Sleep Apnea, Obstructive MedDRA version: 21.1 Level: LLT Classification code 10055577 Term: Obstructive sleep apnea syndrome System Organ Class: 100000004855
Conditions
Interventions
Product Name: BAY 2586116 nasal spray 0.4 mg/ml
Product Code: BAY 2586116
Pharmaceutical Form: Nasal spray, solution
INN or Proposed INN: na
CAS Number: na
Current Sponsor code: BAY 2586116
Other desc
Sponsors
Bayer AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - 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). - 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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 170 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 30
Exclusion criteria
Exclusion criteria: - 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 class III – IV at screening visit. - Uncontrolled arterial hypertension with DBP >110 mmHg or SBP >180 mmHg at screening visit. - 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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate the effect strength of BAY2586116 on obstructive sleep apnea (OSA) severity after repetitive doses compared to placebo;Secondary Objective: To analyze safety and tolerability of BAY2586116 after repetitive dose administrations;Primary end point(s): The difference in the responder rates where a response is defined as reduction of apnea-hypopnea index (AHI) from baseline by =50%;Timepoint(s) of evaluation of this end point: At day -1, and day 7 in Period 1, and day 7 in Period 2. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Number of participants with at least one treatment-emergent adverse event (TEAE) and maximum severity of TEAEs per participant;Timepoint(s) of evaluation of this end point: From first application of study intervention up to 2 days after end of treatment in each period with study intervention | — |
Countries
Germany, Switzerland
Contacts
Public ContactBayer Clinical Trials Contact
Bayer AG
Outcome results
None listed