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NCT00299910 Clinical Trial

Inflammatory Response to Anti Inflammatory Therapy in Children With Sleep Disordered Breathing

Sleep Disordered Breathing Clinical Trial

Official title:
Inflammatory Response to Anti Inflammatory Therapy in Children With Sleep Disordered Breathing

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT00299910
Other study ID # sor388505ctil
Secondary ID
Status Recruiting
Phase Phase 4
First received March 6, 2006
Last updated May 20, 2008
Start date March 2005

Study information
Verified date May 2008
Source Soroka University Medical Center
Contact Aviv D Goldbart, MD, MSc
Phone 972-8-6403400
Email avivgold@bgu.ac.il
Is FDA regulated No
Health authority Israel: Ministry of Health
Study type Interventional

Clinical Trial Summary

This study will assess in a double blind placebo controlled fashion the effects of a 12 week course of oral montelukast/placebo on polysomnographic and radiological findings and will characterize the systemic (serum,urine) and local (upper airway collected biological samples) inflammatory response in children (2-10 years of age) with sleep disordered breathing, fittingthe inclusion and exclusion criteria.

Recruitment information / eligibility
Status Recruiting
Enrollment 50
Est. completion date
Est. primary completion date
Accepts healthy volunteers
Gender Both
Age group 2 Years to 10 Years
Eligibility Inclusion Criteria:2-10 years old

1<AHI<8 measured in an overnight PSG

Exclusion Criteria:

Asthma Previous use or allergy to montelukast Use of antibiotics in the previous 3 weeks Use of corticosteroids in the previous 3 months Craniofacial dysmorphism Genetic or metabolic defined illnesses Adenotonsillectomy or adenoidectomy in the past

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Montelukast

Locations
Country Name City State
Israel Pediatric Sleep Center, Soroka University Medical Center Beer-Sheva

Sponsors (1)
Lead Sponsor Collaborator
Soroka University Medical Center

Country where clinical trial is conducted

Israel, 

References & Publications (1)

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

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