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

The recruitment status of this study is unknown because the information has not been verified recently.

Verified May 2008 by Soroka University Medical Center.
Recruitment status was Recruiting

Sponsor:

Information provided by:

Soroka University Medical Center

ClinicalTrials.gov Identifier:

NCT00299910

First received: March 6, 2006

Last updated: May 20, 2008

Last verified: May 2008

History of Changes

Purpose

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
Sleep Disordered Breathing	Drug: Montelukast	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
Official Title:	Inflammatory Response to Anti Inflammatory Therapy in Children With Sleep Disordered Breathing

Resource links provided by NLM:

Drug Information available for: Montelukast sodium Montelukast

U.S. FDA Resources

Further study details as provided by Soroka University Medical Center:

Estimated Enrollment:	50
Study Start Date:	March 2005

Eligibility

Ages Eligible for Study:	2 Years to 10 Years
Genders Eligible for Study:	Both

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00299910

Contacts

Contact: Aviv D Goldbart, MD, MSc

972-8-6403400

avivgold@bgu.ac.il

Locations

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

Sponsors and Collaborators

Soroka University Medical Center

Investigators

Principal Investigator:

Asher Tal, MD

Soroka University Medical Center

More Information

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.

ClinicalTrials.gov Identifier:	NCT00299910 History of Changes
Other Study ID Numbers:	sor388505ctil
Study First Received:	March 6, 2006
Last Updated:	May 20, 2008
Health Authority:	Israel: Ministry of Health

Additional relevant MeSH terms:

Respiratory Aspiration
Sleep Apnea Syndromes
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Apnea
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases

Anti-Inflammatory Agents
Montelukast
Therapeutic Uses
Pharmacologic Actions
Leukotriene Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents

ClinicalTrials.gov processed this record on May 23, 2013

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