check_circleStudy Completed
Refractory and/or unexplained chronic cough
Bayer Identifier:
20393
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
Clinical study to evaluate the efficacy and safety of three different doses of BAY1817080 compared to placebo in patients with chronic cough
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.
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.
Key Participants Requirements
Sex
AllAge
18 - N/ATrial summary
Enrollment Goal
310Trial Dates
October 2020 - July 2021Phase
Phase 2Could I Receive a placebo
YesProducts
Eliapixant (BAY1817080)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Akdeniz Universitesi Tip Fakultesi Hastanesi | Antalya, 07058, Turkey |
Completed | UZ Leuven Gasthuisberg | LEUVEN, 3000, Belgium |
Completed | UZ Gent | GENT, 9000, Belgium |
Completed | Dr. MARTINOT Jean-Benoît | Erpent, 5101, Belgium |
Completed | CHU de Liège | LIEGE, 4000, Belgium |
Completed | Sureyyapasa Gogus Hasalikleri. ve Gogus Cerrahisi EAH | Maltepe, 34844, Turkey |
Completed | Hospital Universitari Germans Trias i Pujol | Badalona, 08916, Spain |
Withdrawn | Hospital de la Santa Creu i de Sant Pau | Barcelona, 08041, Spain |
Withdrawn | Hospital Universitari i Politècnic La Fe | Valencia, 46026, Spain |
Completed | Mersin Universitesi Tip Fakultesi | Mersin, 33343, Turkey |
Completed | Istanbul Universitesi Cerrahpasa-Cerrahpasa Tip Fakultesi | Istanbul, 34098, Turkey |
Completed | Voronezh Regional Clinical Hospital #1 | Voronezh, 394066, Russian Federation |
Completed | City Consultative and Diagnostic Center #1 | St. Petersburg, 194354, Russian Federation |
Completed | City Clinical Hospital #4 Samara | Samara, 453056, Russian Federation |
Completed | City Clinical Hospital n.a. D.D. Pletnev | Moscow, 105077, Russian Federation |
Completed | LLC "Medical Center "SibNovoMed"" | Novosibirsk, 630005, Russian Federation |
Withdrawn | City Clinical Hospital #3 | Chelyabinsk, 454021, Russian Federation |
Completed | LLC Astarta | St. Petersburg, 199226, Russian Federation |
Completed | Region Clinical Emergency Hospital n.a. M.A.Podgorbunskogo | Kemerovo, 650000, Russian Federation |
Completed | VZW Emmaus | MECHELEN, 2800, Belgium |
Completed | Hospital Clínico Universitario de Santiago de Compostela | Santiago de Compostela, 15706, Spain |
Completed | Fundación CIDEA | CABA, C1121ABE, Argentina |
Completed | Investigaciones en Patologías Respiratorias | San Miguel de Tucumán, Argentina |
Completed | Investigación en Alergias y Enfermedades Respiratorias-INAER | CABA, C1425, Argentina |
Completed | Centro Médico Dra. De Salvo - Clinical Research Center | Buenos Aires, C1426ABP, Argentina |
Completed | Instituto Ave Pulmo | Mar del Plata, Argentina |
Completed | Centro Respiratorio Quilmes | Quilmes, Argentina |
Completed | Centro de Investigaciones Clínicas | CABA, C1018DES, Argentina |
Withdrawn | Ataturk Universitesi Tip Fakultesi | Erzurum, 25240, Turkey |
Withdrawn | Ankara Sehir Hastanesi | Ankara, 06800, Turkey |
Withdrawn | Izmir Dr. Suat Seren Gogus Hastaliklari Ve Cerrahisi EAH | Izmir, 35170, Turkey |
Completed | Chesapeake Clinical Research, Inc. | White Marsh, 21162, United States |
Withdrawn | American Health Research | Charlotte, 28277, United States |
Completed | Pharmaceutical Research & Consulting, Inc. | Dallas, 75231, United States |
Completed | California Allergy & Asthma Medical Group & Research Center | Los Angeles, 90025, United States |
Completed | Bellingham Asthma, Allergy & Immunology Clinic | Bellingham, 98225, United States |
Completed | Montana Medical Research, Inc | Missoula, 59808, United States |
Completed | Minnesota Lung Center | Edina, 55435, United States |
Completed | Hospital Clínic i Provincial de Barcelona | Barcelona, 08036, Spain |
Completed | Ege Universitesi Tip Fakultesi | Izmir, 35100, Turkey |
Withdrawn | Noord West Ziekenhuisgroep-Medisch Centrum Alkmaar | ALKMAAR, 1815 JD, Netherlands |
Withdrawn | Hospital Rey Juan Carlos | Móstoles, 28933, Spain |
Withdrawn | Hospital Arnau de Vilanova de Valencia | Valencia, 46015, Spain |
Completed | A.O.U.I. Verona | Verona, 37126, Italy |
Completed | A.O.U. Careggi | Firenze, 50134, Italy |
Completed | ASST Lodi | Lodi, 26845, Italy |
Completed | IRCCS Ospedale Sacro Cuore Don Calabria | Verona, 37024, Italy |
Withdrawn | IRCCS Ospedale Policlinico San Martino | Genova, 16132, Italy |
Completed | Medizinische Hochschule Hannover (MHH) | Hannover, 30625, Germany |
Completed | Ballenberger, Freytag, Wenisch | Neu-Isenburg, 63263, Germany |
Completed | Pneumologicum im Südstadt Forum | Hannover, 30173, Germany |
Withdrawn | Universitätsklinikum des Saarlandes | Homburg, 66421, Germany |
Completed | Praxis f. Lungen- und Bronchialheilkunde, | Berlin, 10717, Germany |
Completed | Priv.-Doz. Dr. med. Christian Gessner | Leipzig, 04357, Germany |
Withdrawn | Städt. Krankenhaus Martha-Maria Halle-Dölau gGmbH | Halle, 06120, Germany |
Completed | Zentrum f. ambulante pneumologische Forschung Marburg GbR | Marburg, 35037, Germany |
Completed | Klinikum Konstanz | Konstanz, 78464, Germany |
Withdrawn | Medizinische Fakultät der Otto-von-Guericke Universität | Magdeburg, 39112, Germany |
Completed | Isala | ZWOLLE, 8025 AB, Netherlands |
Completed | Catharina Ziekenhuis | EINDHOVEN, 5623 EJ, Netherlands |
Withdrawn | Clinical Research Institute | Minneapolis, 55402, United States |
Completed | Dawon s.r.o. | Praha 4, 14800, Czechia |
Completed | Ordinace pro TBC a respiracni nemoci, s.r.o. | Olomouc, 772 00, Czechia |
Completed | Plicní stredisko Teplice, s.r.o. | Teplice, 415 01, Czechia |
Completed | MUDr Otakar Hokynar - Plicni ambulance | Kralupy nad Vltavou, 278 01, Czechia |
Completed | MUDr. Milan Sklenar | Varnsdorf, 407 47, Czechia |
Completed | National Taiwan University Hospital | Taipei, 100, Taiwan |
Completed | Chang Gung Memorial Hospital Keelung | Keelung, 20401, Taiwan |
Completed | Taichung Veterans General Hospital | Taichung, 40705, Taiwan |
Completed | Taipei Medical University Hospital | Taipei, 110, Taiwan |
Completed | Far Eastern Memorial Hospital | New Taipei City, 220, Taiwan |
Completed | Ostrowieckie Centrum Medyczne Sp. Cyw. A.O-C. K.C. | Ostrowiec Swietokrzyski, 27-400, Poland |
Completed | KLIMED Marek Klimkiewicz | Bychawa, 23-100, Poland |
Completed | Centrum Alergologii Sp. z o.o. | Lublin, 20-552, Poland |
Completed | Centrum Medyczne Lucyna Andrzej Dymek | Strzelce Opolskie, 47-100, Poland |
Completed | Centrum Medycyny Oddechowej Mroz Spolka Jawna | Bialystok, 15-044, Poland |
Completed | Castle Hill Hospital | Cottingham, HU16 5JQ, United Kingdom |
Completed | King's College Hospital - NHS Foundation Trust | London, SE5 9RS, United Kingdom |
Completed | University Hospital of South Manchester | Manchester, M23 9LT, United Kingdom |
Completed | North Tyneside General Hospital | North Shields, NE29 8NH, United Kingdom |
Withdrawn | Queen's University | Belfast, BT9 7AB, United Kingdom |
Withdrawn | Oxford University Hospitals | Oxford, OX9 3DU, United Kingdom |
Completed | West Walk Surgery | Bristol, BS37 4AX, United Kingdom |
Completed | Vanderbilt University Medical School | Nashville, 37212-1610, United States |
Completed | CHU de Toulouse - Hôpital Larrey | TOULOUSE Cedex 9, 31059, France |
Completed | Cochin - Paris | PARIS, 75674, France |
Withdrawn | ASST Fatebenefratelli Sacco | Milano, 20157, Italy |
Withdrawn | University of Calgary | Calgary, T2N 4Z6, Canada |
Withdrawn | McMaster University | Hamilton, L8N 3Z5, Canada |
Completed | Burlington Lung Clinic (BLC) Clinical Research | Burlington, L7N 3V2, Canada |
Withdrawn | Inspiration Research Limited | Toronto, M5T 3A9, Canada |
Completed | Clinique de pneumologie et du sommeil de Lanaudière (CPSL) | St-Charles-Borromée, J6E 2B4, Canada |
Completed | Western Respiratory Trial Specialists | Spearwood, 6163, Australia |
Completed | Holdsworth House Medical Practice | Sydney, 2010, Australia |
Withdrawn | John Hunter Hospital | New Lambton Heights, 2305, Australia |
Completed | Maroubra Medical Centre | Maroubra, 2035, Australia |
Completed | Macquarie University Hospital | Macquarie University, 2109, Australia |
Completed | Royal Adelaide Hospital | Adelaide, 5000, Australia |
Completed | D.Kenessey A Hospital | Balassagyarmat, 2660, Hungary |
Completed | Erzsebet Gondozohaz | Godollo, 2100, Hungary |
Completed | Da Vinci Maganklinika | Pecs, 7635, Hungary |
Completed | Farmakontroll Bt. | Szazhalombatta, 2440, Hungary |
Completed | EKBC, Uj Szent Janos Korhaz es Szakrendelo | Budapest, 1122, Hungary |
Completed | Plucna ambulancia s.r.o. | Poprad, 058 01, Slovakia |
Completed | AlergoImunocentrum, s.r.o. | Kezmarok, 060 01, Slovakia |
Withdrawn | Pneumoftizeo, s.r.o. | Poprad, 058 01, Slovakia |
Completed | INSPIRO, s.r.o. | Humenne, 066 01, Slovakia |
Completed | ALIAN s.r.o. | Bardejov, 085 01, Slovakia |
Completed | Ambulancia klin. imunologie a alergologie, ANA JJ, s.r.o. | Topolcany, 955 01, Slovakia |
Completed | Nagoya City University Hospital | Nagoya, 467-8602, Japan |
Completed | Japan community health care organization Kanazawa Hospital | Kanazawa, 920-8610, Japan |
Completed | Idaimae Minami Yojo | Sapporo, 064-0804, Japan |
Withdrawn | Kobe City Medical Center West Hospital | Kobe, 653-0013, Japan |
Completed | Matsusaka Municipal Hospital | Matsusaka, 515-8544, Japan |
Completed | Komatsu Municipal Hospital | Komatsu, 923-8560, Japan |
Completed | University of Occupational and Environmental Health | Kitakyushu, 807-8556, Japan |
Completed | Saiseikai Yokohamashi Nanbu Hospital | Yokohama, 234-8503, Japan |
Completed | Yokohama City Minato Red Cross Hospital | Yokohama, 231-8682, Japan |
Completed | Fukushima Medical University Hospital | Fukushima, 960-1295, Japan |
Completed | Hamamatsu Rosai Hospital | Hamamatsu, 430-8525, Japan |
Withdrawn | Kanagawa Cardiovascular and Respiratory Center | Yokohama, 236-0051, Japan |
Completed | Tokyo Shinagawa Hospital | Shinagawa-ku, 140-8522, Japan |
Completed | University of Fukui Hospital | Yoshida, 910-1193, Japan |
Completed | Florida Pediatrics | Largo, 33778, United States |
Withdrawn | Osaka Saiseikai Nakatsu Hospital | Osaka, 530-0012, Japan |
Withdrawn | National Hospital Organization Kanazawa Medical Center | Kanazawa, 920-8650, Japan |
Withdrawn | Sagamihara National Hospital | Sagamihara, 252-0392, Japan |
Primary Outcome
- Change from baseline in 24-hour cough count after 12 weeks of interventionMeasured by cough recording digital wearable monitoring device. btw = between geo = geometric Per protocol set (PPS): All participants randomly assigned to study intervention who did not have validity findings affecting efficacy. Participants were analyzed according to the intervention they actually received. If a participant received different interventions during the study, he/she was excluded from the PPS. The main reasons for excluding the participants from the PPS were that there was no valid post-baseline measurement available due to an intercurrent event (15 participants , 4.8%) or that the participant had used prohibited concomitant medication (9 participants , 2.9%).date_rangeTime Frame:From baseline up to 12 weeks
Secondary Outcome
- Percentage of participants with a ≥30% reduction from baseline in 24-hour cough count after 12 weeks of interventionMeasured by cough recording digital wearable monitoring device PPS: All participants randomly assigned to study intervention who did not have validity findings affecting efficacy. Participants were analyzed according to the intervention they actually received. If a participant received different interventions during the study, he/she was excluded from the PPS. The main reasons for excluding the participants from the PPS were that there was no valid post-baseline measurement available due to an intercurrent event (15 participants , 4.8%) or that the participant had used prohibited concomitant medication (9 participants , 2.9%).date_rangeTime Frame:From baseline up to 12 weeks
- Change from baseline in 24-hour cough count after 2, 4, and 8 weeks of interventionMeasured by cough recording digital wearable monitoring device btw = between geo = geometric PPS: All participants randomly assigned to study intervention who did not have validity findings affecting efficacy. Participants were analyzed according to the intervention they actually received. If a participant received different interventions during the study, he/she was excluded from the PPS. The main reasons for excluding the participants from the PPS were that there was no valid post-baseline measurement available due to an intercurrent event (15 participants , 4.8%) or that the participant had used prohibited concomitant medication (9 participants , 2.9%).date_rangeTime Frame: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 interventionMeasured by cough recording digital wearable monitoring device btw = between geo = geometric PPS: All participants randomly assigned to study intervention who did not have validity findings affecting efficacy. Participants were analyzed according to the intervention they actually received. If a participant received different interventions during the study, he/she was excluded from the PPS. The main reasons for excluding the participants from the PPS were that there was no valid post-baseline measurement available due to an intercurrent event (15 participants , 4.8%) or that the participant had used prohibited concomitant medication (9 participants , 2.9%).date_rangeTime Frame: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 interventionMeasured by Leicester Cough Questionnaire [LCQ] PPS: All participants randomly assigned to study intervention who did not have validity findings affecting efficacy. Participants were analyzed according to the intervention they actually received. If a participant received different interventions during the study, he/she was excluded from the PPS. The main reasons for excluding the participants from the PPS were that there was no valid post-baseline measurement available due to an intercurrent event (15 participants , 4.8%) or that the participant had used prohibited concomitant medication (9 participants , 2.9%).date_rangeTime Frame:From baseline up to 12 weeks
- Change from baseline in cough severity after 12 weeks of interventionMeasured by Cough Severity Visual Analogue Scale [VAS] PPS: All participants randomly assigned to study intervention who did not have validity findings affecting efficacy. Participants were analyzed according to the intervention they actually received. If a participant received different interventions during the study, he/she was excluded from the PPS. The main reasons for excluding the participants from the PPS were that there was no valid post-baseline measurement available due to an intercurrent event (15 participants , 4.8%) or that the participant had used prohibited concomitant medication (9 participants , 2.9%).date_rangeTime Frame:From baseline up to 12 weeks
- Percentage of participants with a ≥30 scale units reduction from baseline after 12 weeks of interventionMeasured by cough Severity VAS PPS: All participants randomly assigned to study intervention who did not have validity findings affecting efficacy. Participants were analyzed according to the intervention they actually received. If a participant received different interventions during the study, he/she was excluded from the PPS. The main reasons for excluding the participants from the PPS were that there was no valid post-baseline measurement available due to an intercurrent event (15 participants , 4.8%) or that the participant had used prohibited concomitant medication (9 participants , 2.9%).date_rangeTime Frame:From baseline up to 12 weeks
- Percentage of participants with a ≥1.3-point increase from baseline after 12 weeks of interventionMeasured with LCQ Total Score PPS: All participants randomly assigned to study intervention who did not have validity findings affecting efficacy. Participants were analyzed according to the intervention they actually received. If a participant received different interventions during the study, he/she was excluded from the PPS. The main reasons for excluding the participants from the PPS were that there was no valid post-baseline measurement available due to an intercurrent event (15 participants , 4.8%) or that the participant had used prohibited concomitant medication (9 participants , 2.9%).date_rangeTime Frame:From baseline up to 12 weeks
- Number of participants with treatment-emergent adverse events (TEAEs) and associated severitySafety analysis set (SAF): All participants randomly assigned to study intervention and who took at least one tablet of study intervention. Subjects were analyzed according to the intervention they actually received.date_rangeTime Frame:From the start of study intervention administration until 14 days after the last study medication intake
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
RandomizedBlinding
N/AAssignment
Parallel AssignmentTrial Arms
4