NCT00299910

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2005

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

March 6, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 7, 2006

Completed
Last Updated

May 21, 2008

Status Verified

May 1, 2008

First QC Date

March 6, 2006

Last Update Submit

May 20, 2008

Conditions

Sleep Disordered Breathing

Interventions

MontelukastDRUG

Eligibility Criteria

Age2 Years - 10 Years
Sexall
Age GroupsChild (0-17)

You may qualify if:

  • \<AHI\<8 measured in an overnight PSG

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pediatric Sleep Center, Soroka University Medical Center

Beersheba, Israel

RECRUITING

Related Publications (1)

  • 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.

    PMID: 15879419BACKGROUND

MeSH Terms

Conditions

Sleep Apnea Syndromes

Interventions

montelukast

Condition Hierarchy (Ancestors)

ApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Study Officials

  • Asher Tal, MD

    Soroka University Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Aviv D Goldbart, MD, MSc

CONTACT

972-8-6403400avivgold@bgu.ac.il

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 6, 2006

First Posted

March 7, 2006

Study Start

March 1, 2005

Last Updated

May 21, 2008

Record last verified: 2008-05

Locations

IL(1)