Inflammatory Response to Anti Inflammatory Therapy in Children With Sleep Disordered Breathing - Tabular View

Tracking Information

First Received Date ^ICMJE

March 6, 2006

Last Updated Date

May 20, 2008

Start Date ^ICMJE

March 2005

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00299910 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Inflammatory Response to Anti Inflammatory Therapy in Children With 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.

Detailed Description

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment

Condition ^ICMJE

Sleep Disordered Breathing

Intervention ^ICMJE

Drug: Montelukast

Study Arms / Comparison Groups

Publications *

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.

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

2 Years to 10 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Aviv D Goldbart, MD, MSc

972-8-6403400

avivgold@bgu.ac.il

Location Countries ^ICMJE

Israel

Administrative Information

NCT ID ^ICMJE

NCT00299910

Responsible Party

Study ID Numbers ^ICMJE

sor388505ctil

Study Sponsor ^ICMJE

Soroka University Medical Center

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Asher Tal, MD

Soroka University Medical Center

Information Provided By

Soroka University Medical Center

Verification Date

May 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP