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

Primary Purpose

Obstructive Sleep Apnea Syndrome

Status
Completed
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
budesonide (Aircort 50 nasal spray)
montelukast (Singulair)
Sponsored by
University of Bologna
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obstructive Sleep Apnea Syndrome focused on measuring obstructive sleep apnea syndrome, snoring, adenotonsillar hypertrophy, polysomnography, intranasal steroids, Anti-leukotrienes

Eligibility Criteria

2 Years - 10 Years (Child)All SexesDoes not accept 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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Nasal steroid

Anti-leukotrienes

Nasal steroid + anti-leukotrienes

Arm Description

Outcomes

Primary Outcome Measures

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

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

Full Information

First Posted
June 1, 2009
Last Updated
February 14, 2013
Sponsor
University of Bologna
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1. Study Identification

Unique Protocol Identification Number
NCT00912171
Brief Title
Efficacy of Oral Leukotriene in Long Term Therapy of Mild and Moderate Obstructive Sleep Apnea Syndrome in Children
Acronym
SB-OSAS
Official Title
Efficacy of Oral Leukotriene in Long Term Therapy of Mild and Moderate Obstructive Sleep Apnea Syndrome (OSAS) in Children
Study Type
Interventional

2. Study Status

Record Verification Date
February 2013
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
April 2010 (Actual)
Study Completion Date
June 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Bologna

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea Syndrome
Keywords
obstructive sleep apnea syndrome, snoring, adenotonsillar hypertrophy, polysomnography, intranasal steroids, Anti-leukotrienes

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
45 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Nasal steroid
Arm Type
Active Comparator
Arm Title
Anti-leukotrienes
Arm Type
Active Comparator
Arm Title
Nasal steroid + anti-leukotrienes
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
budesonide (Aircort 50 nasal spray)
Other Intervention Name(s)
Aircort 50 nasal spray
Intervention Description
50 mcg per nostril once daily for cycles of 21 days with a break of 7 days for 6 months
Intervention Type
Drug
Intervention Name(s)
montelukast (Singulair)
Other Intervention Name(s)
Singulair
Intervention Description
Daily administration in 4 mg chewable tablet for children younger than 6 years or in 5 mg tablet for children 6 years and older
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Filippo Bernardi, Professor
Organizational Affiliation
University of Bologna
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department if Pediatrics, Hospital S. Orsola-Malpighi , University of Bologna
City
Bologna
ZIP/Postal Code
40138
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
17400731
Citation
Gozal D, Crabtree VM, Sans Capdevila O, Witcher LA, Kheirandish-Gozal L. C-reactive protein, obstructive sleep apnea, and cognitive dysfunction in school-aged children. Am J Respir Crit Care Med. 2007 Jul 15;176(2):188-93. doi: 10.1164/rccm.200610-1519OC. Epub 2007 Mar 30.
Results Reference
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PubMed Identifier
16840394
Citation
Goldbart AD, Krishna J, Li RC, Serpero LD, Gozal D. Inflammatory mediators in exhaled breath condensate of children with obstructive sleep apnea syndrome. Chest. 2006 Jul;130(1):143-8. doi: 10.1378/chest.130.1.143.
Results Reference
background
PubMed Identifier
16798597
Citation
Gozal D, Kheirandish-Gozal L. Sleep apnea in children--treatment considerations. Paediatr Respir Rev. 2006;7 Suppl 1:S58-61. doi: 10.1016/j.prrv.2006.04.174. Epub 2006 Jun 5.
Results Reference
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PubMed Identifier
16396849
Citation
Kheirandish L, Goldbart AD, Gozal D. Intranasal steroids and oral leukotriene modifier therapy in residual sleep-disordered breathing after tonsillectomy and adenoidectomy in children. Pediatrics. 2006 Jan;117(1):e61-6. doi: 10.1542/peds.2005-0795.
Results Reference
background
PubMed Identifier
15879419
Citation
Goldbart AD, Goldman JL, Veling MC, Gozal D. Leukotriene modifier therapy for mild sleep-disordered breathing in children. Am J Respir Crit Care Med. 2005 Aug 1;172(3):364-70. doi: 10.1164/rccm.200408-1064OC. Epub 2005 May 5.
Results Reference
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Efficacy of Oral Leukotriene in Long Term Therapy of Mild and Moderate Obstructive Sleep Apnea Syndrome in Children

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