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Sponsored by: |
Soroka University Medical Center |
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Information provided by: | Soroka University Medical Center |
ClinicalTrials.gov Identifier: | NCT00299910 |
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.
Condition | Intervention | Phase |
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Sleep Disordered Breathing |
Drug: Montelukast |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment |
Official Title: | Inflammatory Response to Anti Inflammatory Therapy in Children With Sleep Disordered Breathing |
Ages Eligible for Study: | 2 Years to 10 Years |
Genders Eligible for Study: | Both |
Inclusion Criteria:2-10 years old
1<AHI<8 measured in an overnight PSG
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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
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Contact: Aviv D Goldbart, MD, MSc | 972-8-6403400 | avivgold@bgu.ac.il |
Israel | |
Pediatric Sleep Center, Soroka University Medical Center | Recruiting |
Beer-Sheva, Israel | |
Contact: Aviv D Goldbart, MD, MSc 972-8-6403400 avivgold@bgu.ac.il |
Principal Investigator: | Asher Tal, MD | Soroka University Medical Center |
Study ID Numbers: | sor388505ctil |
Study First Received: | March 6, 2006 |
Last Updated: | May 20, 2008 |
ClinicalTrials.gov Identifier: | NCT00299910 |
Health Authority: | Israel: Ministry of Health |
Montelukast Sleep Apnea Syndromes Respiratory Tract Diseases Apnea Respiration Disorders |
Dyssomnias Sleep Disorders Leukotriene Antagonists Sleep Disorders, Intrinsic |
Respiratory System Agents Therapeutic Uses Hormone Antagonists Physiological Effects of Drugs |
Nervous System Diseases Hormones, Hormone Substitutes, and Hormone Antagonists Anti-Asthmatic Agents Pharmacologic Actions |