The effects of AD047 and AD282 on obstructive sleep apnoea (OSA)

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12618001181291

Enrollment

Registered

2018-07-17

Start date

2018-08-13

Completion date

2019-01-24

Last updated

2019-07-15

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 goal of this study is to determine the effects of two drug combinations (known as AD047 and AD282) on sleep apnoea severity (the apnoea/hypopnoea index) compared to a placebo (sugar pill). Other measures of sleep apnoea severity, upper airway function, breathing and symptoms will also be assessed as secondary outcomes.

Interventions

Arm 1: AD047 - (single dose [one night], combination therapy [80mg+5mg], oral capsule, immediately prior to sleep, 1-week washout between arms) Arm 2: AD282 - (single dose [one night], combination therapy [80mg+2mg], oral capsule, immediately prior to sleep, 1-week washout between arms) Adherence: medication to be administered by an investigator for these 3 single-night (arms 1 and 2 and placebo) in-lab studies to ensure 100% adherence.

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 No maximum

Healthy volunteers

Inclusion criteria

Otherwise healthy men and women with obstructive sleep apnoea aged 18 years or older.

Exclusion criteria

Exclusion Criteria: • Any chronic medical condition other than well controlled hypertension, hyperlipidemia, diabetes. • Any medication known to influence breathing, sleep/arousal or muscle physiology. • Claustrophobia. • Inability to sleep supine. • Known allergy to study medications • Benign prostatic hyperplasia or urinary retention • Individuals with underlying cardiac disease, such as arrhythmias. • Individuals taking psychiatric medications, such as tricyclic antidepressants, or any of the studied medications for medical care. • History of moderate or severe hepatic or renal impairment. • History of seizures. • For women: Pregnancy.

Outcome results