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

University of Bologna

Status and phase: Completed; Phase 4

Conditions: Obstructive Sleep Apnea Syndrome

Treatments: Drug: montelukast (Singulair); Drug: budesonide (Aircort 50 nasal spray)

Study type: Interventional

Funder types: Other

Identifiers

NCT00912171

118/2007/O/Sper

Details and patient eligibility

About

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.

Full 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.

Enrollment: 45 patients

Sex: All

Ages: 2 to 10 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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45 participants in 3 patient groups

Nasal steroid

Active Comparator group

Treatment:

Drug: budesonide (Aircort 50 nasal spray)

Anti-leukotrienes

Active Comparator group

Treatment:

Drug: montelukast (Singulair)

Nasal steroid + anti-leukotrienes

Active Comparator group

Treatment:

Drug: budesonide (Aircort 50 nasal spray)

Drug: montelukast (Singulair)