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

Soroka University Medical Center

Status and phase: Unknown; Phase 4

Conditions: Sleep Disordered Breathing

Treatments: Drug: Montelukast

Study type: Interventional

Funder types: Other

Identifiers

NCT00299910

sor388505ctil

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 2 to 10 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind