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Refractory and/or Unexplained Chronic CoughPhase 2PAGANININCT04562155

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

A Phase 2 study testing BAY1817080 in people with Refractory and/or Unexplained Chronic Cough, run by Bayer at 99 sites in 19 countries.

Completed

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

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
BAY1817080
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
310 participants
Where
99 sitesin 19 countries
Study dates
2 Oct 2020to 23 Jul 2021
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

99 sites in 19 countries.

99 sites in 19 countries

Japan12 sites

  • Fukushima Medical University Hospital

    Fukushima, 960-1295

  • Hamamatsu Rosai Hospital

    Hamamatsu, Shizuoka, 430-8525

  • Japan community health care organization Kanazawa Hospital

    Kanazawa, Ishikawa-ken, 920-8610

  • University of Occupational and Environmental Health

    Kitakyushu, Fukuoka, 807-8556

  • Komatsu Municipal Hospital

    Komatsu, Ishikawa-ken, 923-8560

  • Matsusaka Municipal Hospital

    Matsusaka, Mie-ken, 515-8544

  • Nagoya City University Hospital

    Nagoya, Aichi-ken, 467-8602

  • Idaimae Minami Yojo

    Sapporo, Hokkaido, 064-0804

  • Tokyo Shinagawa Hospital

    Shinagawa-ku, Tokyo, 140-8522

  • Yokohama City Minato Red Cross Hospital

    Yokohama, Kanagawa, 231-8682

  • Saiseikai Yokohamashi Nanbu Hospital

    Yokohama, Kanagawa, 234-8503

  • University of Fukui Hospital

    Yoshida, Fukui, 910-1193

Other trials in Japan

United States8 sites

  • Bellingham Asthma, Allergy & Immunology Clinic

    Bellingham, Washington, 98225

  • Pharmaceutical Research & Consulting, Inc.

    Dallas, Texas, 75231

  • Minnesota Lung Center

    Edina, Minnesota, 55435

  • Florida Pediatrics

    Largo, Florida, 33778

  • California Allergy & Asthma Medical Group & Research Center

    Los Angeles, California, 90025

  • Montana Medical Research, Inc

    Missoula, Montana, 59808

  • Vanderbilt University Medical School

    Nashville, Tennessee, 37212-1610

  • Chesapeake Clinical Research, Inc.

    White Marsh, Maryland, 21162

Other trials in United States

Argentina7 sites

  • Centro Médico Dra. De Salvo - Clinical Research Center

    Buenos Aires, Ciudad Auton. de Buenos Aires, C1426ABP

  • Centro de Investigaciones Clínicas

    CABA, Ciudad Auton. de Buenos Aires, C1018DES

  • Fundación CIDEA

    CABA, Ciudad Auton. de Buenos Aires, C1121ABE

  • Investigación en Alergias y Enfermedades Respiratorias-INAER

    CABA, Ciudad Auton. de Buenos Aires, C1425

  • Instituto Ave Pulmo

    Mar del Plata, Buenos Aires

  • Centro Respiratorio Quilmes

    Quilmes, Buenos Aires

  • Investigaciones en Patologías Respiratorias

    San Miguel de Tucumán, Tucumán Province

Other trials in Argentina

Germany7 sites

  • Praxis f. Lungen- und Bronchialheilkunde,

    Berlin, 10717

  • Pneumologicum im Südstadt Forum

    Hanover, Lower Saxony, 30173

  • Medizinische Hochschule Hannover (MHH)

    Hanover, Lower Saxony, 30625

  • Klinikum Konstanz

    Konstanz, Baden-Wurttemberg, 78464

  • Priv.-Doz. Dr. med. Christian Gessner

    Leipzig, Saxony, 04357

  • Zentrum f. ambulante pneumologische Forschung Marburg GbR

    Marburg, Hesse, 35037

  • Ballenberger, Freytag, Wenisch

    Neu-Isenburg, Hesse, 63263

Other trials in Germany

Russia7 sites

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

    Kemerovo, 650000

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

    Moscow, 105077

  • LLC "Medical Center "SibNovoMed""

    Novosibirsk, 630005

  • City Consultative and Diagnostic Center #1

    Saint Petersburg, 194354

  • LLC Astarta

    Saint Petersburg, 199226

  • City Clinical Hospital #4 Samara

    Samara, 453056

  • Voronezh Regional Clinical Hospital #1

    Voronezh, 394066

Other trials in Russia

Australia5 sites

  • Royal Adelaide Hospital

    Adelaide, South Australia, 5000

  • Macquarie University Hospital

    Macquarie University, New South Wales, 2109

  • Maroubra Medical Centre

    Maroubra, New South Wales, 2035

  • Western Respiratory Trial Specialists

    Spearwood, Western Australia, 6163

  • Holdsworth House Medical Practice

    Sydney, New South Wales, 2010

Other trials in Australia

Belgium5 sites

  • Dr. MARTINOT Jean-Benoît

    Erpent, 5101

  • UZ Gent

    Ghent, 9000

  • UZ Leuven Gasthuisberg

    Leuven, 3000

  • CHU de Liège

    Liège, 4000

  • VZW Emmaus

    Mechelen, 2800

Other trials in Belgium

Czechia5 sites

  • MUDr Otakar Hokynar - Plicni ambulance

    Kralupy nad Vltavou, 278 01

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

    Olomouc, 772 00

  • Dawon s.r.o.

    Prague, 14800

  • Plicní stredisko Teplice, s.r.o.

    Teplice, 415 01

  • MUDr. Milan Sklenar

    Varnsdorf, 407 47

Other trials in Czechia

Hungary5 sites

  • D.Kenessey A Hospital

    Balassagyarmat, 2660

  • EKBC, Uj Szent Janos Korhaz es Szakrendelo

    Budapest, 1122

  • Erzsebet Gondozohaz

    Gödöllő, 2100

  • Da Vinci Maganklinika

    Pécs, 7635

  • Farmakontroll Bt.

    Százhalombatta, 2440

Other trials in Hungary

Poland5 sites

  • Centrum Medycyny Oddechowej Mroz Spolka Jawna

    Bialystok, 15-044

  • KLIMED Marek Klimkiewicz

    Bychawa, 23-100

  • Centrum Alergologii Sp. z o.o.

    Lublin, 20-552

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

    Ostrowiec Świętokrzyski, 27-400

  • Centrum Medyczne Lucyna Andrzej Dymek

    Strzelce Opolskie, 47-100

Other trials in Poland

Slovakia5 sites

  • ALIAN s.r.o.

    Bardejov, 085 01

  • INSPIRO, s.r.o.

    Humenné, 066 01

  • AlergoImunocentrum, s.r.o.

    Kežmarok, 060 01

  • Plucna ambulancia s.r.o.

    Poprad, 058 01

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

    Topoľčany, 955 01

Other trials in Slovakia

Taiwan5 sites

  • Chang Gung Memorial Hospital Keelung

    Keelung, 20401

  • Far Eastern Memorial Hospital

    New Taipei City, 220

  • Taichung Veterans General Hospital

    Taichung, 40705

  • National Taiwan University Hospital

    Taipei, 100

  • Taipei Medical University Hospital

    Taipei, 110

Other trials in Taiwan

Turkey (Türkiye)5 sites

  • Akdeniz Universitesi Tip Fakultesi Hastanesi

    Antalya, 07058

  • Istanbul Universitesi Cerrahpasa-Cerrahpasa Tip Fakultesi

    Istanbul, 34098

  • Ege Universitesi Tip Fakultesi

    Izmir, 35100

  • Sureyyapasa Gogus Hasalikleri. ve Gogus Cerrahisi EAH

    Maltepe, 34844

  • Mersin Universitesi Tip Fakultesi

    Mersin, 33343

Other trials in Turkey (Türkiye)

United Kingdom5 sites

  • West Walk Surgery

    Bristol, BS37 4AX

  • Castle Hill Hospital

    Cottingham, HU16 5JQ

  • King's College Hospital - NHS Foundation Trust

    London, SE5 9RS

  • University Hospital of South Manchester

    Manchester, M23 9LT

  • North Tyneside General Hospital

    North Shields, Tyne and Wear, NE29 8NH

Other trials in United Kingdom

Italy4 sites

  • A.O.U. Careggi

    Florence, Tuscany, 50134

  • ASST Lodi

    Lodi, Lombardy, 26845

  • IRCCS Ospedale Sacro Cuore Don Calabria

    Verona, Veneto, 37024

  • A.O.U.I. Verona

    Verona, Veneto, 37126

Other trials in Italy

Spain3 sites

  • Hospital Universitari Germans Trias i Pujol

    Badalona, Barcelona, 08916

  • Hospital Clínic i Provincial de Barcelona

    Barcelona, 08036

  • Hospital Clínico Universitario de Santiago de Compostela

    Santiago de Compostela, A Coruña, 15706

Other trials in Spain

Canada2 sites

  • Burlington Lung Clinic (BLC) Clinical Research

    Burlington, Ontario, L7N 3V2

  • Clinique de pneumologie et du sommeil de Lanaudière (CPSL)

    Saint-Charles-Borromée, Quebec, J6E 2B4

Other trials in Canada

France2 sites

  • Cochin - Paris

    Paris, 75674

  • CHU de Toulouse - Hôpital Larrey

    Toulouse, 31059

Other trials in France

Netherlands2 sites

  • Catharina Ziekenhuis

    Eindhoven, North Brabant, 5623 EJ

  • Isala

    Zwolle, 8025 AB

Other trials in Netherlands

About this study

Official title: Randomized, Double-blind, Parallel Group, Phase 2b Dose-finding, Efficacy and Safety Study of 12-week Twice Daily Oral Administration of BAY 1817080 Compared to Placebo in the Treatment of Refractory and/or Unexplained Chronic Cough (RUCC)

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.

Being tested
BAY1817080, Placebo
Keywords
RUCC, Chronic cough, P2X3 receptor antagonist
Medical subject headings
Chronic Cough

What participants receive

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

  • BAY1817080Drug

    Study drug BAY1817080 will be administered orally as tablet.

  • PlaceboDrug

    Matching Placebo for BAY1817080 will be administered orally as tablet.

Study groups in NCT04562155
Study groupRoleWhat they receive
BAY1817080 dose A BIDExperimentalEach 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.
Receives: Drug: BAY1817080
BAY1817080 dose B BIDExperimentalEach 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.
Receives: Drug: BAY1817080
BAY1817080 dose C BIDExperimentalEach 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.
Receives: Drug: BAY1817080
PlaceboPlacebo comparatorEach 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.
Receives: Drug: Placebo

What is being measured

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

  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

    Measured: From baseline up to 12 weeks

Secondary outcomes (8)

  1. Percentage of Participants With a ≥30% Reduction 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. The change from baseline in 24-hour cough count was calculated by the geometric mean of 24-hour cough count after 12 weeks of intervention minus the geometric mean at baseline divided by the geometric mean at baseline. The percentage of participants with a reduction of ≥30% is shown

    Measured: From baseline up to 12 weeks

  2. Change From Baseline in 24-hour Cough Count After 2, 4, and 8 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 2, 4, and 8 weeks of intervention was divided by the geometric mean of 24-hour cough count at baseline.

    btw = between geo = geometric

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

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

    Measured by cough recording digital wearable monitoring device

    btw = between geo = geometric

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

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

    Measured by Leicester Cough Questionnaire (LCQ) total score. The LCQ was a 19-item instrument that asked about the impact of chronic cough on various aspects of participants' lives using a recall period of two weeks. The 8 items: 1, 2, 3, 9, 10, 11, 14, 15 built the physical domain. 7 items: 4, 5, 6, 12, 13, 16, 17 built the psychological domain. Further 4 items: 7, 8, 18 and 19 built the social domain. Study participants responded to the items using a 7-point Likert scale from 1 (all of the time) to 7 (none of the time) and entered their assessments on a tablet device. Completion of the LCQ took approximately five minutes. The LCQ total score was calculated as a mean score for each of the three domains ranging from 1 to 7, with the LCQ total score ranging from 3 to 21.

    Measured: From baseline up to 12 weeks

  5. Change From Baseline in Cough Severity After 12 Weeks of Intervention

    Measured by Cough Severity Visual Analogue Scale (VAS). The Cough Severity VAS was a single item instrument, asking the study participant to assess the severity of his/her cough using a 0-100 VAS.

    This was a vertically oriented line ordered from 0-100, with 0 = "No Cough" and 100 = "Extremely Severe Cough".

    Measured: From baseline up to 12 weeks

  6. Percentage of Participants With a ≥30 Scale Units Reduction From Baseline After 12 Weeks of Intervention

    Measured by cough Severity VAS

    Measured: From baseline up to 12 weeks

  7. Percentage of Participants With a ≥1.3-point Increase From Baseline After 12 Weeks of Intervention

    Measured by LCQ total score. The LCQ was a 19-item instrument that asked about the impact of chronic cough on various aspects of participants' lives using a recall period of two weeks. The 8 items: 1, 2, 3, 9, 10, 11, 14, 15 built the physical domain. 7 items: 4, 5, 6, 12, 13, 16, 17 built the psychological domain. Further 4 items: 7, 8, 18 and 19 built the social domain. Study participants responded to the items using a 7-point Likert scale from 1 (all of the time) to 7 (none of the time) and entered their assessments on a tablet device. Completion of the LCQ took approximately five minutes. The LCQ total score was calculated as a mean score for each of the three domains ranging from 1 to 7, with the LCQ total score ranging from 3 to 21. The percentage of participants with a >= 1.3-point increase in LCQ total score is shown.

    Measured: From baseline up to 12 weeks

  8. Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Associated Severity

    Adverse event (AE) was defined as any untoward medical occurrence in a study participant, whether or not considered related to the study intervention, occurring from the time of signing the informed consent until the follow-up visit.

    TEAE was defined as any event occurring or worsening after the start of study intervention administration until 14 days after the last intake of study intervention.

    Measured: From the start of study intervention administration until 14 days after the last study medication intake, with an average of 80.0 + 14 days

Timeline

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

  1. First posted24 Sep 2020
  2. Study start2 Oct 2020
  3. Primary completion22 Jun 2021
  4. Study completion23 Jul 2021

Resources

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
Double blind
Who is masked
Participant, Investigator
Enrolment
310 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04562155
Sponsor's protocol ID
20393
Other IDs
2019-004169-42, 2019
Acronym
PAGANINI
Status last verified
Jul 2022
First submitted
18 Sep 2020
Last updated
18 Aug 2022
Data monitoring committee
No
FDA-regulated drug
Yes
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.

Publications

  • 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.

    PubMed 34978027

  • 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.

    PubMed 40498172

  • 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.

    PubMed 37261531

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing BAY1817080 in people with Refractory and/or Unexplained Chronic Cough, run by Bayer at 99 sites in 19 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 5 inclusion and 6 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 18 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 99 sites in Japan, United States, Argentina, Germany, Russia and 14 more countries. 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?

Yes. Results are posted in the registry (first posted 18 Aug 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Change From Baseline in 24-hour Cough Count After 12 Weeks of Intervention (time frame: From baseline up to 12 weeks). 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 NCT04562155, which also lists 3 linked publications.

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 18 Aug 2022.

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