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Completed

NCT Number: NCT00912171

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

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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Key information

Conditions

Obstructive Sleep Apnea Syndrome Apnea Dyssomnias Nervous System Diseases Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Sounds Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders Snoring

Age range

2 year–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Department if Pediatrics, Hospital S. Orsola-Malpighi , University of Bologna

Bologna, 40138, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

budesonide (Aircort 50 nasal spray)

Drug

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

Other names: Aircort 50 nasal spray

montelukast (Singulair)

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

Other names: Singulair

Primary outcomes

  1. Nocturnal polysomnography in the first visit compared with Nocturnal polysomnography in the last visit in patient with Montelukast treatment:

    Time frame: 1 year

Secondary outcomes

  1. 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

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

University of Bologna

Other

Registry information

Official study title

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

Acronym: SB-OSAS

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Jun 3, 2009
Registry last updated
Feb 15, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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