Sleep Apnea, ObstructivePhase 2SANDMANNCT03603678
Obstructive Sleep Apnea (OSA) Treated With a Potassium Channel Inhibitor
A Phase 2 study testing BAY2253651 in people with Sleep Apnea, Obstructive, run by Bayer at 2 sites in 2 countries.
Trial summary
The aim of this study in subjects with obstructive sleep apnea is to investigate pharmacodynamics, safety and tolerability after a single nasal administration of BAY2253651 and to evaluate first safety and tolerability of multiple dosing over 5 consecutive nights in OSA patients. 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?
- BAY2253651
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 13 Aug 2018to 2 Sep 2019
- 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
- Subjects need to be diagnosed with OSA (obstructive sleep apnea) but should be otherwise healthy at the discretion of the investigator.
- Patients must be pretreated with CPAP (continuous positive airway pressure) for OSA for at least 3 months before randomization.
- AHI of 15-50 per hour after 48 hours of CPAP withdrawal documented by baseline PSG (polysomnography, evaluated by the site staff) and at least 4 hours of total sleep time. (One retesting allowed).
- Female subjects must be of non-childbearing potential, i.e. post-menopausal (no menses for at least 1 year prior to randomization) or surgically sterile (tubal ligation, hysterectomy or bilateral oophorectomy)
- Men of reproductive potential together with their female partner(s) must agree to use at least two adequate contraception methods when sexually active. This applies for the time period between signing of the informed consent form and 3 months after the last administration of study drug.
- 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
- Only Part B: Patients having completed Part A and had valid PSG after dosing in Part A.
Who cannot join
- Inability to comply with planned study procedures or to comply with study protocol requirements; this includes completing required data collection and attending required follow up study visits.
- Neck circumference above/equal 44 cm.
- Not predominantly obstructive sleep apnea evidenced by baseline PSG.
- 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). Known severe respiratory tract allergies e.g. allergic asthma.
- Intake of a nasal decongestant during the intervention time (48 hours before visit 1 until end of visit 2).
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- Use of any topical medication containing local anesthetics for nose and throat within 7 days before first investigational medicinal product (IMP) administration.
- 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 drug or concomitant participation in another clinical study with investigational medicinal product(s).
- Any other condition, which would make the subject 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)
- Known history of severe heart failure (NYHA 3-4) or severe COPD (GOLD 3-4).
- Heavy smoking, i.e. more than 20 cigarettes 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.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: Randomized, Multi-center, Double-blind, Placebo-controlled, Group-comparison Study to Investigate Safety, Tolerability and Pharmacodynamics of BAY2253651 After Administration of a Single Nasal Dose in 60 Subjects With Obstructive Sleep Apnea and Open Exploratory Evaluation of Safety and Local Tolerability of Repeated Doses in Patients
The aim of this study in subjects with obstructive sleep apnea is to investigate pharmacodynamics, safety and tolerability after a single nasal administration of BAY2253651 and to evaluate first safety and tolerability of multiple dosing over 5 consecutive nights in OSA patients.
- Conditions
- Sleep Apnea, Obstructive
- Being tested
- BAY2253651, Placebo
- Keywords
- Obstructive sleep apnea, Potassium channel blocker, Polysomnography, 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.
BAY2253651Drug
100 µg (500 µg/ml * 200 µl) BAY2253651 intranasally
PlaceboDrug
Matching Placebo dosing
| Study group | Role | What they receive |
|---|---|---|
| Part A single dose BAY2253651 | Experimental | Single dose BAY2253651 Receives: Drug: BAY2253651 |
| Part A single dose Placebo | Placebo comparator | Single dose matching placebo Receives: Drug: Placebo |
| Part B multiple dose BAY2253651 | Experimental | Multiple dose BAY2253651 on 5 consecutive nights Receives: Drug: BAY2253651 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of responders, defined by reduction of apnoea-hypopnoea-index (AHI) from baseline by ≥ 50%
Measured: 2 days
Secondary outcomes (2)
Incidence of treatment emergent adverse events (TEAEs)
Measured: Up to 7 days
Severity of treatment emergent adverse events (TEAEs)
Measured: Up to 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2018
- Study start13 Aug 2018
- Primary completion23 May 2019
- Study completion2 Sep 2019
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
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03603678
- Sponsor's protocol ID
- 19038
- Other IDs
- 2017-001851-29, 2017
- Acronym
- SANDMAN
- Status last verified
- Dec 2020
- First submitted
- 21 Jun 2018
- Last updated
- 11 Dec 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Gaisl T, Turnbull CD, Weimann G, Unger S, Finger R, Xing C, Cistulli PA, West S, Chiang AKI, Eckert DJ, Stradling JR, Kohler M. BAY 2253651 for the treatment of obstructive sleep apnoea: a multicentre, double-blind, randomised controlled trial (SANDMAN). Eur Respir J. 2021 Nov 18;58(5):2101937. doi: 10.1183/13993003.01937-2021. Print 2021 Nov.
PubMed 34531274
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Multi-center, Double-blind, Placebo-controlled, Group-comparison Study to Investigate Safety, Tolerability and Pharmacodynamics of BAY2253651 After Administration of a Single Nasal Dose in 60 Subjects With Obstructive Sleep Apnea and Open Exploratory Evaluation of Safety and Local Tolerability of Repeated Doses in Patients
- ClinicalTrials.gov ID
- NCT03603678
- Acronym / sponsor ID
- SANDMAN / 19038
- Conditions
- Sleep Apnea, Obstructive
- Keywords
- Obstructive sleep apnea, Potassium channel blocker, Polysomnography, PSG
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 13 Aug 2018 (actual)
- Primary completion
- 23 May 2019 (actual)
- Study completion
- 2 Sep 2019 (actual)
- First posted
- 27 Jul 2018 (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.
The aim of this study in subjects with obstructive sleep apnea is to investigate pharmacodynamics, safety and tolerability after a single nasal administration of BAY2253651 and to evaluate first safety and tolerability of multiple dosing over 5 consecutive nights in OSA patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Part A single dose BAY2253651 | Experimental | Drug: BAY2253651Single dose BAY2253651 |
| Part A single dose Placebo | Placebo comparator | Drug: PlaceboSingle dose matching placebo |
| Part B multiple dose BAY2253651 | Experimental | Drug: BAY2253651Multiple dose BAY2253651 on 5 consecutive nights |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Subjects need to be diagnosed with OSA (obstructive sleep apnea) but should be otherwise healthy at the discretion of the investigator.
- Patients must be pretreated with CPAP (continuous positive airway pressure) for OSA for at least 3 months before randomization.
- AHI of 15-50 per hour after 48 hours of CPAP withdrawal documented by baseline PSG (polysomnography, evaluated by the site staff) and at least 4 hours of total sleep time. (One retesting allowed).
- Female subjects must be of non-childbearing potential, i.e. post-menopausal (no menses for at least 1 year prior to randomization) or surgically sterile (tubal ligation, hysterectomy or bilateral oophorectomy)
- Men of reproductive potential together with their female partner(s) must agree to use at least two adequate contraception methods when sexually active. This applies for the time period between signing of the informed consent form and 3 months after the last administration of study drug.
Key exclusion criteria (13 listed)
- Inability to comply with planned study procedures or to comply with study protocol requirements; this includes completing required data collection and attending required follow up study visits.
- Neck circumference above/equal 44 cm.
- Not predominantly obstructive sleep apnea evidenced by baseline PSG.
- 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). Known severe respiratory tract allergies e.g. allergic asthma.
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 |
|---|---|---|
| BAY2253651100 µg (500 µg/ml * 200 µl) BAY2253651 intranasally | Drug | Part A single dose BAY2253651, Part B multiple dose BAY2253651 |
| PlaceboMatching Placebo dosing | Drug | Part A single dose Placebo |
Primary outcome
Rate of responders, defined by reduction of apnoea-hypopnoea-index (AHI) from baseline by ≥ 50%
Time frame: 2 days
2 secondary outcomes
Incidence of treatment emergent adverse events (TEAEs)
Time frame: Up to 7 days
Severity of treatment emergent adverse events (TEAEs)
Time frame: Up to 7 days
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 11 Dec 2020.
- Derived from this study: PubMed 34531274Gaisl T, Turnbull CD, Weimann G, Unger S, Finger R, Xing C, Cistulli PA, West S, Chiang AKI, Eckert DJ, Stradling JR, Kohler M. BAY 2253651 for the treatment of obstructive sleep apnoea: a multicentre, double-blind, randomised controlled trial (SANDMAN). Eur Respir J. 2021 Nov 18;58(5):2101937. doi: 10.1183/13993003.01937-2021. Print 2021 Nov.
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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.
2 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 BAY2253651 in people with Sleep Apnea, Obstructive, run by Bayer at 2 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 7 inclusion and 13 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 11 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Switzerland, United Kingdom. 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. Some participants in this study may receive a placebo. 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?
Rate of responders, defined by reduction of apnoea-hypopnoea-index (AHI) from baseline by ≥ 50% (time frame: 2 days). 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 NCT03603678, 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 11 Dec 2020.