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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Filippo Bernardi, University of Bologna
ClinicalTrials.gov Identifier:
NCT00912171
First received: June 1, 2009
Last updated: February 14, 2013
Last verified: February 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Obstructive Sleep Apnea Syndrome
 Drug: budesonide (Aircort 50 nasal spray)
Drug: montelukast (Singulair)
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Efficacy of Oral Leukotriene in Long Term Therapy of Mild and Moderate Obstructive Sleep Apnea Syndrome (OSAS) in Children

Resource links provided by NLM:

MedlinePlus related topics: Sleep Apnea
U.S. FDA Resources

Further study details as provided by University of Bologna:

Primary Outcome Measures:
  • Nocturnal polysomnography in the first visit compared with Nocturnal polysomnography in the last visit in patient with Montelukast treatment: [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 45
Study Start Date: January 2009
Study Completion Date: June 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Nasal steroid Drug: 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
Other Name: Aircort 50 nasal spray
Active Comparator: Anti-leukotrienes 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
Other Name: Singulair
Active Comparator: Nasal steroid + anti-leukotrienes Drug: 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
Other Name: Aircort 50 nasal spray
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
Other Name: Singulair

Detailed 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.

  Eligibility

Ages Eligible for Study:   2 Years to 10 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00912171

Locations
Italy
Department if Pediatrics, Hospital S. Orsola-Malpighi , University of Bologna
Bologna, Italy, 40138
Sponsors and Collaborators
University of Bologna
Investigators
Principal Investigator: Filippo Bernardi, Professor University of Bologna
  More Information

Publications:

Responsible Party: Filippo Bernardi, Associate Professor, University of Bologna
ClinicalTrials.gov Identifier: NCT00912171     History of Changes
Other Study ID Numbers: 118/2007/O/Sper
Study First Received: June 1, 2009
Last Updated: February 14, 2013
Health Authority: Italy: Ethics Committee

Keywords provided by University of Bologna:
obstructive sleep apnea syndrome
snoring
adenotonsillar hypertrophy
 polysomnography
intranasal steroids
Anti-leukotrienes

Additional relevant MeSH terms:
Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases
Budesonide
Montelukast
Leukotriene Antagonists
 Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Anti-Inflammatory Agents
Hormone Antagonists

ClinicalTrials.gov processed this record on May 16, 2013