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

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00299910

Enrollment

Registered

2006-03-07

Start date

2005-03-31

Completion date

Unknown

Last updated

2008-05-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sleep Disordered Breathing

Brief 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.

Interventions

DRUGMontelukast

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

2 Years to 10 Years

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 \-

Countries

Israel

Contacts

Primary ContactAviv D Goldbart, MD, MSc

avivgold@bgu.ac.il972-8-6403400

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026