check_circleStudy Completed

Refractory and/or unexplained chronic cough

Bayer Identifier:

20393

ClinicalTrials.gov Identifier:

NCT04562155

EudraCT Number:

2019-004169-42

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.

Key Participants Requirements

Sex

All

Age

18 - N/A
  • - 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.
  • - 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
October 2020 - July 2021
Phase
Phase 2
Could I Receive a placebo
Yes
Products
Eliapixant (BAY1817080)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Akdeniz Universitesi Tip Fakultesi HastanesiAntalya, 07058, Turkey
Completed
UZ Leuven GasthuisbergLEUVEN, 3000, Belgium
Completed
UZ GentGENT, 9000, Belgium
Completed
Dr. MARTINOT Jean-BenoîtErpent, 5101, Belgium
Completed
CHU de LiègeLIEGE, 4000, Belgium
Completed
Sureyyapasa Gogus Hasalikleri. ve Gogus Cerrahisi EAHMaltepe, 34844, Turkey
Completed
Hospital Universitari Germans Trias i PujolBadalona, 08916, Spain
Withdrawn
Hospital de la Santa Creu i de Sant PauBarcelona, 08041, Spain
Withdrawn
Hospital Universitari i Politècnic La FeValencia, 46026, Spain
Completed
Mersin Universitesi Tip FakultesiMersin, 33343, Turkey
Completed
Istanbul Universitesi Cerrahpasa-Cerrahpasa Tip FakultesiIstanbul, 34098, Turkey
Completed
Voronezh Regional Clinical Hospital #1Voronezh, 394066, Russian Federation
Completed
City Consultative and Diagnostic Center #1St. Petersburg, 194354, Russian Federation
Completed
City Clinical Hospital #4 SamaraSamara, 453056, Russian Federation
Completed
City Clinical Hospital n.a. D.D. PletnevMoscow, 105077, Russian Federation
Completed
LLC "Medical Center "SibNovoMed""Novosibirsk, 630005, Russian Federation
Withdrawn
City Clinical Hospital #3Chelyabinsk, 454021, Russian Federation
Completed
LLC AstartaSt. Petersburg, 199226, Russian Federation
Completed
Region Clinical Emergency Hospital n.a. M.A.PodgorbunskogoKemerovo, 650000, Russian Federation
Completed
VZW EmmausMECHELEN, 2800, Belgium
Completed
Hospital Clínico Universitario de Santiago de CompostelaSantiago de Compostela, 15706, Spain
Completed
Fundación CIDEACABA, C1121ABE, Argentina
Completed
Investigaciones en Patologías RespiratoriasSan Miguel de Tucumán, Argentina
Completed
Investigación en Alergias y Enfermedades Respiratorias-INAERCABA, C1425, Argentina
Completed
Centro Médico Dra. De Salvo - Clinical Research CenterBuenos Aires, C1426ABP, Argentina
Completed
Instituto Ave PulmoMar del Plata, Argentina
Completed
Centro Respiratorio QuilmesQuilmes, Argentina
Completed
Centro de Investigaciones ClínicasCABA, C1018DES, Argentina
Withdrawn
Ataturk Universitesi Tip FakultesiErzurum, 25240, Turkey
Withdrawn
Ankara Sehir HastanesiAnkara, 06800, Turkey
Withdrawn
Izmir Dr. Suat Seren Gogus Hastaliklari Ve Cerrahisi EAHIzmir, 35170, Turkey
Completed
Chesapeake Clinical Research, Inc.White Marsh, 21162, United States
Withdrawn
American Health ResearchCharlotte, 28277, United States
Completed
Pharmaceutical Research & Consulting, Inc.Dallas, 75231, United States
Completed
California Allergy & Asthma Medical Group & Research CenterLos Angeles, 90025, United States
Completed
Bellingham Asthma, Allergy & Immunology ClinicBellingham, 98225, United States
Completed
Montana Medical Research, IncMissoula, 59808, United States
Completed
Minnesota Lung CenterEdina, 55435, United States
Completed
Hospital Clínic i Provincial de BarcelonaBarcelona, 08036, Spain
Completed
Ege Universitesi Tip FakultesiIzmir, 35100, Turkey
Withdrawn
Noord West Ziekenhuisgroep-Medisch Centrum AlkmaarALKMAAR, 1815 JD, Netherlands
Withdrawn
Hospital Rey Juan CarlosMóstoles, 28933, Spain
Withdrawn
Hospital Arnau de Vilanova de ValenciaValencia, 46015, Spain
Completed
A.O.U.I. VeronaVerona, 37126, Italy
Completed
A.O.U. CareggiFirenze, 50134, Italy
Completed
ASST LodiLodi, 26845, Italy
Completed
IRCCS Ospedale Sacro Cuore Don CalabriaVerona, 37024, Italy
Withdrawn
IRCCS Ospedale Policlinico San MartinoGenova, 16132, Italy
Completed
Medizinische Hochschule Hannover (MHH)Hannover, 30625, Germany
Completed
Ballenberger, Freytag, WenischNeu-Isenburg, 63263, Germany
Completed
Pneumologicum im Südstadt ForumHannover, 30173, Germany
Withdrawn
Universitätsklinikum des SaarlandesHomburg, 66421, Germany
Completed
Praxis f. Lungen- und Bronchialheilkunde,Berlin, 10717, Germany
Completed
Priv.-Doz. Dr. med. Christian GessnerLeipzig, 04357, Germany
Withdrawn
Städt. Krankenhaus Martha-Maria Halle-Dölau gGmbHHalle, 06120, Germany
Completed
Zentrum f. ambulante pneumologische Forschung Marburg GbRMarburg, 35037, Germany
Completed
Klinikum KonstanzKonstanz, 78464, Germany
Withdrawn
Medizinische Fakultät der Otto-von-Guericke UniversitätMagdeburg, 39112, Germany
Completed
IsalaZWOLLE, 8025 AB, Netherlands
Completed
Catharina ZiekenhuisEINDHOVEN, 5623 EJ, Netherlands
Withdrawn
Clinical Research InstituteMinneapolis, 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 ambulanceKralupy nad Vltavou, 278 01, Czechia
Completed
MUDr. Milan SklenarVarnsdorf, 407 47, Czechia
Completed
National Taiwan University HospitalTaipei, 100, Taiwan
Completed
Chang Gung Memorial Hospital KeelungKeelung, 20401, Taiwan
Completed
Taichung Veterans General HospitalTaichung, 40705, Taiwan
Completed
Taipei Medical University HospitalTaipei, 110, Taiwan
Completed
Far Eastern Memorial HospitalNew Taipei City, 220, Taiwan
Completed
Ostrowieckie Centrum Medyczne Sp. Cyw. A.O-C. K.C.Ostrowiec Swietokrzyski, 27-400, Poland
Completed
KLIMED Marek KlimkiewiczBychawa, 23-100, Poland
Completed
Centrum Alergologii Sp. z o.o.Lublin, 20-552, Poland
Completed
Centrum Medyczne Lucyna Andrzej DymekStrzelce Opolskie, 47-100, Poland
Completed
Centrum Medycyny Oddechowej Mroz Spolka JawnaBialystok, 15-044, Poland
Completed
Castle Hill HospitalCottingham, HU16 5JQ, United Kingdom
Completed
King's College Hospital - NHS Foundation TrustLondon, SE5 9RS, United Kingdom
Completed
University Hospital of South ManchesterManchester, M23 9LT, United Kingdom
Completed
North Tyneside General HospitalNorth Shields, NE29 8NH, United Kingdom
Withdrawn
Queen's UniversityBelfast, BT9 7AB, United Kingdom
Withdrawn
Oxford University HospitalsOxford, OX9 3DU, United Kingdom
Completed
West Walk SurgeryBristol, BS37 4AX, United Kingdom
Completed
Vanderbilt University Medical SchoolNashville, 37212-1610, United States
Completed
CHU de Toulouse - Hôpital LarreyTOULOUSE Cedex 9, 31059, France
Completed
Cochin - ParisPARIS, 75674, France
Withdrawn
ASST Fatebenefratelli SaccoMilano, 20157, Italy
Withdrawn
University of CalgaryCalgary, T2N 4Z6, Canada
Withdrawn
McMaster UniversityHamilton, L8N 3Z5, Canada
Completed
Burlington Lung Clinic (BLC) Clinical ResearchBurlington, L7N 3V2, Canada
Withdrawn
Inspiration Research LimitedToronto, M5T 3A9, Canada
Completed
Clinique de pneumologie et du sommeil de Lanaudière (CPSL)St-Charles-Borromée, J6E 2B4, Canada
Completed
Western Respiratory Trial SpecialistsSpearwood, 6163, Australia
Completed
Holdsworth House Medical PracticeSydney, 2010, Australia
Withdrawn
John Hunter HospitalNew Lambton Heights, 2305, Australia
Completed
Maroubra Medical CentreMaroubra, 2035, Australia
Completed
Macquarie University HospitalMacquarie University, 2109, Australia
Completed
Royal Adelaide HospitalAdelaide, 5000, Australia
Completed
D.Kenessey A HospitalBalassagyarmat, 2660, Hungary
Completed
Erzsebet GondozohazGodollo, 2100, Hungary
Completed
Da Vinci MaganklinikaPecs, 7635, Hungary
Completed
Farmakontroll Bt.Szazhalombatta, 2440, Hungary
Completed
EKBC, Uj Szent Janos Korhaz es SzakrendeloBudapest, 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 HospitalNagoya, 467-8602, Japan
Completed
Japan community health care organization Kanazawa HospitalKanazawa, 920-8610, Japan
Completed
Idaimae Minami YojoSapporo, 064-0804, Japan
Withdrawn
Kobe City Medical Center West HospitalKobe, 653-0013, Japan
Completed
Matsusaka Municipal HospitalMatsusaka, 515-8544, Japan
Completed
Komatsu Municipal HospitalKomatsu, 923-8560, Japan
Completed
University of Occupational and Environmental HealthKitakyushu, 807-8556, Japan
Completed
Saiseikai Yokohamashi Nanbu HospitalYokohama, 234-8503, Japan
Completed
Yokohama City Minato Red Cross HospitalYokohama, 231-8682, Japan
Completed
Fukushima Medical University HospitalFukushima, 960-1295, Japan
Completed
Hamamatsu Rosai HospitalHamamatsu, 430-8525, Japan
Withdrawn
Kanagawa Cardiovascular and Respiratory CenterYokohama, 236-0051, Japan
Completed
Tokyo Shinagawa HospitalShinagawa-ku, 140-8522, Japan
Completed
University of Fukui HospitalYoshida, 910-1193, Japan
Completed
Florida PediatricsLargo, 33778, United States
Withdrawn
Osaka Saiseikai Nakatsu HospitalOsaka, 530-0012, Japan
Withdrawn
National Hospital Organization Kanazawa Medical CenterKanazawa, 920-8650, Japan
Withdrawn
Sagamihara National HospitalSagamihara, 252-0392, Japan

Primary Outcome

  • Change from baseline in 24-hour cough count after 12 weeks of intervention
    Measured 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 intervention
    Measured 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 intervention
    Measured 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 intervention
    Measured 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 intervention
    Measured 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 intervention
    Measured 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 intervention
    Measured 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 intervention
    Measured 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 severity
    Safety 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

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)
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Randomized
Blinding
N/A
Assignment
Parallel Assignment
Trial Arms
4

Additional Information

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