The effects of AD098, AD153 and AD639 on obstructive sleep apnoea (OSA)

The effects of AD098, AD153 and AD639 on obstructive sleep apnoea (OSA) severity in men and women with moderate-to-severe OSA

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12618001499279

Enrollment

Registered

2018-09-06

Start date

2019-02-04

Completion date

2019-06-25

Last updated

2022-09-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The primary aim of this study is to assess the effect that three combinations of drugs (known as AD098, AD153, AD639) have on sleep apnoea severity (i.e. apnoea/hypopnoea index) compared to placebo. Additional measures of sleep apnoea severity, cardiovascular and sleepiness outcomes will also be assessed as secondary outcomes.

Interventions

Arm 1: AD098 - (single dose [one night], combination of drugs [60mg+5mg], oral capsule, administered prior to sleep) Arm 2: AD153 - (single dose [one night], combination of drugs [50mg+5mg], oral capsule, administered prior to sleep) Arm 3: AD639 - (single dose [one night], single drug [5mg], oral capsule, administered prior to sleep) Approximately 1-week washout between each arm To ensure adherence, all drugs are to be administered by research staff during the in-laboratory sleep studies (poly

Study design

Allocation

Randomised controlled trial

Intervention model

Crossover

Primary purpose

Treatment

Masking

Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

18 Years to 70 Years

Healthy volunteers

Inclusion criteria

Otherwise healthy men and women with moderate-to-severe obstructive sleep apnoea

Exclusion criteria

•Any chronic medical condition other than controlled hypertension, hyperlipidemia, diabetes. •Any medication known to influence breathing, sleep/arousal or muscle physiology. •Claustrophobia. •Inability to sleep supine. •BMI>45 •Central apnea index >5 events/h •Tonsillar hypertrophy or craniofacial malformation •Allergy to lidocaine, oxymetazoline HCl or study medications •For women: Pregnancy or breast feeding.

Outcome results