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

NCT00912171 | Completed Phase 4 DMC

• 1 other identifier: 118/2007/O/Sper
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Obstructive Sleep Apnea Syndrome

Keywords

obstructive sleep apnea syndrome; snoring; adenotonsillar hypertrophy; polysomnography; intranasal steroids; Anti-leukotrienes

Outcome Measures

Primary Outcomes (1)

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

  1 year

Secondary Outcomes (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

  1 year

Study Arms (3)

Nasal steroid

ACTIVE COMPARATOR

Drug: budesonide (Aircort 50 nasal spray)

Anti-leukotrienes

ACTIVE COMPARATOR

Drug: montelukast (Singulair)

Nasal steroid + anti-leukotrienes

ACTIVE COMPARATOR

Drug: budesonide (Aircort 50 nasal spray); Drug: montelukast (Singulair)

Interventions

budesonide (Aircort 50 nasal spray) DRUG

50 mcg per nostril once daily for cycles of 21 days with a break of 7 days for 6 months

Also known as: Aircort 50 nasal spray

Nasal steroid; Nasal steroid + anti-leukotrienes

montelukast (Singulair) DRUG

Daily administration in 4 mg chewable tablet for children younger than 6 years or in 5 mg tablet for children 6 years and older

Also known as: Singulair

Anti-leukotrienes; Nasal steroid + anti-leukotrienes

Eligibility Criteria

• Age: 2 Years - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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°

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Bologna: lead

Study Sites (1)

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

Bologna, 40138, Italy

Location

Related Publications (5)

• 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.

  PMID: 17400731 BACKGROUND

• 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.

  PMID: 16840394 BACKGROUND

• 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.

  PMID: 16798597 BACKGROUND

• 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.

  PMID: 16396849 BACKGROUND

• 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.

  PMID: 15879419 BACKGROUND

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Snoring

Interventions

Budesonide; montelukast

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Respiratory Sounds; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Filippo Bernardi, Professor

  University of Bologna

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 1, 2009
• First Posted: June 3, 2009
• Study Start: January 1, 2009
• Primary Completion: April 1, 2010
• Study Completion: June 1, 2010
• Last Updated: February 15, 2013

Record last verified: 2013-02

Locations

IT (1)