Sleep Apnea, ObstructivePhase 2SPRAY-SMARTNCT04713826
A Trial to Learn More About How Well BAY2586116 Works and How Safe it is in Participants With Moderate to Severe Obstructive Sleep Apnea
A Phase 2 study testing BAY2586116 in people with Sleep Apnea, Obstructive, run by Bayer at 3 sites in 2 countries.
Trial summary
Researchers are looking for a better way to treat people with obstructive sleep apnea (OSA). In people with OSA, the upper airways can narrow or close repetitively while sleeping. These breathing interruptions lead to reduction of oxygen in the blood or short arousals from sleep. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sleep Apnea, Obstructive
- What is being tested?
- BAY2586116
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 93 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 3 Mar 2021to 11 Nov 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
- A participant must be at least 18 years of age, at the time of signing the informed consent.
- Participants need to be diagnosed with OSA.
- 15 ≤ AHI ≤ 60 per hour documented by baseline PSG (evaluated by NOX software; manual overreading by site staff possible) and after ≥72 hours of stop of specific OSA therapy. (One re-testing allowed if e.g. sleep time is less than 4 hours or e.g. due to technical problems with PSG measurement).
- Male and/or female with non-childbearing potential. Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
- Male participants: Men of reproductive potential must agree to use at least two adequate contraception methods when sexually active.
- Female participants: Female participants must be of non-childbearing potential, i.e. post-menopausal (no menses for at least 1 year) or surgically sterile (tubal ligation, hysterectomy, bilateral salpingectomy or bilateral oophorectomy).
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- Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.
- Ability to understand and follow study-related instructions.
- Informed consent must be signed before any study specific tests or procedures are done.
Who cannot join
- Not predominantly OSA evidenced at baseline, as judged by the investigator.
- Severely impaired breathing within two days prior to randomization (e.g. acute nasal congestion during upper airway infection).
- Participant with known allergies or hypersensitivities to the study interventions (active substances or excipients of the preparations). Known severe respiratory tract allergies e.g. allergic asthma.
- Suspected or proven active SARS-CoV-2 infection, as judged by the investigator
- Subjects with a clinical diagnosis of chronic heart failure with New York Heart Association (NYHA) class III - IV as judged by the investigator at screening visit.
- Uncontrolled arterial hypertension with diastolic blood pressure (DBP) >110 mmHg or systolic blood pressure (SBP) >180 mmHg at screening visit.
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- Chronic obstructive pulmonary disease (COPD) with more than one exacerbation during the last 12 months prior to screening visit.
- Previous assignment to a study intervention during this study.
- Participation in another trial with an investigational drug within 30 days or 5 half-lives of the investigational drug, whichever is longer before first application of study intervention or concomitant participation in another clinical study with investigational medicinal product(s).
- Heavy smoking, i.e. more than 20 cigarettes or equivalent per day and/or unable to stop smoking during the stay in the sleep laboratory.
- Suspicion of drug or alcohol abuse.
- Regular daily consumption of more than 1 L of xanthine-containing beverages.
- Inability to comply with planned study procedures or to comply with study protocol requirements; this includes completing required data collection and attending required end of study/follow up study visits.
- Any other condition, which would make the participant unsuitable for this 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).
- Close affiliation with the investigational site; e.g. a close relative of the investigator, dependent person (e.g. employee or student of the investigational site).
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
Germany2 sites
Advanced Sleep Research GmbH
Berlin, 10117
Ruhrlandklinik, Westdeutsches Lungenzentrum
Essen, North Rhine-Westphalia, 45239
About this study
Official title: Proof-of-concept, Multi-center, Randomized, Double-blind, Placebo-controlled, Two-way Crossover Study to Investigate the Effect Strength of BAY 2586116 on the Apnea-hypopnea-index After Repetitive Nasal Doses Compared to Placebo in 80 Valid Participants With Moderate to Severe Obstructive Sleep Apnea
Researchers are looking for a better way to treat people with obstructive sleep apnea (OSA). In people with OSA, the upper airways can narrow or close repetitively while sleeping. These breathing interruptions lead to reduction of oxygen in the blood or short arousals from sleep. Before a treatment can be approved for people to take, researchers do clinical trials to better understand its safety and how well it works.
In this trial, the researchers want to learn more about how well BAY2586116 works in a small number of participants with OSA. The trial will include about 160 men and women who have OSA and are at least 18 years old. Women can only be included in this trial if they are not able to have children naturally.
Read more
In this trial, the participants will take BAY2586116 and a placebo. A placebo looks like a treatment but does not have any medicine in it. All of the participants will take BAY2586116 through a nasal spray. They will also take the placebo as a nasal spray.
This will be a crossover trial. This means all the participants will take both trial treatments one after the other, but in a different order. The participants will take each treatment once a day for 7 days.
The researchers will use a measurement called the apnea-hypopnea-index (AHI) to measure the severity of the participants' OSA. The researchers will then compare the participants' AHI scores when they take BAY2586116 and when they take the placebo.
During study, the participants will visit their trial site 5 times. At these visits the doctors will take blood samples, do physical examinations and check the participants' heart health using an electrocardiogram (ECG). They will also ask the participants questions about how they are feeling and if they have any medical problems. At 3 of the visits, the participants will stay at the trial site overnight. At these visits, the doctors will calculate the number of times the participants stop breathing per hour of sleep. After treatment, the participants will have a final visit 7 days later so the doctors can check their health.
- Conditions
- Sleep Apnea, Obstructive
- Being tested
- BAY2586116, Placebo
- Keywords
- Obstructive sleep apnea, OSA, AHI, Sleep lab, PSG
- 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.
BAY2586116Drug
160 µg, nasal spray administration.
PlaceboDrug
Placebo matching BAY2586116, nasal spray administration.
| Study group | Role | What they receive |
|---|---|---|
| BAY2586116_Placebo | Experimental | Male or female participants aged above or equal to 18 years diagnosed with moderate to severe OSA will be allocated randomly to this intervention sequence.
Participants will receive BAY2586116 in treatment period 1, and placebo in treatment period 2.
Each intervention will be applied at home for 6 days (+1 optional day) followed by one in-house application for the overnight PSG (polysomnography).
In total, each participant will receive up to a maximum of 7 single doses (8 single doses if optional day is used) of BAY2586116 and up to 7 single doses of placebo (8 single doses if optional day is used). Receives: Drug: BAY2586116; Drug: Placebo |
| Placebo_BAY2586116 | Experimental | Male or female participants aged above or equal to 18 years diagnosed with moderate to severe OSA will be allocated randomly to this intervention sequence.
Participants will receive placebo in treatment period 1, and BAY2586116 in treatment period 2.
Each intervention will be applied at home for 6 days (+1 optional day) followed by one in-house application for the overnight PSG.
In total, each participant will receive up to a maximum of 7 single doses (8 single doses if optional day is used) of BAY2586116 and up to 7 single doses of placebo (8 single doses if optional day is used). Receives: Drug: BAY2586116; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Responder rates for BAY2586116 and placebo
A response is defined as reduction of apnea-hypopnea index (AHI) from baseline by ≥50%
Measured: At day -1, and day 7 in Period 1, and day 7 in Period 2
Secondary outcomes (1)
Number of participants with at least one treatment-emergent adverse event (TEAE) and maximum severity of TEAEs per participant
Measured: From first application of study intervention up to 2 days after end of treatment in each period with study intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2021
- Study start3 Mar 2021
- Primary completion17 Aug 2021
- Study completion11 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04713826
- Sponsor's protocol ID
- 20849
- Other IDs
- 2020-000520-19
- Acronym
- SPRAY-SMART
- Status last verified
- Oct 2022
- First submitted
- 15 Jan 2021
- Last updated
- 26 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Availability of this study's data will later be 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.
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Proof-of-concept, Multi-center, Randomized, Double-blind, Placebo-controlled, Two-way Crossover Study to Investigate the Effect Strength of BAY 2586116 on the Apnea-hypopnea-index After Repetitive Nasal Doses Compared to Placebo in 80 Valid Participants With Moderate to Severe Obstructive Sleep Apnea
- ClinicalTrials.gov ID
- NCT04713826
- Acronym / sponsor ID
- SPRAY-SMART / 20849
- Conditions
- Sleep Apnea, Obstructive
- Keywords
- Obstructive sleep apnea, OSA, AHI, Sleep lab, PSG
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 93 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 3 Mar 2021 (actual)
- Primary completion
- 17 Aug 2021 (actual)
- Study completion
- 11 Nov 2021 (actual)
- First posted
- 19 Jan 2021 (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.
Researchers are looking for a better way to treat people with obstructive sleep apnea (OSA). In people with OSA, the upper airways can narrow or close repetitively while sleeping. These breathing interruptions lead to reduction of oxygen in the blood or short arousals from sleep. Before a treatment can be approved for people to take, researchers do clinical trials to better understand its safety and how well it works.
In this trial, the researchers want to learn more about how well BAY2586116 works in a small number of participants with OSA. The trial will include about 160 men and women who have OSA and are at least 18 years old. Women can only be included in this trial if they are not able to have children naturally.
In this trial, the participants will take BAY2586116 and a placebo. A placebo looks like a treatment but does not have any medicine in it. All of the participants will take BAY2586116 through a nasal spray. They will also take the placebo as a nasal spray.
This will be a crossover trial. This means all the participants will take both trial treatments one after the other, but in a different order. The participants will take each treatment once a day for 7 days.
The researchers will use a measurement called the apnea-hypopnea-index (AHI) to measure the severity of the participants' OSA. The researchers will then compare the participants' AHI scores when they take BAY2586116 and when they take the placebo.
During study, the participants will visit their trial site 5 times. At these visits the doctors will take blood samples, do physical examinations and check the participants' heart health using an electrocardiogram (ECG). They will also ask the participants questions about how they are feeling and if they have any medical problems. At 3 of the visits, the participants will stay at the trial site overnight. At these visits, the doctors will calculate the number of times the participants stop breathing per hour of sleep. After treatment, the participants will have a final visit 7 days later so the doctors can check their health.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BAY2586116_Placebo | Experimental | Drug: BAY2586116, Drug: PlaceboMale or female participants aged above or equal to 18 years diagnosed with moderate to severe OSA will be allocated randomly to this intervention sequence. Participants will receive BAY2586116 in treatment period 1, and placebo in treatment period 2. Each intervention will be applied at home for 6 days (+1 optional day) followed by one in-house application for the overnight PSG (polysomnography). In total, each participant will receive up to a maximum of 7 single doses (8 single doses if optional day is used) of BAY2586116 and up to 7 single doses of placebo (8 single doses if optional day is used). |
| Placebo_BAY2586116 | Experimental | Drug: BAY2586116, Drug: PlaceboMale or female participants aged above or equal to 18 years diagnosed with moderate to severe OSA will be allocated randomly to this intervention sequence. Participants will receive placebo in treatment period 1, and BAY2586116 in treatment period 2. Each intervention will be applied at home for 6 days (+1 optional day) followed by one in-house application for the overnight PSG. In total, each participant will receive up to a maximum of 7 single doses (8 single doses if optional day is used) of BAY2586116 and up to 7 single doses of placebo (8 single doses if optional day is used). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- A participant must be at least 18 years of age, at the time of signing the informed consent.
- Participants need to be diagnosed with OSA.
- 15 ≤ AHI ≤ 60 per hour documented by baseline PSG (evaluated by NOX software; manual overreading by site staff possible) and after ≥72 hours of stop of specific OSA therapy. (One re-testing allowed if e.g. sleep time is less than 4 hours or e.g. due to technical problems with PSG measurement).
- Male and/or female with non-childbearing potential. Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
- Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.
Key exclusion criteria (15 listed)
- Not predominantly OSA evidenced at baseline, as judged by the investigator.
- Severely impaired breathing within two days prior to randomization (e.g. acute nasal congestion during upper airway infection).
- Participant with known allergies or hypersensitivities to the study interventions (active substances or excipients of the preparations). Known severe respiratory tract allergies e.g. allergic asthma.
- Suspected or proven active SARS-CoV-2 infection, as judged by the investigator
- Subjects with a clinical diagnosis of chronic heart failure with New York Heart Association (NYHA) class III - IV as judged by the investigator at screening visit.
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 |
|---|---|---|
| BAY2586116160 µg, nasal spray administration. | Drug | BAY2586116_Placebo, Placebo_BAY2586116 |
| PlaceboPlacebo matching BAY2586116, nasal spray administration. | Drug | BAY2586116_Placebo, Placebo_BAY2586116 |
Primary outcome
Responder rates for BAY2586116 and placebo
Time frame: At day -1, and day 7 in Period 1, and day 7 in Period 2
A response is defined as reduction of apnea-hypopnea index (AHI) from baseline by ≥50%
1 secondary outcome
Number of participants with at least one treatment-emergent adverse event (TEAE) and maximum severity of TEAEs per participant
Time frame: From first application of study intervention up to 2 days after end of treatment in each period with study intervention
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 26 Oct 2022.
- Click here to find information about studies related to Bayer Healthcare products conducted in Europe.Link provided by the sponsor.
- Individual participant dataSharing planned: No. Availability of this study's data will later be 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.
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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.
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing BAY2586116 in people with Sleep Apnea, Obstructive, run by Bayer at 3 sites in 2 countries.
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 9 inclusion and 15 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 26 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Germany, Switzerland. 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?
Responder rates for BAY2586116 and placebo (time frame: At day -1, and day 7 in Period 1, and day 7 in Period 2). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Oct 2022.