Trial Outcomes & Findings for Montelukast and Inhaled Nasal Steroid Tx in Adult Obstructive Sleep Apnea (OSA) (NCT NCT01089647)

NCT ID: NCT01089647

Last Updated: 2018-12-03

Results Overview

by decreasing nasal congestion, we hope to decrease the number of respiratory events per hour of sleep back to the normal range

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 34 participants
• Primary outcome timeframe: 3 months
• Results posted on: 2018-12-03

Participant Flow

Thirty-four consecutive patients were recruited from the sleep medicine clinic at St. Luke's Health System from 24 June 2010 to 20 March 2013

Participant milestones

Measure	Budesonide and Montelukast treatment arm budesonide and montelukast: budesonide aqua nasal spray 1 spray each nostril bid for 12 weeks Montelukast pill 10 mg po daily for 12 weeks	Placebo sugar pill, salt water nasal spray Placebo: sugar pill po daily for 12 weeks salt water nasal spray 1 spray each nostril bid for 12 weeks
Overall Study STARTED	17	17
Overall Study COMPLETED	13	13
Overall Study NOT COMPLETED	4	4

Reasons for withdrawal

Measure	Budesonide and Montelukast treatment arm budesonide and montelukast: budesonide aqua nasal spray 1 spray each nostril bid for 12 weeks Montelukast pill 10 mg po daily for 12 weeks	Placebo sugar pill, salt water nasal spray Placebo: sugar pill po daily for 12 weeks salt water nasal spray 1 spray each nostril bid for 12 weeks
Overall Study Lost to Follow-up	2	2
Overall Study Withdrawal by Subject	2	1
Overall Study Adverse Event	0	1

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Placebo n=17 Participants sugar pill, salt water nasal spray Placebo: sugar pill po daily for 12 weeks salt water nasal spray 1 spray each nostril bid for 12 weeks	Budesonide and Montelukast n=17 Participants treatment arm budesonide and montelukast: budesonide aqua nasal spray 1 spray each nostril bid for 12 weeks Montelukast pill 10 mg po daily for 12 weeks	Total n=34 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=17 Participants	0 Participants n=17 Participants	0 Participants n=34 Participants
Age, Categorical Between 18 and 65 years	7 Participants n=17 Participants	10 Participants n=17 Participants	17 Participants n=34 Participants
Age, Categorical >=65 years	10 Participants n=17 Participants	7 Participants n=17 Participants	17 Participants n=34 Participants
Sex: Female, Male Female	10 Participants n=17 Participants	4 Participants n=17 Participants	14 Participants n=34 Participants
Sex: Female, Male Male	7 Participants n=17 Participants	13 Participants n=17 Participants	20 Participants n=34 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=17 Participants	0 Participants n=17 Participants	0 Participants n=34 Participants
Race (NIH/OMB) Asian	0 Participants n=17 Participants	0 Participants n=17 Participants	0 Participants n=34 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=17 Participants	0 Participants n=17 Participants	0 Participants n=34 Participants
Race (NIH/OMB) Black or African American	1 Participants n=17 Participants	0 Participants n=17 Participants	1 Participants n=34 Participants
Race (NIH/OMB) White	16 Participants n=17 Participants	14 Participants n=17 Participants	30 Participants n=34 Participants
Race (NIH/OMB) More than one race	0 Participants n=17 Participants	3 Participants n=17 Participants	3 Participants n=34 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=17 Participants	0 Participants n=17 Participants	0 Participants n=34 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	17 participants n=17 Participants	17 participants n=17 Participants	34 participants n=34 Participants

PRIMARY outcome

Timeframe: 3 months

by decreasing nasal congestion, we hope to decrease the number of respiratory events per hour of sleep back to the normal range

Outcome measures

Measure	Budesonide and Montelukast n=13 Participants treatment arm budesonide and montelukast: budesonide aqua nasal spray 1 spray each nostril bid for 12 weeks Montelukast pill 10 mg po daily for 12 weeks	Placebo n=13 Participants sugar pill, salt water nasal spray Placebo: sugar pill po daily for 12 weeks salt water nasal spray 1 spray each nostril bid for 12 weeks
Number of Participants With a Decrease in the Number of Apnea and/or Hypopnea Events to <5 Per Hour of Sleep	5 Participants	3 Participants

Adverse Events

Budesonide and Montelukast

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Budesonide and Montelukast n=13 participants at risk treatment arm budesonide and montelukast: budesonide aqua nasal spray 1 spray each nostril bid for 12 weeks Montelukast pill 10 mg po daily for 12 weeks	Placebo n=13 participants at risk sugar pill, salt water nasal spray Placebo: sugar pill po daily for 12 weeks salt water nasal spray 1 spray each nostril bid for 12 weeks
Respiratory, thoracic and mediastinal disorders nosebleed	15.4% 2/13	7.7% 1/13
Musculoskeletal and connective tissue disorders lower leg swelling	0.00% 0/13	7.7% 1/13

Additional Information

Dr. Ann Romaker

University of Cincinnati

Phone: 513-475-7500

Email: romakean@ucmail.uc.edu

Results disclosure agreements

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