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

Primary Purpose

Sleep Disordered Breathing

Status

Unknown status

Phase

Phase 4

Locations

Israel

Study Type

Interventional

Intervention

Montelukast

About this trial

This is an interventional treatment trial for Sleep Disordered Breathing

Eligibility Criteria

2 Years - 10 Years (Child)All Sexes

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 -

Sites / Locations

Pediatric Sleep Center, Soroka University Medical CenterRecruiting

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT00299910

First Posted

March 6, 2006

Last Updated

May 20, 2008

Sponsor

Soroka University Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT00299910

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2008

Overall Recruitment Status

Unknown status

Study Start Date

March 2005 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Soroka University Medical Center

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Sleep Disordered Breathing

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

Double

Allocation

Randomized

Enrollment

50 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Montelukast

10. Eligibility

Sex

All

Minimum Age & Unit of Time

2 Years

Maximum Age & Unit of Time

10 Years

Eligibility Criteria

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Aviv D Goldbart, MD, MSc

Phone

972-8-6403400

avivgold@bgu.ac.il

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Asher Tal, MD

Organizational Affiliation

Soroka University Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Pediatric Sleep Center, Soroka University Medical Center

City

Beer-Sheva

Country

Israel

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Aviv D Goldbart, MD, MSc

Phone

972-8-6403400

avivgold@bgu.ac.il

12. IPD Sharing Statement

Citations:

PubMed Identifier

15879419

Citation

Goldbart AD, Goldman JL, Veling MC, Gozal D. Leukotriene modifier therapy for mild sleep-disordered breathing in children. Am J Respir Crit Care Med. 2005 Aug 1;172(3):364-70. doi: 10.1164/rccm.200408-1064OC. Epub 2005 May 5.

Results Reference

background

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

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