Inflammatory Response to Anti Inflammatory Therapy in Children With Sleep Disordered Breathing
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ClinicalTrials.gov Identifier: NCT00299910
Verified May 2008 by Soroka University Medical Center. Recruitment status was: Recruiting
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.
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Ages Eligible for Study:
2 Years to 10 Years (Child)
Sexes Eligible for Study:
Inclusion Criteria:2-10 years old
1<AHI<8 measured in an overnight PSG
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