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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2007-006220-35-IT

Enrollment

Registered

2008-07-02

Start date

2008-06-03

Completion date

Unknown

Last updated

2025-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

obstructive sleep apnea syndrome MedDRA version: 9.1 Level: LLT Classification code 10040979 Term: Sleep apnoea syndrome

Interventions

Trade Name: SINGULAIR*BB 28CPR MAST 5MG Pharmaceutical Form: Chewable tablet INN or Proposed INN: Montelukast Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 5- Tr

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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. -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. -To evaluate if leukotriene as anti-inflammatory of upper airway really reduces the tonsils and adenoids dimensions .;Primary end point(s): not declared	—

Measure

Time frame

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. -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. -To evaluate if leukotriene as anti-inflammatory of upper airway really reduces the tonsils and adenoids dimensions .;Primary end point(s): not declared

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Countries

Italy

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026