moderate OSAS checking if leukotriene administrated for 24 weeks improves overnight oximetry, polysomnography and checking if leukotriene as anti-inflammatory of upper airway really reduces the tonsils and adenoids dimensions.

Conditions

• Obstructive Sleep Apnea Syndrome

Interventions

Type	Name	Description
DRUG	budesonide (Aircort 50 nasal spray)	50 mcg per nostril once daily for cycles of 21 days with a break of 7 days for 6 months
DRUG	montelukast (Singulair)	Daily administration in 4 mg chewable tablet for children younger than 6 years or in 5 mg tablet for children 6 years and older

Timeline

• Start date: 2009-01-01
• Primary completion: 2010-04-01
• Completion: 2010-06-01
• First posted: 2009-06-03
• Last updated: 2013-02-15

Locations

1 site across 1 country: Italy