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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2010-06-30

Brief Summary

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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.

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Detailed Description

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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

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Obstructive Sleep Apnea Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Nasal steroid

Group Type ACTIVE_COMPARATOR

budesonide (Aircort 50 nasal spray)

Intervention Type DRUG

50 mcg per nostril once daily for cycles of 21 days with a break of 7 days for 6 months

Anti-leukotrienes

Group Type ACTIVE_COMPARATOR

montelukast (Singulair)

Intervention Type DRUG

Daily administration in 4 mg chewable tablet for children younger than 6 years or in 5 mg tablet for children 6 years and older

Nasal steroid + anti-leukotrienes

Group Type ACTIVE_COMPARATOR

budesonide (Aircort 50 nasal spray)

Intervention Type DRUG

50 mcg per nostril once daily for cycles of 21 days with a break of 7 days for 6 months

montelukast (Singulair)

Intervention Type DRUG

Daily administration in 4 mg chewable tablet for children younger than 6 years or in 5 mg tablet for children 6 years and older

Interventions

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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

Intervention Type 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

Intervention Type DRUG

Other Intervention Names

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Aircort 50 nasal spray Singulair

Eligibility Criteria

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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

Minimum Eligible Age

2 Years

Maximum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No