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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified May 2008 by Soroka University Medical Center.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00299910
First Posted: March 7, 2006
Last Update Posted: May 21, 2008
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.
Information provided by:
Soroka University Medical Center
  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
Primary Purpose: Treatment
Official Title: Inflammatory Response to Anti Inflammatory Therapy in Children With Sleep Disordered Breathing

Resource links provided by NLM:


Further study details as provided by Soroka University Medical Center:

Estimated Enrollment: 50
Study Start Date: March 2005
  Eligibility

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

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
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
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00299910     History of Changes
Other Study ID Numbers: sor388505ctil
First Submitted: March 6, 2006
First Posted: March 7, 2006
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