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

Obstructive Sleep Apnea Syndrome Clinical Trial

— SB-OSAS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00912171
• Other study ID #: 118/2007/O/Sper
• Status: Completed
• Phase: Phase 4
• First received: June 1, 2009
• Last updated: February 14, 2013
• Start date: January 2009
• Est. completion date: June 2010

Study information

• Verified date: February 2013
• Source: University of Bologna
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: June 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Years to 10 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Apnea
• Obstructive Sleep Apnea Syndrome
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive
• Syndrome

Intervention

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
• 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

Locations

Country	Name	City	State
Italy	Department if Pediatrics, Hospital S. Orsola-Malpighi , University of Bologna	Bologna

Sponsors (1)

Lead Sponsor	Collaborator
University of Bologna

Country where clinical trial is conducted

Italy, 

References & Publications (5)

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. Epub 2005 May 5. — View 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. — View 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. Epub 2007 Mar 30. — View Citation

Gozal D, Kheirandish-Gozal L. Sleep apnea in children--treatment considerations. Paediatr Respir Rev. 2006;7 Suppl 1:S58-61. Epub 2006 Jun 5. Review. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Nocturnal polysomnography in the first visit compared with Nocturnal polysomnography in the last visit in patient with Montelukast treatment:		1 year	Yes
Secondary	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		1 year	Yes