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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:
ClinicalTrials.gov Identifier:
NCT00912171
First Posted: June 3, 2009
Last Update Posted: February 15, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Filippo Bernardi, University of Bologna
  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
Intervention Model: Parallel Assignment
Masking: None (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:


Further study details as provided by Filippo Bernardi, 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 ]

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 ]

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

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Ages Eligible for Study:   2 Years to 10 Years   (Child)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Submitted: June 1, 2009
First Posted: June 3, 2009
Last Update Posted: February 15, 2013
Last Verified: February 2013

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

Additional relevant MeSH terms:
Syndrome
Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Disease
Pathologic Processes
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Budesonide
Montelukast
Leukotriene Antagonists
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Hormone Antagonists
Cytochrome P-450 CYP1A2 Inducers
Cytochrome P-450 Enzyme Inducers