Sleep Apnea, ObstructivePhase 2KOALANCT04236440

Study on the Safety of Drug BAY2586116 and How it Works in Patients With Obstructive Sleep Apnea (a Sleep Disorder Caused by the Narrowing and Collapse of the Airway During Sleep) Including the Blood Level of the Drug and Effect of Its Doses and Routes of Administration

A Phase 2 study testing BAY2586116 (A1), BAY2586116 (B1) and BAY2586116 (B2) in people with Sleep Apnea, Obstructive, run by Bayer at 1 site in Australia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Sleep Apnea, Obstructive
What is being tested?: BAY2586116 (A1), BAY2586116 (B1) and BAY2586116 (B2)
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 14 participants
Where: 1 siteAustralia
Study dates: 4 Feb 2020to 24 Jun 2021
Phase: Phase 2
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Participant must be 18 years of age or above at the time of signing the informed consent.
Participants need to be diagnosed with OSA but should be considered otherwise healthy at the discretion of the investigator.
Participants do not need to be on CPAP therapy at the time of the study. However, if they are on therapy, participants must commit to keep their treatment schedule constant during the study period, especially the night before each administration of study intervention. For participants on CPAP, this will be monitored objectively using the compliance chip within the CPAP devices.
Female of non-child bearing potential or male.
Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
Female participants:

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-- i. Participants of non-childbearing potential, i.e. post-menopausal (no menses for at least 1 year) or surgically sterile (documented history of tubal ligation, hysterectomy or bilateral oophorectomy).
Male participants:
i. Male participants of reproductive potential must agree to utilize two reliable and acceptable methods of contraception simultaneously when sexually active. This applies for the time period between admission to the study site until 12 weeks after the last administration of the study intervention.
Acceptable methods of contraception include, but are not limited to, (i) condoms (male or female) with or without a spermicidal agent; (ii) diaphragm or cervical cap with spermicide; (iii) intra-uterine device; (iv) hormone-based contraception.
Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
Ability to understand and follow study-related instructions.
The informed consent must be signed before any study specific tests or procedures are done. For Part C reconsent must be signed.

Who cannot join

Severely impaired breathing within two days prior to randomization (e.g. acute nasal congestion during upper airway infection).
Subject with known allergies or hypersensitivities to the study drugs (active substances or excipients of the preparations).
Any other condition which at the discretion of the investigator would make the participant unsuitable for participation in the study and will not allow participation for the full planned study period (e.g. active malignancy or other condition limiting life expectancy to less than 12 months).
Use of any topical medication containing local anesthetics for nose and throat within 2 days before each administration of study intervention.
Donation of more than 100 mL of plasma or equivalent volume of blood within 4 weeks or 500 mL whole blood within 3 months before study drug administration.
Previous participation in this study.

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Participation in another clinical study with study intervention(s) within 90 days prior to first administration.
Heavy smoking, i.e. more than 20 cigarettes per day.
Light smokers who are unable to cease smoking for the duration of the inhouse phases of the study (i.e. Study day 1 in treatment periods 1, 2, 3 and 4).
Drug or alcohol abuse.

Trial locations and contacts

1 site in 1 country.

Australia1 site

Adelaide Institute for Sleep Health
Bedford Park, South Australia, 5042

Other trials in Australia

About this study

Official title: Proof-of-mechanism Single-center, Randomized, Double-blind, Placebo-controlled 2-way Crossover Study to Investigate Pharmacodynamics, Safety, Tolerability and Exposure of BAY 2586116 (Part A) and an Open-label Comparison of Different Application Modes for Single Nasal/Pharyngeal Dose Administrations (Part B and Part C) in 12 Participants With Obstructive Sleep Apnea

The researchers in this study want to learn how drug BAY2586116 works in patients with obstructive sleep apnea (OSA). OSA is a sleep disorder marked by breathing pauses during sleep due to repetitive obstructions of the upper airway. BAY2586116 is a new drug under development for the treatment of OSA. It blocks protein channels expressed on the surface of the upper airways in small mechanoreceptors (a type of molecule that sense and pass stimulus outside a cell on to the inside of the cell through mechanical gate on the surface of the cell). Thus, the negative pressure reflex alerting the brain of inspiration is triggered more easily leading to a stronger activation of throat muscles. This prevents narrowing or collapse of the upper airways during sleep which is one of the pathological key factors in OSA.

Researchers will study the effects of different routes of administration (drops into the nose, spray into the nose or throat or spray into the throat by endoscopy). Endoscopy allows the doctor to look at areas in the throat that cannot be seen with a mirror: a thin tube-like instrument is inserted through the nose to check and give the medication. Different doses of the test drug will be given.

They also want to find out if participants experience any medical problems during the study.

Patients participating in this study will undergo three study parts. After completing Part A and Part B, participants will be asked to join Part C. In Part A, participants will receive both the test drug and placebo (a placebo looks like the test drug but does not have any medicine in it); in Part B, participants will receive the test drug twice via different routes of administration (drops in nose and spray in nose or throat) and in Part C, the participants would receive the test drug once via spray in throat by endoscopy. The sleep of the participants will be monitored by medical equipment. Participants will be asked to visit the clinic 7 times in 14 weeks in total.

Conditions: Sleep Apnea, Obstructive
Being tested: BAY2586116 (A1), Placebo (A2), BAY2586116 (B1), BAY2586116 (B2), BAY2586116 (B3)
Medical subject headings: Sleep Apnea, Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

BAY2586116 (A1)Drug
160 μg BAY2586116 (nasal spray administration)
Placebo (A2)Drug
Placebo matching BAY2586116 (nasal spray administration)
BAY2586116 (B1)Drug
160 μg BAY2586116 (nasal drops)
BAY2586116 (B2)Drug
80 μg BAY2586116 (nasal spray)
BAY2586116 (B3)Drug
160 μg BAY2586116 (pharyngeal spray with direct endoscopic application via a nostril)
BAY2586116 (C)Drug
160 μg BAY2586116 (pharyngeal spray with direct endoscopic application via a nostril). It is the same procedure as described under part B3.

Study groups in NCT04236440
Study group	Role	What they receive
Part A: A1A2+Part B+Part C	Experimental	Part A: Participants will receive a single dose administration of BAY2586116 (A1) in treatment period 1, and a single dose administration of placebo (A2) in treatment period 2. Part B: After successfully completing Part A, participants will proceed to Part B of the study. Participants will receive a single dose administration of BAY2586116 (B1) in treatment period 3. Based on the result of the interim analysis there are two possible scenarios regarding mode of application and doses of BAY2586116 to be administered in treatment period 4: 1) a single dose administration of BAY2586116 (B2) Or 2) a single dose administration of BAY2586116 (B3). Part C: Participants completing Part B will be invited to participate in an additional treatment period with a single dose BAY2586116 (C). Receives: Drug: BAY2586116 (A1); Drug: Placebo (A2); Drug: BAY2586116 (B1); Drug: BAY2586116 (B2); Drug: BAY2586116 (B3); Drug: BAY2586116 (C)
Part A: A2A1+Part B+Part C	Experimental	Part A: Participants will receive a single dose administration of placebo (A2) in treatment period 1, and a single dose administration of BAY2586116 (A1) in treatment period 2. Part B: After successfully completing Part A, participants will proceed to Part B of the study. Participants will receive a single dose administration of BAY2586116 (B1) in treatment period 3. Based on the result of the interim analysis there are two possible scenarios regarding mode of application and doses of BAY2586116 to be administered in treatment period 4: 1) a single dose administration of BAY2586116 (B2) Or 2) a single dose administration of BAY2586116 (B3). Part C: Participants completing Part B will be invited to participate in an additional treatment period with a single dose BAY2586116 (C). Receives: Drug: BAY2586116 (A1); Drug: Placebo (A2); Drug: BAY2586116 (B1); Drug: BAY2586116 (B2); Drug: BAY2586116 (B3); Drug: BAY2586116 (C)

What is being measured

The primary outcome is the main question the study is designed to answer.

Critical closing pressure (Pcritgs) of the upper airway (cmH2O) during sleep with a polysomnography
Measured: From start of sleep to end of sleep of administration day (Day 1)

Secondary outcomes (2)

Incidence of treatment-emergent adverse events (TEAEs)
Measured: From first application of study intervention up to 2 days after end of treatment with study intervention in each period
Severity of treatment-emergent adverse events (TEAEs)
Measured: From first application of study intervention up to 2 days after end of treatment with study intervention in each period

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

4 Feb 202024 Jun 2021

First posted22 Jan 2020
Study start4 Feb 2020
Primary completion6 May 2021
Study completion24 Jun 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Sleep Apnea, ObstructiveStudies of the same condition, open and under way.
More trials run by BayerThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Model description: Part A: placebo-controlled 2-way crossover Part B: fixed single sequence Part C: single group, single dose
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 14 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04236440
Sponsor's protocol ID: 20732
Acronym: KOALA
Status last verified: Aug 2022
First submitted: 21 Jan 2020
Last updated: 8 Aug 2022
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: Availability of this study's data will be later determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.

Publications

Osman AM, Mukherjee S, Altree TJ, Delbeck M, Gehring D, Hahn M, Lang T, Xing C, Muller T, Weimann G, Eckert DJ. Topical Potassium Channel Blockage Improves Pharyngeal Collapsibility: A Translational, Placebo-Controlled Trial. Chest. 2023 Apr;163(4):953-965. doi: 10.1016/j.chest.2022.11.024. Epub 2022 Nov 24.
PubMed 36435266

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
Development and Validation of a Multimodal Deep Learning Model Using Peripheral Oxygen Saturation and Ballistocardiography Signals for Predicting Apnea-Hypopnea Index in Obstructive Sleep Apnea
Obstructive Sleep Apnea
RecruitingPhase 3
A Study to Learn About the Monthly Dosing Study Medicine Called Berobenatide in Adults With Breathing Problems During Sleep and Overweight or Obesity Who Do Not Use a Breathing Machine (PAP) (VESPER-OSA 2)
Apnea, Sleep Disorders
Not yet recruitingPhase 2
Supplemental Oxygen for Sleep-Disordered Breathing in Adults With Chronic Opioid Use.
Sleep-disordered Breathing, Chronic Opioid Use
Recruiting
Nightly Wearable Monitoring During Home-Based Submental Electrical Stimulation for Obstructive Sleep Apnea
Obstructive Sleep Apnea
RecruitingPhase 1/2
DRonabinol Treatment of OSA
Obstructive Sleep Apnea

All Sleep Apnea, Obstructive trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Proof-of-mechanism Single-center, Randomized, Double-blind, Placebo-controlled 2-way Crossover Study to Investigate Pharmacodynamics, Safety, Tolerability and Exposure of BAY 2586116 (Part A) and an Open-label Comparison of Different Application Modes for Single Nasal/Pharyngeal Dose Administrations (Part B and Part C) in 12 Participants With Obstructive Sleep Apnea
ClinicalTrials.gov ID: NCT04236440
Acronym / sponsor ID: KOALA / 20732
Conditions: Sleep Apnea, Obstructive
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 14 participants (actual)
Lead sponsor: BayerIndustry (pharma, biotech, devices)
Study start: 4 Feb 2020 (actual)
Primary completion: 6 May 2021 (actual)
Study completion: 24 Jun 2021 (actual)
First posted: 22 Jan 2020 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

They also want to find out if participants experience any medical problems during the study.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2
Model description: Part A: placebo-controlled 2-way crossover Part B: fixed single sequence Part C: single group, single dose

Arm	Type	Receives
Part A: A1A2+Part B+Part C	Experimental	Drug: BAY2586116 (A1), Drug: Placebo (A2), Drug: BAY2586116 (B1), Drug: BAY2586116 (B2), Drug: BAY2586116 (B3), Drug: BAY2586116 (C)Part A: Participants will receive a single dose administration of BAY2586116 (A1) in treatment period 1, and a single dose administration of placebo (A2) in treatment period 2. Part B: After successfully completing Part A, participants will proceed to Part B of the study. Participants will receive a single dose administration of BAY2586116 (B1) in treatment period 3. Based on the result of the interim analysis there are two possible scenarios regarding mode of application and doses of BAY2586116 to be administered in treatment period 4: 1) a single dose administration of BAY2586116 (B2) Or 2) a single dose administration of BAY2586116 (B3). Part C: Participants completing Part B will be invited to participate in an additional treatment period with a single dose BAY2586116 (C).
Part A: A2A1+Part B+Part C	Experimental	Drug: BAY2586116 (A1), Drug: Placebo (A2), Drug: BAY2586116 (B1), Drug: BAY2586116 (B2), Drug: BAY2586116 (B3), Drug: BAY2586116 (C)Part A: Participants will receive a single dose administration of placebo (A2) in treatment period 1, and a single dose administration of BAY2586116 (A1) in treatment period 2. Part B: After successfully completing Part A, participants will proceed to Part B of the study. Participants will receive a single dose administration of BAY2586116 (B1) in treatment period 3. Based on the result of the interim analysis there are two possible scenarios regarding mode of application and doses of BAY2586116 to be administered in treatment period 4: 1) a single dose administration of BAY2586116 (B2) Or 2) a single dose administration of BAY2586116 (B3). Part C: Participants completing Part B will be invited to participate in an additional treatment period with a single dose BAY2586116 (C).

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (13 listed)

Participant must be 18 years of age or above at the time of signing the informed consent.
Participants need to be diagnosed with OSA but should be considered otherwise healthy at the discretion of the investigator.
Participants do not need to be on CPAP therapy at the time of the study. However, if they are on therapy, participants must commit to keep their treatment schedule constant during the study period, especially the night before each administration of study intervention. For participants on CPAP, this will be monitored objectively using the compliance chip within the CPAP devices.
Female of non-child bearing potential or male.
Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.

Key exclusion criteria (10 listed)

Severely impaired breathing within two days prior to randomization (e.g. acute nasal congestion during upper airway infection).
Subject with known allergies or hypersensitivities to the study drugs (active substances or excipients of the preparations).
Any other condition which at the discretion of the investigator would make the participant unsuitable for participation in the study and will not allow participation for the full planned study period (e.g. active malignancy or other condition limiting life expectancy to less than 12 months).
Use of any topical medication containing local anesthetics for nose and throat within 2 days before each administration of study intervention.
Donation of more than 100 mL of plasma or equivalent volume of blood within 4 weeks or 500 mL whole blood within 3 months before study drug administration.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
BAY2586116 (A1)160 μg BAY2586116 (nasal spray administration)	Drug	Part A: A1A2+Part B+Part C, Part A: A2A1+Part B+Part C
Placebo (A2)Placebo matching BAY2586116 (nasal spray administration)	Drug	Part A: A1A2+Part B+Part C, Part A: A2A1+Part B+Part C
BAY2586116 (B1)160 μg BAY2586116 (nasal drops)	Drug	Part A: A1A2+Part B+Part C, Part A: A2A1+Part B+Part C
BAY2586116 (B2)80 μg BAY2586116 (nasal spray)	Drug	Part A: A1A2+Part B+Part C, Part A: A2A1+Part B+Part C
BAY2586116 (B3)160 μg BAY2586116 (pharyngeal spray with direct endoscopic application via a nostril)	Drug	Part A: A1A2+Part B+Part C, Part A: A2A1+Part B+Part C
BAY2586116 (C)160 μg BAY2586116 (pharyngeal spray with direct endoscopic application via a nostril). It is the same procedure as described under part B3.	Drug	Part A: A1A2+Part B+Part C, Part A: A2A1+Part B+Part C

Primary outcome

Critical closing pressure (Pcritgs) of the upper airway (cmH2O) during sleep with a polysomnography
Time frame: From start of sleep to end of sleep of administration day (Day 1)

2 secondary outcomes

Incidence of treatment-emergent adverse events (TEAEs)
Time frame: From first application of study intervention up to 2 days after end of treatment with study intervention in each period
Severity of treatment-emergent adverse events (TEAEs)
Time frame: From first application of study intervention up to 2 days after end of treatment with study intervention in each period

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2022.
Derived from this study: PubMed 36435266Osman AM, Mukherjee S, Altree TJ, Delbeck M, Gehring D, Hahn M, Lang T, Xing C, Muller T, Weimann G, Eckert DJ. Topical Potassium Channel Blockage Improves Pharyngeal Collapsibility: A Translational, Placebo-Controlled Trial. Chest. 2023 Apr;163(4):953-965. doi: 10.1016/j.chest.2022.11.024. Epub 2022 Nov 24.
Individual participant dataSharing planned: No. Availability of this study's data will be later determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.

Related trials for Sleep Apnea, Obstructive

RecruitingObservational study
Development and Validation of a Multimodal Deep Learning Model Using Peripheral Oxygen Saturation and Ballistocardiography Signals for Predicting Apnea-Hypopnea Index in Obstructive Sleep Apnea
Obstructive Sleep Apnea
RecruitingPhase 3
A Study to Learn About the Monthly Dosing Study Medicine Called Berobenatide in Adults With Breathing Problems During Sleep and Overweight or Obesity Who Do Not Use a Breathing Machine (PAP) (VESPER-OSA 2)
Apnea, Sleep Disorders
Not yet recruitingPhase 2
Supplemental Oxygen for Sleep-Disordered Breathing in Adults With Chronic Opioid Use.
Sleep-disordered Breathing, Chronic Opioid Use
Recruiting
Nightly Wearable Monitoring During Home-Based Submental Electrical Stimulation for Obstructive Sleep Apnea
Obstructive Sleep Apnea
RecruitingPhase 1/2
DRonabinol Treatment of OSA
Obstructive Sleep Apnea

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing BAY2586116 (A1), BAY2586116 (B1) and BAY2586116 (B2) in people with Sleep Apnea, Obstructive, run by Bayer at 1 site in Australia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Critical closing pressure (Pcritgs) of the upper airway (cmH2O) during sleep with a polysomnography (time frame: From start of sleep to end of sleep of administration day (Day 1)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04236440, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2022.