Clinical Study to Evaluate the Efficacy and Safety of Three Different Doses of BAY1817080 Compared to Placebo in Patients With Chronic Cough

NCT04562155 | Completed Phase 2 Results FDA Drug

• 2 other identifiers: 203932019-004169-42
• Study Type: interventional
• Target: 310
• Locations: 19 countries
• Sites: 99

Brief Summary

Researchers in this study want to find the optimal therapeutic dose of drug BAY1817080 for patients with long-standing cough with or without clear causes (refractory and/or unexplained chronic cough, RUCC). Study drug BAY1817080 is a new drug under development for the treatment of long-standing cough. It blocks proteins that are expressed by the airway sensory nerves which are oversensitive in patients with long-standing cough. This prevents the urge to cough. Researchers also want to learn the safety of the study drug and how well it works in reducing the cough frequency, severity and urge-to-cough. Participants in this study will receive either the study drug or placebo (a placebo looks like the test drug but does not have any medicine in it) tablets twice daily for 12 weeks. Observation for each participant will last about 18 weeks in total. Participants will be asked to wear a digital device to record the cough and to complete questionnaires every day to document the symptoms. Blood samples will be collected from the participants to monitor the safety and measure the blood level of the study drug.

Conditions

Refractory and/or Unexplained Chronic Cough

Keywords

RUCC; Chronic cough; P2X3 receptor antagonist

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in 24-hour Cough Count After 12 Weeks of Intervention

  The raw 24-hour cough count measured by cough recording digital wearable monitoring device was standardized to an average hourly count. For the ratio between the geometric means of 24-hour cough count, the geometric mean of 24-hour cough count after 12 weeks of intervention was divided by the geometric mean of 24-hour cough count at baseline. btw = between geo = geometric

  From baseline up to 12 weeks

Secondary Outcomes (8)

• Percentage of Participants With a ≥30% Reduction From Baseline in 24-hour Cough Count After 12 Weeks of Intervention

  From baseline up to 12 weeks

• Change From Baseline in 24-hour Cough Count After 2, 4, and 8 Weeks of Intervention

  From baseline up to 2 weeks, 4 weeks and 8 weeks

• Change From Baseline in Awake Cough Frequency Per Hour After 2, 4, 8 and 12 Weeks of Intervention

  From baseline up to 2 weeks, 4 weeks, 8 weeks and 12 weeks

• Change From Baseline in Cough Related Quality of Life After 12 Weeks of Intervention

  From baseline up to 12 weeks

• Change From Baseline in Cough Severity After 12 Weeks of Intervention

  From baseline up to 12 weeks

Study Arms (4)

BAY1817080 dose A BID

EXPERIMENTAL

Each participant will be randomized to receive one of three oral doses of BAY 1817080 or placebo, administered twice daily over the course of 12 weeks.

Drug: BAY1817080

BAY1817080 dose B BID

EXPERIMENTAL

Each participant will be randomized to receive one of three oral doses of BAY 1817080 or placebo, administered twice daily over the course of 12 weeks.

Drug: BAY1817080

BAY1817080 dose C BID

EXPERIMENTAL

Each participant will be randomized to receive one of three oral doses of BAY 1817080 or placebo, administered twice daily over the course of 12 weeks.

Drug: BAY1817080

Placebo

PLACEBO COMPARATOR

Each participant will be randomized to receive one of three oral doses of BAY 1817080 or placebo, administered twice daily over the course of 12 weeks.

Drug: Placebo

Interventions

BAY1817080 DRUG

Study drug BAY1817080 will be administered orally as tablet.

BAY1817080 dose A BID; BAY1817080 dose B BID; BAY1817080 dose C BID

Placebo DRUG

Matching Placebo for BAY1817080 will be administered orally as tablet.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults ≥ 18 years of age at the time of signing the informed consent.
• A cough that has lasted for at least 12 months (unresponsive to treatment options) with a diagnosis of refractory chronic cough and/or idiopathic (unexplained) chronic cough.
• Persistent cough for at least the last 8 weeks before screening.
• Women of childbearing potential must agree to use acceptable effective or highly effective birth control methods during the study and for at least 30 days after the last dose.
• Capable of giving signed informed consent.

You may not qualify if:

• Smoking history within the last 12 months before screening (all forms of smoking, including e-cigarettes, cannabis and others), and any former smoker with more than 20 pack-years.
• Ongoing or previous exposure to inhalational toxic fumes (e.g., ammonia, chlorine, nitrogen dioxide, phosgene and sulfur dioxide) within the last 12 months before screening.
• Respiratory tract infection within 4 weeks before screening.
• History of chronic bronchitis.
• Systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure ≥ 100 mmHg at screening visit.
• Positive SARS-CoV-2 virus RNA and/or serology IgG tests at screening visit.

Sponsors & Collaborators

• Bayer: lead

Study Sites (99)

California Allergy & Asthma Medical Group & Research Center

Los Angeles, California, 90025, United States

Location

Florida Pediatrics

Largo, Florida, 33778, United States

Location

Chesapeake Clinical Research, Inc.

White Marsh, Maryland, 21162, United States

Location

Minnesota Lung Center

Edina, Minnesota, 55435, United States

Location

Montana Medical Research, Inc

Missoula, Montana, 59808, United States

Location

Vanderbilt University Medical School

Nashville, Tennessee, 37212-1610, United States

Location

Pharmaceutical Research & Consulting, Inc.

Dallas, Texas, 75231, United States

Location

Bellingham Asthma, Allergy & Immunology Clinic

Bellingham, Washington, 98225, United States

Location

Instituto Ave Pulmo

Mar del Plata, Buenos Aires, Argentina

Location

Centro Respiratorio Quilmes

Quilmes, Buenos Aires, Argentina

Location

Centro Médico Dra. De Salvo - Clinical Research Center

Buenos Aires, Ciudad Auton. de Buenos Aires, C1426ABP, Argentina

Location

Centro de Investigaciones Clínicas

CABA, Ciudad Auton. de Buenos Aires, C1018DES, Argentina

Location

Fundación CIDEA

CABA, Ciudad Auton. de Buenos Aires, C1121ABE, Argentina

Location

Investigación en Alergias y Enfermedades Respiratorias-INAER

CABA, Ciudad Auton. de Buenos Aires, C1425, Argentina

Location

Investigaciones en Patologías Respiratorias

San Miguel de Tucumán, Tucumán Province, Argentina

Location

Macquarie University Hospital

Macquarie University, New South Wales, 2109, Australia

Location

Maroubra Medical Centre

Maroubra, New South Wales, 2035, Australia

Location

Holdsworth House Medical Practice

Sydney, New South Wales, 2010, Australia

Location

Royal Adelaide Hospital

Adelaide, South Australia, 5000, Australia

Location

Western Respiratory Trial Specialists

Spearwood, Western Australia, 6163, Australia

Location

Dr. MARTINOT Jean-Benoît

Erpent, 5101, Belgium

Location

UZ Gent

Ghent, 9000, Belgium

Location

UZ Leuven Gasthuisberg

Leuven, 3000, Belgium

Location

CHU de Liège

Liège, 4000, Belgium

Location

VZW Emmaus

Mechelen, 2800, Belgium

Location

Burlington Lung Clinic (BLC) Clinical Research

Burlington, Ontario, L7N 3V2, Canada

Location

Clinique de pneumologie et du sommeil de Lanaudière (CPSL)

Saint-Charles-Borromée, Quebec, J6E 2B4, Canada

Location

MUDr Otakar Hokynar - Plicni ambulance

Kralupy nad Vltavou, 278 01, Czechia

Location

Ordinace pro TBC a respiracni nemoci, s.r.o.

Olomouc, 772 00, Czechia

Location

Dawon s.r.o.

Prague, 14800, Czechia

Location

Plicní stredisko Teplice, s.r.o.

Teplice, 415 01, Czechia

Location

MUDr. Milan Sklenar

Varnsdorf, 407 47, Czechia

Location

Cochin - Paris

Paris, 75674, France

Location

CHU de Toulouse - Hôpital Larrey

Toulouse, 31059, France

Location

Klinikum Konstanz

Konstanz, Baden-Wurttemberg, 78464, Germany

Location

Zentrum f. ambulante pneumologische Forschung Marburg GbR

Marburg, Hesse, 35037, Germany

Location

Ballenberger, Freytag, Wenisch

Neu-Isenburg, Hesse, 63263, Germany

Location

Pneumologicum im Südstadt Forum

Hanover, Lower Saxony, 30173, Germany

Location

Medizinische Hochschule Hannover (MHH)

Hanover, Lower Saxony, 30625, Germany

Location

Priv.-Doz. Dr. med. Christian Gessner

Leipzig, Saxony, 04357, Germany

Location

Praxis f. Lungen- und Bronchialheilkunde,

Berlin, 10717, Germany

Location

D.Kenessey A Hospital

Balassagyarmat, 2660, Hungary

Location

EKBC, Uj Szent Janos Korhaz es Szakrendelo

Budapest, 1122, Hungary

Location

Erzsebet Gondozohaz

Gödöllő, 2100, Hungary

Location

Da Vinci Maganklinika

Pécs, 7635, Hungary

Location

Farmakontroll Bt.

Százhalombatta, 2440, Hungary

Location

ASST Lodi

Lodi, Lombardy, 26845, Italy

Location

A.O.U. Careggi

Florence, Tuscany, 50134, Italy

Location

IRCCS Ospedale Sacro Cuore Don Calabria

Verona, Veneto, 37024, Italy

Location

A.O.U.I. Verona

Verona, Veneto, 37126, Italy

Location

Nagoya City University Hospital

Nagoya, Aichi-ken, 467-8602, Japan

Location

University of Fukui Hospital

Yoshida, Fukui, 910-1193, Japan

Location

University of Occupational and Environmental Health

Kitakyushu, Fukuoka, 807-8556, Japan

Location

Idaimae Minami Yojo

Sapporo, Hokkaido, 064-0804, Japan

Location

Japan community health care organization Kanazawa Hospital

Kanazawa, Ishikawa-ken, 920-8610, Japan

Location

Komatsu Municipal Hospital

Komatsu, Ishikawa-ken, 923-8560, Japan

Location

Yokohama City Minato Red Cross Hospital

Yokohama, Kanagawa, 231-8682, Japan

Location

Saiseikai Yokohamashi Nanbu Hospital

Yokohama, Kanagawa, 234-8503, Japan

Location

Matsusaka Municipal Hospital

Matsusaka, Mie-ken, 515-8544, Japan

Location

Hamamatsu Rosai Hospital

Hamamatsu, Shizuoka, 430-8525, Japan

Location

Tokyo Shinagawa Hospital

Shinagawa-ku, Tokyo, 140-8522, Japan

Location

Fukushima Medical University Hospital

Fukushima, 960-1295, Japan

Location

Catharina Ziekenhuis

Eindhoven, North Brabant, 5623 EJ, Netherlands

Location

Isala

Zwolle, 8025 AB, Netherlands

Location

Centrum Medycyny Oddechowej Mroz Spolka Jawna

Bialystok, 15-044, Poland

Location

KLIMED Marek Klimkiewicz

Bychawa, 23-100, Poland

Location

Centrum Alergologii Sp. z o.o.

Lublin, 20-552, Poland

Location

Ostrowieckie Centrum Medyczne Sp. Cyw. A.O-C. K.C.

Ostrowiec Świętokrzyski, 27-400, Poland

Location

Centrum Medyczne Lucyna Andrzej Dymek

Strzelce Opolskie, 47-100, Poland

Location

Region Clinical Emergency Hospital n.a. M.A.Podgorbunskogo

Kemerovo, 650000, Russia

Location

City Clinical Hospital n.a. D.D. Pletnev

Moscow, 105077, Russia

Location

LLC "Medical Center "SibNovoMed""

Novosibirsk, 630005, Russia

Location

City Consultative and Diagnostic Center #1

Saint Petersburg, 194354, Russia

Location

LLC Astarta

Saint Petersburg, 199226, Russia

Location

City Clinical Hospital #4 Samara

Samara, 453056, Russia

Location

Voronezh Regional Clinical Hospital #1

Voronezh, 394066, Russia

Location

ALIAN s.r.o.

Bardejov, 085 01, Slovakia

Location

INSPIRO, s.r.o.

Humenné, 066 01, Slovakia

Location

AlergoImunocentrum, s.r.o.

Kežmarok, 060 01, Slovakia

Location

Plucna ambulancia s.r.o.

Poprad, 058 01, Slovakia

Location

Ambulancia klin. imunologie a alergologie, ANA JJ, s.r.o.

Topoľčany, 955 01, Slovakia

Location

Hospital Clínico Universitario de Santiago de Compostela

Santiago de Compostela, A Coruña, 15706, Spain

Location

Hospital Universitari Germans Trias i Pujol

Badalona, Barcelona, 08916, Spain

Location

Hospital Clínic i Provincial de Barcelona

Barcelona, 08036, Spain

Location

Chang Gung Memorial Hospital Keelung

Keelung, 20401, Taiwan

Location

Far Eastern Memorial Hospital

New Taipei City, 220, Taiwan

Location

Taichung Veterans General Hospital

Taichung, 40705, Taiwan

Location

National Taiwan University Hospital

Taipei, 100, Taiwan

Location

Taipei Medical University Hospital

Taipei, 110, Taiwan

Location

Akdeniz Universitesi Tip Fakultesi Hastanesi

Antalya, 07058, Turkey (Türkiye)

Location

Istanbul Universitesi Cerrahpasa-Cerrahpasa Tip Fakultesi

Istanbul, 34098, Turkey (Türkiye)

Location

Ege Universitesi Tip Fakultesi

Izmir, 35100, Turkey (Türkiye)

Location

Sureyyapasa Gogus Hasalikleri. ve Gogus Cerrahisi EAH

Maltepe, 34844, Turkey (Türkiye)

Location

Mersin Universitesi Tip Fakultesi

Mersin, 33343, Turkey (Türkiye)

Location

North Tyneside General Hospital

North Shields, Tyne and Wear, NE29 8NH, United Kingdom

Location

West Walk Surgery

Bristol, BS37 4AX, United Kingdom

Location

Castle Hill Hospital

Cottingham, HU16 5JQ, United Kingdom

Location

King's College Hospital - NHS Foundation Trust

London, SE5 9RS, United Kingdom

Location

University Hospital of South Manchester

Manchester, M23 9LT, United Kingdom

Location

Related Publications (3)

• Fletcher MC. Selectivity of the P2X3 receptor antagonist Eliapixant, and its potential use in the treatment of endometriosis. Purinergic Signal. 2022 Mar;18(1):1-3. doi: 10.1007/s11302-021-09831-5. Epub 2022 Jan 3. No abstract available.

  PMID: 34978027 BACKGROUND

• Trigg A, Clarke N, Gerlinger C, Krahn U, Gater A, Haberland C. Psychometric validation of the severity of chronic cough diary, leicester cough questionnaire, and a cough severity visual analogue scale in patients with refractory chronic cough. J Patient Rep Outcomes. 2025 Jun 11;9(1):65. doi: 10.1186/s41687-025-00888-z.

  PMID: 40498172 DERIVED

• Dicpinigaitis PV, Morice AH, Smith JA, Sher MR, Vaezi M, Guilleminault L, Niimi A, Gude K, Krahn U, Saarinen R, Pires PV, Wosnitza M, McGarvey L; PAGANINI Investigators. Efficacy and Safety of Eliapixant in Refractory Chronic Cough: The Randomized, Placebo-Controlled Phase 2b PAGANINI Study. Lung. 2023 Jun;201(3):255-266. doi: 10.1007/s00408-023-00621-x. Epub 2023 Jun 1.

  PMID: 37261531 DERIVED

Related Links

• Click here to find results for studies related to Bayer products
• Click here to find information about studies related to Bayer Healthcare products conducted in Europe

MeSH Terms

Conditions

Chronic Cough

Condition Hierarchy (Ancestors)

Cough; Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Therapeutic Area Head
• Organization: Bayer AG

clinical-trials-contact@bayer.com

(+) 1-888-8422937

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2020
• First Posted: September 24, 2020
• Study Start: October 2, 2020
• Primary Completion: June 22, 2021
• Study Completion: July 23, 2021
• Last Updated: August 18, 2022
• Results First Posted: August 18, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (5); SL (5); JP (12); BE (5); CA (2); FR (2); GB (5); CZ (5); PL (5); ES (3); US (8); AR (7); DE (7); AU (5); TW (5); IT (4); NL (2); RU (7); HU (5)