Efficacy of Oral Leukotriene in long term therapy of mild and moderate obstructive sleep apnea syndrome (OSAS) in children. - SB-OSAS

Conditions: MedDRA version: 9.1Level: LLTClassification code 10040979Term: Sleep apnoea syndrome
obstructive sleep apnea syndrome

Registration Number: EUCTR2007-006220-35-IT

Lead Sponsor: AZIENDA OSPEDALIERA DI BOLOGNA POLICLINICO S. ORSOLA M. MALPIGHI

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

Children older than 2 and younger than 10 years.
Diagnosis of mild and/or moderate obstructive apneas (RDI 1.3-8) by overnight polysomnographic evaluation with 4 channels EEG
Adenotonsillar hypertrophy II-III-IV
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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 clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: -To evaluate if therapy with leukotriene may be a valid therapeutic approach in children with adenotonsillar hypertrophy and with mild and moderate OSAS.;Secondary Objective: -To evaluate if leukotriene is less, equally or more efficient than nasal steroid.<br>-To evaluate if leukotriene administrated for 24 weeks improves overnight oximetry, polysomnography and quality of daily and nocturnal life at the end of the therapy.<br>-To evaluate if leukotriene as anti-inflammatory of upper airway really reduces the tonsils and adenoids dimensions .;Primary end point(s): not declared

Secondary Outcome Measures