Inflammatory Response to Anti Inflammatory Therapy in Children With Sleep Disordered Breathing
Overview[ - collapse ][ - ]
| 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 | Sleep Disordered Breathing |
| Intervention | Drug: Montelukast |
| Phase | Phase 4 |
| Sponsor | Soroka University Medical Center |
| Responsible Party | Soroka University Medical Center |
| ClinicalTrials.gov Identifier | NCT00299910 |
| First Received | March 6, 2006 |
| Last Updated | May 20, 2008 |
| Last verified | May 2008 |
Tracking Information[ + expand ][ + ]
| First Received Date | March 6, 2006 |
|---|---|
| Last Updated Date | May 20, 2008 |
| Start Date | March 2005 |
| Estimated Primary Completion Date | Not Provided |
| Current Primary Outcome Measures | Not Provided |
| Current Secondary Outcome Measures | Not Provided |
Descriptive Information[ + expand ][ + ]
| Brief Title | Inflammatory Response to Anti Inflammatory Therapy in Children With Sleep Disordered Breathing |
|---|---|
| Official Title | Inflammatory Response to Anti Inflammatory Therapy in Children With Sleep Disordered Breathing |
| 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. |
| Detailed Description | Not Provided |
| Study Type | Interventional |
| Study Phase | Phase 4 |
| Study Design | Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment |
| Condition | Sleep Disordered Breathing |
| Intervention | Drug: Montelukast |
| Study Arm (s) | Not Provided |
Recruitment Information[ + expand ][ + ]
| Recruitment Status | Recruiting |
|---|---|
| Estimated Enrollment | 50 |
| Estimated Completion Date | Not Provided |
| Estimated Primary Completion Date | Not Provided |
| Eligibility Criteria | Inclusion Criteria:2-10 years old 1 - 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 - |
| Gender | Both |
| Ages | 2 Years |
| Accepts Healthy Volunteers | Not Provided |
| Contacts | Contact: Aviv D Goldbart, MD, MSc 972-8-6403400 avivgold@bgu.ac.il |
| Location Countries | Israel |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT00299910 |
|---|---|
| Other Study ID Numbers | sor388505ctil |
| Has Data Monitoring Committee | Not Provided |
| Information Provided By | Soroka University Medical Center |
| Study Sponsor | Soroka University Medical Center |
| Collaborators | Not Provided |
| Investigators | Principal Investigator: Asher Tal, MD Soroka University Medical Center |
| Verification Date | May 2008 |
Locations[ + expand ][ + ]
| Pediatric Sleep Center, Soroka University Medical Center | Beer-Sheva, Israel Contact: Aviv D Goldbart, MD, MSc | 972-8-6403400 | avivgold@bgu.ac.ilRecruiting |
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