Trial Outcomes & Findings for Effect of Montelukast Therapy in Obstructive Sleep Apnea(OSA) Children (NCT NCT01027806)

NCT ID: NCT01027806

Last Updated: 2019-05-03

Results Overview

• Recruitment status: TERMINATED
• Study phase: PHASE4
• Target enrollment: 64 participants
• Primary outcome timeframe: 16 weeks
• Results posted on: 2019-05-03

Participant Flow

Participant milestones

Measure	Montelukast Montelukast: 1 pill per day for 16 weeks	Placebo Placebo: 1 pill per day for 16 weeks
Overall Study STARTED	32	32
Overall Study COMPLETED	28	29
Overall Study NOT COMPLETED	4	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Montelukast n=28 Participants Montelukast: 1 pill per day for 16 weeks	Placebo n=29 Participants Placebo: 1 pill per day for 16 weeks	Total n=57 Participants Total of all reporting groups
Age, Continuous	5.5 years STANDARD_DEVIATION 2.5 • n=5 Participants	5.6 years STANDARD_DEVIATION 2.4 • n=7 Participants	5.6 years STANDARD_DEVIATION 2.5 • n=5 Participants
Sex: Female, Male Female	14 Participants n=5 Participants	15 Participants n=7 Participants	29 Participants n=5 Participants
Sex: Female, Male Male	14 Participants n=5 Participants	14 Participants n=7 Participants	28 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	12 Participants n=5 Participants	12 Participants n=7 Participants	24 Participants n=5 Participants
Race (NIH/OMB) White	16 Participants n=5 Participants	17 Participants n=7 Participants	33 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	28 participants n=5 Participants	29 participants n=7 Participants	57 participants n=5 Participants

PRIMARY outcome

Timeframe: 16 weeks

Outcome measures

Measure	Montelukast n=28 Participants Montelukast: 1 pill per day for 16 weeks	Placebo n=29 Participants Placebo: 1 pill per day for 16 weeks
The Percentage of Children Experiencing a Reduction in Apnea-Hypopnea Index (API) From Baseline (Before Treatment) to After Treatment. Reduction in AHI	20 Participants	2 Participants
The Percentage of Children Experiencing a Reduction in Apnea-Hypopnea Index (API) From Baseline (Before Treatment) to After Treatment. No reduction in AHI	8 Participants	27 Participants

Adverse Events

Montelukast

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Montelukast n=28 participants at risk Montelukast: 1 pill per day for 16 weeks	Placebo n=29 participants at risk Placebo: 1 pill per day for 16 weeks
General disorders Headache	3.6% 1/28	3.4% 1/29
General disorders Nausea	3.6% 1/28	6.9% 2/29

Additional Information

Leila Kheirandish-Gozal, M.D., M.Sc.

School of Medicine, University of Missouri Health

Phone: (573) 884-3229

Email: gozall@health.missouri.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place