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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

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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





Information from the National Library of Medicine

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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

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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

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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
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Contact: Aviv D Goldbart, MD, MSc 972-8-6403400 avivgold@bgu.ac.il

Locations
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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
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Principal Investigator: Asher Tal, MD Soroka University Medical Center
Publications:
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ClinicalTrials.gov Identifier: NCT00299910    
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:
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Respiratory Aspiration
Sleep Apnea Syndromes
Respiration Disorders
Respiratory Tract Diseases
Pathologic Processes
Apnea
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Montelukast
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