NCT01027806

Brief Summary

The investigators leading hypotheses are:

  • Oral therapy with montelukast may lead to improved sleep study findings in children with mild to moderate Obstructive Sleep Apnea Syndrome (OSAS) who require surgical removal of adenoids and tonsils for OSAS.
  • A significant proportion of the children with OSAS treated with montelukast will show reduced severity of OSAS, and this will remove the need for surgical intervention.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
64

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jul 2010

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
terminated

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

First Submitted

Initial submission to the registry

December 7, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 9, 2009

Completed
7 months until next milestone

Study Start

First participant enrolled

July 1, 2010

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
4.8 years until next milestone

Results Posted

Study results publicly available

May 3, 2019

Completed
Last Updated

May 3, 2019

Status Verified

April 1, 2019

Enrollment Period

4.1 years

First QC Date

December 7, 2009

Results QC Date

April 11, 2019

Last Update Submit

April 11, 2019

Conditions

Obstructive Sleep Apnea

Keywords

ChildrenSleepObstructive Sleep Apnea

Outcome Measures

Primary Outcomes (1)

  • The Percentage of Children Experiencing a Reduction in Apnea-Hypopnea Index (API) From Baseline (Before Treatment) to After Treatment.

    16 weeks

Study Arms (2)

Montelukast

ACTIVE COMPARATOR
Drug: Montelukast

Placebo

PLACEBO COMPARATOR
Drug: Montelukast

Interventions

MontelukastDRUG

1 pill per day for 4 months

MontelukastPlacebo

Eligibility Criteria

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Chicago

Chicago, Illinois, 60637, United States

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Interventions

montelukast

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Results Point of Contact

Title
Leila Kheirandish-Gozal, M.D., M.Sc.
Organization
School of Medicine, University of Missouri Health
gozall@health.missouri.edu
(573) 884-3229

Study Officials

  • Leila Gozal, MD

    University of Chicago

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 7, 2009

First Posted

December 9, 2009

Study Start

July 1, 2010

Primary Completion

August 1, 2014

Study Completion

August 1, 2014

Last Updated

May 3, 2019

Results First Posted

May 3, 2019

Record last verified: 2019-04

Locations

US(1)