32543: Effect of Montelukast Therapy in Obstructive Sleep Apnea(OSA) Children

• Sponsor: University of Chicago (Other)
• Overall Status: Terminated
• CT.gov ID: NCT01027806
• Collaborator: Merck Sharp & Dohme LLC (Industry)
• Enrollment: 64
• Location: 1
• Arms: 2
• Duration (Months): 49
• Patients Per Site Per Month: 1.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Obstructive Sleep Apnea	Drug: Montelukast	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 64 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• Official Title: A Randomized Double Blind Controlled Trial on the Effect of Montelukast Treatment in Children With Obstructive Sleep Apnea Syndrome
• Study Start Date: Jul 1, 2010
• Actual Primary Completion Date: Aug 1, 2014
• Actual Study Completion Date: Aug 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Montelukast	Drug: Montelukast; 1 pill per day for 4 months
Placebo Comparator: Placebo	Drug: Montelukast; 1 pill per day for 4 months

Outcome Measures

Primary Outcome Measures

1. The Percentage of Children Experiencing a Reduction in Apnea-Hypopnea Index (API) From Baseline (Before Treatment) to After Treatment. [16 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 2 Years to 10 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Eligible for inclusion in the study will be symptomatic snoring children >2 years of age and < 10 years of age, who snore and have an apnea hypopnea index (AHI) >2/hrTST (hour total sleep time), and in whom T&A is therefore contemplated. Also among these, we will include children referred for evaluation for snoring who have a history of allergic rhinitis.

Exclusion Criteria:

• Exclusion criteria will include: Hypersensitivity to montelukast, immunodeficiency or immunosuppressant therapy, craniofacial, neuromuscular, syndromic or defined genetic abnormalities, acute upper respiratory tract infection, systemic corticosteroid therapy or antibiotic therapy in the 2 weeks previous to the study, and children who already had adenotonsillectomy. In addition, children chronically receiving oral antihistamine preparations or nasal decongestants will be required to continue using these medications throughout the duration of the study. Patients receiving immunotherapy will continue on the same regimen without escalation of dose and frequency throughout the duration of the study. In addition, patients with severe OSA who in the opinion of their treating physicians require early surgical intervention for their OSA will be excluded from eligibility to the study.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Chicago	Chicago	Illinois	United States	60637

Sponsors and Collaborators

• University of Chicago
• Merck Sharp & Dohme LLC

Investigators

• Principal Investigator: Leila Gozal, MD, University of Chicago

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Chicago
• ClinicalTrials.gov Identifier: NCT01027806
• Other Study ID Numbers: 09-008A
• First Posted: Dec 9, 2009
• Last Update Posted: May 3, 2019
• Last Verified: Apr 1, 2019

• Keywords provided by University of Chicago: Children; Sleep; Obstructive Sleep Apnea
• Additional relevant MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Montelukast

Study Results

Participant Flow

Arm/Group Title	Montelukast	Placebo
Arm/Group Description	Montelukast: 1 pill per day for 16 weeks	Placebo: 1 pill per day for 16 weeks
Period Title: Overall Study
STARTED	32	32
COMPLETED	28	29
NOT COMPLETED	4	3

Baseline Characteristics

Arm/Group Title	Montelukast	Placebo	Total
Arm/Group Description	Montelukast: 1 pill per day for 16 weeks	Placebo: 1 pill per day for 16 weeks	Total of all reporting groups
Overall Participants	28	29	57
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	5.5 (2.5)	5.6 (2.4)	5.6 (2.5)
Sex: Female, Male (Count of Participants)
Female	14 50%	15 51.7%	29 50.9%
Male	14 50%	14 48.3%	28 49.1%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	12 42.9%	12 41.4%	24 42.1%
White	16 57.1%	17 58.6%	33 57.9%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
United States	28 100%	29 100%	57 100%

Outcome Measures

1. Primary Outcome

Title	The Percentage of Children Experiencing a Reduction in Apnea-Hypopnea Index (API) From Baseline (Before Treatment) to After Treatment.
Time Frame	16 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Montelukast	Placebo
Arm/Group Description	Montelukast: 1 pill per day for 16 weeks	Placebo: 1 pill per day for 16 weeks
Measure Participants	28	29
Reduction in AHI	20 71.4%	2 6.9%
No reduction in AHI	8 28.6%	27 93.1%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Montelukast, Placebo
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Fisher Exact
	Comments

Adverse Events

Arm/Group Title	Montelukast		Placebo
Arm/Group Description	Montelukast: 1 pill per day for 16 weeks		Placebo: 1 pill per day for 16 weeks
All Cause Mortality
	Montelukast		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Montelukast		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/28 (0%)		0/29 (0%)
Other (Not Including Serious) Adverse Events
	Montelukast		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/28 (7.1%)		3/29 (10.3%)
General disorders
Headache	1/28 (3.6%)		1/29 (3.4%)
Nausea	1/28 (3.6%)		2/29 (6.9%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.