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

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ClinicalTrials.gov Identifier: NCT00299910
Recruitment Status : Unknown
Verified May 2008 by Soroka University Medical Center.
Recruitment status was:  Recruiting
First Posted : March 7, 2006
Last Update Posted : May 21, 2008
Sponsor:
Information provided by:
Soroka University Medical Center

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.

Condition or disease Intervention/treatment Phase
Sleep Disordered Breathing Drug: Montelukast Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Inflammatory Response to Anti Inflammatory Therapy in Children With Sleep Disordered Breathing
Study Start Date : March 2005

Resource links provided by the National Library of Medicine

Drug Information available for: Montelukast
U.S. FDA Resources





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Ages Eligible for Study:   2 Years to 10 Years   (Child)
Sexes Eligible for Study:   All
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications:
ClinicalTrials.gov Identifier: NCT00299910     History of Changes
Other Study ID Numbers: sor388505ctil
First Posted: March 7, 2006    Key Record Dates
Last Update Posted: May 21, 2008
Last Verified: May 2008

Additional relevant MeSH terms:
Respiratory Aspiration
Respiration Disorders
Respiratory Tract Diseases
Pathologic Processes
Montelukast
Anti-Inflammatory Agents
Anti-Asthmatic Agents
Respiratory System Agents
Leukotriene Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP1A2 Inducers
Cytochrome P-450 Enzyme Inducers
Molecular Mechanisms of Pharmacological Action