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

• ClinicalTrials.gov Identifier: NCT00912171
• Recruitment Status: Completed
• First Posted: June 3, 2009
• Last Update Posted: February 15, 2013
• Sponsor: University of Bologna
• Information provided by (Responsible Party): Filippo Bernardi, University of Bologna

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.

Condition or disease	Intervention/treatment	Phase
Obstructive Sleep Apnea Syndrome	Drug: budesonide (Aircort 50 nasal spray); Drug: montelukast (Singulair)	Phase 4

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 45 participants
• 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
• Study Start Date: January 2009
• Actual Primary Completion Date: April 2010
• Actual Study Completion Date: June 2010

Arms and Interventions

Arm	Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

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 ]

Eligibility Criteria

• 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

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:

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.

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.

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.

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.

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.

• Responsible Party: Filippo Bernardi, Associate Professor, University of Bologna
• ClinicalTrials.gov Identifier: NCT00912171
• Other Study ID Numbers: 118/2007/O/Sper
• 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:

Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Syndrome; Disease; Pathologic Processes; Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Budesonide; Montelukast; 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; Leukotriene Antagonists; Hormone Antagonists; Cytochrome P-450 CYP1A2 Inducers; Cytochrome P-450 Enzyme Inducers; Molecular Mechanisms of Pharmacological Action