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

NCT ID: NCT00299910

Last Updated: 2008-05-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-03-31

Brief Summary

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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

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Conditions

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Sleep Disordered Breathing

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Montelukast

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

\-
Minimum Eligible Age

2 Years

Maximum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Soroka University Medical Center

OTHER

Sponsor Role lead

Principal Investigators

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Asher Tal, MD

Role: PRINCIPAL_INVESTIGATOR

Soroka University Medical Center

Locations

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Pediatric Sleep Center, Soroka University Medical Center

Beersheba, , Israel

Site Status RECRUITING

Countries

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Israel

Central Contacts

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Aviv D Goldbart, MD, MSc

Role: CONTACT

Phone: 972-8-6403400

Email: [email protected]

Facility Contacts

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Aviv D Goldbart, MD, MSc

Role: primary

References

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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.

Reference Type BACKGROUND
PMID: 15879419 (View on PubMed)

Other Identifiers

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sor388505ctil

Identifier Type: -

Identifier Source: org_study_id