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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
Information provided by:
Soroka University Medical Center Identifier:
First received: March 6, 2006
Last updated: May 20, 2008
Last verified: May 2008
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:

Further study details as provided by Soroka University Medical Center:

Estimated Enrollment: 50
Study Start Date: March 2005

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

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
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Please refer to this study by its identifier: NCT00299910

Contact: Aviv D Goldbart, MD, MSc 972-8-6403400

Pediatric Sleep Center, Soroka University Medical Center Recruiting
Beer-Sheva, Israel
Contact: Aviv D Goldbart, MD, MSc    972-8-6403400   
Sponsors and Collaborators
Soroka University Medical Center
Principal Investigator: Asher Tal, MD Soroka University Medical Center
  More Information

Publications: Identifier: NCT00299910     History of Changes
Other Study ID Numbers: sor388505ctil
Study First Received: March 6, 2006
Last Updated: May 20, 2008

Additional relevant MeSH terms:
Respiratory Aspiration
Respiration Disorders
Respiratory Tract Diseases
Pathologic Processes
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 processed this record on May 23, 2017