Trial Outcomes & Findings for Atomoxetine and Oxybutynin in Obstructive Sleep Apnea (NCT NCT02908529)

Last Updated: 2019-01-29

Results Overview

Based on previous studies the investigators anticipate that Atomoxetine and Oxybutynin will reduce AHI more effectively in subjects with moderate sleep apnea, mildly obese (BMI\<32), Vpassive \> 50% of Veupnea (ventilation during eupneic ventilatory drive), low muscle compensation (Vactive - Vpassive \<1 L/min)

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

22 participants

Primary outcome timeframe

1 night

Results posted on

2019-01-29

Participant Flow

Participant milestones

Participant milestones
Measure	Placebo First, Ato-Oxy Second Placebo-matching ato-oxy administered 30 mins before normal sleep time on first study night, then a 1-week non-treatment period, then ato-oxy administered 30 mins before normal sleep time on second study night.	Ato-Oxy First, Placebo Second Ato-Oxy administered 30 mins before normal sleep time on first study night, then a 1-week non-treatment period, then placebo administered 30 mins before normal sleep time on second study night.
Overall Study STARTED	10	12
Overall Study COMPLETED	10	10
Overall Study NOT COMPLETED	0	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo First, Ato-Oxy Second Placebo-matching ato-oxy administered 30 mins before normal sleep time on first study night, then a 1-week non-treatment period, then ato-oxy administered 30 mins before normal sleep time on second study night.	Ato-Oxy First, Placebo Second Ato-Oxy administered 30 mins before normal sleep time on first study night, then a 1-week non-treatment period, then placebo administered 30 mins before normal sleep time on second study night.
Overall Study Lost to Follow-up	0	2

Baseline Characteristics

Atomoxetine and Oxybutynin in Obstructive Sleep Apnea

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Analyzed Participants n=20 Participants All participants who were randomized, completed both study nights, and were included in the analysis.
Age, Continuous	53 years n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants
Sex: Female, Male Male	16 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	9 Participants n=5 Participants
Race (NIH/OMB) White	10 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 1 night

Population: 2 participants were not analyzed because they dropped out between the 2 intervention arms

Outcome measures

Outcome measures
Measure	Placebo n=20 Participants Placebo (2 tablets) 30 minutes hours before bedtime	Combination Product of Atomoxetine and Oxybutynin n=20 Participants Combination product of Atomoxetine 80 mg and Oxybutynin 5 mg 30 minutes before sleep
Apnea Hypopnea Index (AHI, Events/Hour of Sleep)	28.5 events/hours of sleep Interval 10.9 to 51.6	7.5 events/hours of sleep Interval 2.4 to 18.6

SECONDARY outcome

Timeframe: 1 night

Population: 4 patients did not accept to perform intramuscular EMG measurement (genioglossus electromyography) 2 patients were not analyzed because they dropped out after the first arm of the study

For genioglossus muscle responsiveness, data will be expressed as change in electromyography of genioglossus (GG EMG) for cmH2O change in esophageal pressure.

Outcome measures

Outcome measures
Measure	Placebo n=16 Participants Placebo (2 tablets) 30 minutes hours before bedtime	Combination Product of Atomoxetine and Oxybutynin n=16 Participants Combination product of Atomoxetine 80 mg and Oxybutynin 5 mg 30 minutes before sleep
Genioglossus Muscle Responsiveness to Increased Ventilatory Drive (Esophageal Pressure Swings)	2.2 %GG/cmH2O Interval 1.1 to 4.7	6.3 %GG/cmH2O Interval 3.0 to 18.3

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Combination Product of Atomoxetine and Oxybutynin

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Placebo n=20 participants at risk Placebo 2 capsules 30 mins before bedtime	Combination Product of Atomoxetine and Oxybutynin n=20 participants at risk Combination product of Atomoxetine 80 mg and Oxybutynin 5 mg 30 mins before sleep
Renal and urinary disorders delayed micturition	0.00% 0/20 • 1 night All randomized participants who received at least one dose of desipramine or placebo.	10.0% 2/20 • Number of events 2 • 1 night All randomized participants who received at least one dose of desipramine or placebo.
Skin and subcutaneous tissue disorders Dry mouth	0.00% 0/20 • 1 night All randomized participants who received at least one dose of desipramine or placebo.	5.0% 1/20 • Number of events 1 • 1 night All randomized participants who received at least one dose of desipramine or placebo.
Nervous system disorders insomnia	15.0% 3/20 • Number of events 3 • 1 night All randomized participants who received at least one dose of desipramine or placebo.	5.0% 1/20 • Number of events 1 • 1 night All randomized participants who received at least one dose of desipramine or placebo.
Nervous system disorders headache	0.00% 0/20 • 1 night All randomized participants who received at least one dose of desipramine or placebo.	5.0% 1/20 • Number of events 1 • 1 night All randomized participants who received at least one dose of desipramine or placebo.

Additional Information

Luigi Taranto Montemurro, MD

Brigham and women's Hospital

Phone: 6177326541

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place