Trial Outcomes & Findings for The Role of Montelukast in Rhinitis and Sleep (NCT NCT00590772)

Results Overview

Daytime sleepiness was assessed on a scale of 0 (none) to 4 with 4 being severe. To determine improvement of daytime sleepiness with active therapy we used a scale of 0 to 4 with 0 being no improvement and 4 being maximal improvement. To determine improvement of daytime fatigue with active therapy we used a scale of 0 to 4 with 0 being no improvement and 4 being significant improvement. For all three above we used data from the last 3 days were averaged and mean of change for each day.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

31 participants

Primary outcome timeframe

baseline and 2 weeks

Results posted on

2014-10-21

Participant Flow

Patients screened in research laboratory

Patients had a run-in to determine symptoms and only if they had congestion with poor sleep and daytime somnolence were they enrolled

Participant milestones

Participant milestones
Measure	Group 1 subjects were randomized to placebo or active drug and then cross over to opposite; however, the details of the randomization are no longer available.
Overall Study STARTED	31
Overall Study COMPLETED	31
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The Role of Montelukast in Rhinitis and Sleep

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Group 1 n=31 Participants cross over
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	31 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	NA Participants n=5 Participants
Sex: Female, Male Male	NA Participants n=5 Participants
Region of Enrollment United States	31 participants n=5 Participants

PRIMARY outcome

Timeframe: baseline and 2 weeks

Daytime sleepiness was assessed on a scale of 0 (none) to 4 with 4 being severe. To determine improvement of daytime sleepiness with active therapy we used a scale of 0 to 4 with 0 being no improvement and 4 being maximal improvement. To determine improvement of daytime fatigue with active therapy we used a scale of 0 to 4 with 0 being no improvement and 4 being significant improvement. For all three above we used data from the last 3 days were averaged and mean of change for each day.

Outcome measures

Outcome measures
Measure	Montelukast n=31 Participants	Placebo n=31 Participants
Change From Baseline in Fatigue and Daytime Sleepiness at 2 Weeks improved daytime fatigue	0.43 units on a scale Standard Deviation NA data are no longer available	-0.32 units on a scale Standard Deviation NA data are no longer available
Change From Baseline in Fatigue and Daytime Sleepiness at 2 Weeks daytime sleepiness	-0.64 units on a scale Standard Deviation NA data are no longer available	0.13 units on a scale Standard Deviation NA data are no longer available
Change From Baseline in Fatigue and Daytime Sleepiness at 2 Weeks improved daytime sleepiness	0.46 units on a scale Standard Deviation NA data are no longer available	-0.25 units on a scale Standard Deviation NA data are no longer available

Adverse Events

Montelukast

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Timothy Craig

Penn State University

Phone: 717-531-6525

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place