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

Phase 4

Completed

• Conditions: Obstructive Sleep Apnea Syndrome
• Interventions: Drug: budesonide (Aircort 50 nasal spray); Drug: montelukast (Singulair)

• Registration Number: NCT00912171
• Lead Sponsor: University of Bologna

Brief 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.

Study Timeline

• Study Start: 2009-01
• Study First Submitted: 2009-06-01
• Study First Submitted QC: 2009-06-01
• Study First Posted: 2009-06-03
• Primary Completion: 2010-04
• Study Completion: 2010-06
• Status Verified: 2013-02
• Last Update Submitted: 2013-02-14
• Last Update Posted: 2013-02-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

• Diagnosis of mild (RDI 3- <5) or moderate obstructive apneas (RDI 5-8) by overnight polysomnographic evaluation with 4 channels EEG
• Adenotonsillar hypertrophy Friedman score's II-III-IV°

Exclusion Criteria

• Neuromuscular, gastrointestinal, neurological diseases and syndromes of malformations
• Use of leukotrienes and/or nasal and oral steroids in the 4 weeks preceding the initial sleep study
• Acute upper respiratory tract infections
• Adenotonsillectomy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nasal steroid	budesonide (Aircort 50 nasal spray)	-
Anti-leukotrienes	montelukast (Singulair)	-
Nasal steroid + anti-leukotrienes	budesonide (Aircort 50 nasal spray)	-
Nasal steroid + anti-leukotrienes	montelukast (Singulair)	-

Primary Outcome Measures

Name	Time	Method
Nocturnal polysomnography in the first visit compared with Nocturnal polysomnography in the last visit in patient with Montelukast treatment:	1 year

Secondary Outcome Measures

Name	Time	Method
To evaluate the clinical upper airway patency during the night in the patients with history of allergic rhinitis compared with the patients without history of allergic rhinitis first and after the treatment for OSAS	1 year

Trial Locations

Locations (1)

Department if Pediatrics, Hospital S. Orsola-Malpighi , University of Bologna; 🇮🇹 Bologna, Italy