Trial Condition(s):

Refractory and/or unexplained chronic cough

Clinical study to evaluate the efficacy and safety of three different doses of BAY1817080 compared to placebo in patients with chronic cough (PAGANINI)

Bayer Identifier:

20393

ClinicalTrials.gov Identifier:

NCT04562155

EudraCT Number:

2019-004169-42

Study Completed

Trial Purpose

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.

Inclusion Criteria
- 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.
Exclusion Criteria
- 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 Summary

Enrollment Goal
310
Trial Dates
black-arrow
Phase
2
Could I receive a placebo?
Yes
Products
Eliapixant (BAY1817080)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Akdeniz Universitesi Tip Fakultesi Hastanesi

Antalya, Turkey, 07058

Status
Completed
 
Locations

UZ Leuven Gasthuisberg

LEUVEN, Belgium, 3000

Status
Completed
 
Locations

UZ Gent

GENT, Belgium, 9000

Status
Completed
 
Locations

Dr. MARTINOT Jean-Benoît

Erpent, Belgium, 5101

Status
Completed
 
Locations

CHU de Liège

LIEGE, Belgium, 4000

Status
Completed
 
Locations

Sureyyapasa Gogus Hasalikleri. ve Gogus Cerrahisi EAH

Maltepe, Turkey, 34844

Status
Completed
 
Locations

Hospital Universitari Germans Trias i Pujol

Badalona, Spain, 08916

Status
Completed
 
Locations

Mersin Universitesi Tip Fakultesi

Mersin, Turkey, 33343

Status
Completed
 
Locations

Istanbul Universitesi Cerrahpasa-Cerrahpasa Tip Fakultesi

Istanbul, Turkey, 34098

Status
Completed
 
Locations

Voronezh Regional Clinical Hospital #1

Voronezh, Russia, 394066

Status
Completed
 
Locations

City Consultative and Diagnostic Center #1

St. Petersburg, Russia, 194354

Status
Completed
 
Locations

City Clinical Hospital #4 Samara

Samara, Russia, 453056

Status
Completed
 
Locations

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

Moscow, Russia, 105077

Status
Completed
 
Locations

LLC "Medical Center "SibNovoMed""

Novosibirsk, Russia, 630005

Status
Completed
 
Locations

LLC Astarta

St. Petersburg, Russia, 199226

Status
Completed
 
Locations

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

Kemerovo, Russia, 650000

Status
Completed
 
Locations

VZW Emmaus

MECHELEN, Belgium, 2800

Status
Completed
 
Locations

Hospital Clínico Universitario de Santiago de Compostela

Santiago de Compostela, Spain, 15706

Status
Completed
 
Locations

Fundación CIDEA

CABA, Argentina, C1121ABE

Status
Completed
 
Locations

Investigaciones en Patologías Respiratorias

San Miguel de Tucumán, Argentina

Status
Completed
 
Locations

Investigación en Alergias y Enfermedades Respiratorias-INAER

CABA, Argentina, C1425

Status
Completed
 
Locations

Centro Médico Dra. De Salvo - Clinical Research Center

Buenos Aires, Argentina, C1426ABP

Status
Completed
 
Locations

Instituto Ave Pulmo

Mar del Plata, Argentina

Status
Completed
 
Locations

Centro Respiratorio Quilmes

Quilmes, Argentina

Status
Completed
 
Locations

Centro de Investigaciones Clínicas

CABA, Argentina, C1018DES

Status
Completed
 
Locations

Chesapeake Clinical Research, Inc.

White Marsh, United States, 21162

Status
Completed
 
Locations

Pharmaceutical Research & Consulting, Inc.

Dallas, United States, 75231

Status
Completed
 
Locations

California Allergy & Asthma Medical Group & Research Center

Los Angeles, United States, 90025

Status
Completed
 
Locations

Bellingham Asthma, Allergy & Immunology Clinic

Bellingham, United States, 98225

Status
Completed
 
Locations

Montana Medical Research, Inc

Missoula, United States, 59808

Status
Completed
 
Locations

Minnesota Lung Center

Edina, United States, 55435

Status
Completed
 
Locations

Hospital Clínic i Provincial de Barcelona

Barcelona, Spain, 08036

Status
Completed
 
Locations

Ege Universitesi Tip Fakultesi

Izmir, Turkey, 35100

Status
Completed
 
Locations

A.O.U.I. Verona

Verona, Italy, 37126

Status
Completed
 
Locations

A.O.U. Careggi

Firenze, Italy, 50134

Status
Completed
 
Locations

ASST Lodi

Lodi, Italy, 26845

Status
Completed
 
Locations

IRCCS Ospedale Sacro Cuore Don Calabria

Verona, Italy, 37024

Status
Completed
 
Locations

Medizinische Hochschule Hannover (MHH)

Hannover, Germany, 30625

Status
Completed
 
Locations

Ballenberger, Freytag, Wenisch

Neu-Isenburg, Germany, 63263

Status
Completed
 
Locations

Pneumologicum im Südstadt Forum

Hannover, Germany, 30173

Status
Completed
 
Locations

Praxis f. Lungen- und Bronchialheilkunde,

Berlin, Germany, 10717

Status
Completed
 
Locations

Priv.-Doz. Dr. med. Christian Gessner

Leipzig, Germany, 04357

Status
Completed
 
Locations

Zentrum f. ambulante pneumologische Forschung Marburg GbR

Marburg, Germany, 35037

Status
Completed
 
Locations

Klinikum Konstanz

Konstanz, Germany, 78464

Status
Completed
 
Locations

Isala

ZWOLLE, Netherlands, 8025 AB

Status
Completed
 
Locations

Catharina Ziekenhuis

EINDHOVEN, Netherlands, 5623 EJ

Status
Completed
 
Locations

Dawon s.r.o.

Praha 4, Czech Republic, 14800

Status
Completed
 
Locations

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

Olomouc, Czech Republic, 772 00

Status
Completed
 
Locations

Plicní stredisko Teplice, s.r.o.

Teplice, Czech Republic, 415 01

Status
Completed
 
Locations

MUDr Otakar Hokynar - Plicni ambulance

Kralupy nad Vltavou, Czech Republic, 278 01

Status
Completed
 
Locations

MUDr. Milan Sklenar

Varnsdorf, Czech Republic, 407 47

Status
Completed
 
Locations

National Taiwan University Hospital

Taipei, Taiwan, China, 100

Status
Completed
 
Locations

Chang Gung Memorial Hospital Keelung

Keelung, Taiwan, China, 20401

Status
Completed
 
Locations

Taichung Veterans General Hospital

Taichung, Taiwan, China, 40705

Status
Completed
 
Locations

Taipei Medical University Hospital

Taipei, Taiwan, China, 110

Status
Completed
 
Locations

Far Eastern Memorial Hospital

New Taipei City, Taiwan, China, 220

Status
Completed
 
Locations

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

Ostrowiec Swietokrzyski, Poland, 27-400

Status
Completed
 
Locations

KLIMED Marek Klimkiewicz

Bychawa, Poland, 23-100

Status
Completed
 
Locations

Centrum Alergologii Sp. z o.o.

Lublin, Poland, 20-552

Status
Completed
 
Locations

Centrum Medyczne Lucyna Andrzej Dymek

Strzelce Opolskie, Poland, 47-100

Status
Completed
 
Locations

Centrum Medycyny Oddechowej Mroz Spolka Jawna

Bialystok, Poland, 15-044

Status
Completed
 
Locations

Castle Hill Hospital

Cottingham, United Kingdom, HU16 5JQ

Status
Completed
 
Locations

King's College Hospital - NHS Foundation Trust

London, United Kingdom, SE5 9RS

Status
Completed
 
Locations

University Hospital of South Manchester

Manchester, United Kingdom, M23 9LT

Status
Completed
 
Locations

North Tyneside General Hospital

North Shields, United Kingdom, NE29 8NH

Status
Completed
 
Locations

West Walk Surgery

Bristol, United Kingdom, BS37 4AX

Status
Completed
 
Locations

Vanderbilt University Medical School

Nashville, United States, 37212-1610

Status
Completed
 
Locations

CHU de Toulouse - Hôpital Larrey

TOULOUSE Cedex 9, France, 31059

Status
Completed
 
Locations

Cochin - Paris

PARIS, France, 75674

Status
Completed
 
Locations

Burlington Lung Clinic (BLC) Clinical Research

Burlington, Canada, L7N 3V2

Status
Completed
 
Locations

Clinique de pneumologie et du sommeil de Lanaudière (CPSL)

St-Charles-Borromée, Canada, J6E 2B4

Status
Completed
 
Locations

Western Respiratory Trial Specialists

Spearwood, Australia, 6163

Status
Completed
 
Locations

Holdsworth House Medical Practice

Sydney, Australia, 2010

Status
Completed
 
Locations

Maroubra Medical Centre

Maroubra, Australia, 2035

Status
Completed
 
Locations

Macquarie University Hospital

Macquarie University, Australia, 2109

Status
Completed
 
Locations

Royal Adelaide Hospital

Adelaide, Australia, 5000

Status
Completed
 
Locations

D.Kenessey A Hospital

Balassagyarmat, Hungary, 2660

Status
Completed
 
Locations

Erzsebet Gondozohaz

Godollo, Hungary, 2100

Status
Completed
 
Locations

Da Vinci Maganklinika

Pecs, Hungary, 7635

Status
Completed
 
Locations

Farmakontroll Bt.

Szazhalombatta, Hungary, 2440

Status
Completed
 
Locations

EKBC, Uj Szent Janos Korhaz es Szakrendelo

Budapest, Hungary, 1122

Status
Completed
 
Locations

Plucna ambulancia s.r.o.

Poprad, Slovakia, 058 01

Status
Completed
 
Locations

AlergoImunocentrum, s.r.o.

Kezmarok, Slovakia, 060 01

Status
Completed
 
Locations

INSPIRO, s.r.o.

Humenne, Slovakia, 066 01

Status
Completed
 
Locations

ALIAN s.r.o.

Bardejov, Slovakia, 085 01

Status
Completed
 
Locations

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

Topolcany, Slovakia, 955 01

Status
Completed
 
Locations

Nagoya City University Hospital

Nagoya, Japan, 467-8602

Status
Completed
 
Locations

Japan community health care organization Kanazawa Hospital

Kanazawa, Japan, 920-8610

Status
Completed
 
Locations

Idaimae Minami Yojo

Sapporo, Japan, 064-0804

Status
Completed
 
Locations

Matsusaka Municipal Hospital

Matsusaka, Japan, 515-8544

Status
Completed
 
Locations

Komatsu Municipal Hospital

Komatsu, Japan, 923-8560

Status
Completed
 
Locations

University of Occupational and Environmental Health

Kitakyushu, Japan, 807-8556

Status
Completed
 
Locations

Saiseikai Yokohamashi Nanbu Hospital

Yokohama, Japan, 234-8503

Status
Completed
 
Locations

Yokohama City Minato Red Cross Hospital

Yokohama, Japan, 231-8682

Status
Completed
 
Locations

Fukushima Medical University Hospital

Fukushima, Japan, 960-1295

Status
Completed
 
Locations

Hamamatsu Rosai Hospital

Hamamatsu, Japan, 430-8525

Status
Completed
 
Locations

Tokyo Shinagawa Hospital

Shinagawa-ku, Japan, 140-8522

Status
Completed
 
Locations

University of Fukui Hospital

Yoshida, Japan, 910-1193

Status
Completed
 
Locations

Florida Pediatrics

Largo, United States, 33778

Status
Completed
 

Trial Design