Clinical trial NCT04562155: Clinical Study to Evaluate the Efficacy and Safety of Three Different Doses of BAY1817080 Compared to Placebo in Patients With Chronic Cough
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Refractory and/or Unexplained Chronic Cough
Keywords: RUCC
Chronic cough
P2X3 receptor antagonist
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2020-09-24
Enrollment: 310
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change From Baseline in 24-hour Cough Count After 12 Weeks of Intervention
timeFrame: From baseline up to 12 weeks
Secondary outcomes:
measure: Percentage of Participants With a ≥30% Reduction From Baseline in 24-hour Cough Count After 12 Weeks of Intervention
timeFrame: From baseline up to 12 weeks
measure: Change From Baseline in 24-hour Cough Count After 2, 4, and 8 Weeks of Intervention
timeFrame: From baseline up to 2 weeks, 4 weeks and 8 weeks
measure: Change From Baseline in Awake Cough Frequency Per Hour After 2, 4, 8 and 12 Weeks of Intervention
timeFrame: From baseline up to 2 weeks, 4 weeks, 8 weeks and 12 weeks
measure: Change From Baseline in Cough Related Quality of Life After 12 Weeks of Intervention
timeFrame: From baseline up to 12 weeks
measure: Change From Baseline in Cough Severity After 12 Weeks of Intervention
timeFrame: From baseline up to 12 weeks
measure: Percentage of Participants With a ≥30 Scale Units Reduction From Baseline After 12 Weeks of Intervention
timeFrame: From baseline up to 12 weeks
measure: Percentage of Participants With a ≥1.3-point Increase From Baseline After 12 Weeks of Intervention
timeFrame: From baseline up to 12 weeks
measure: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Associated Severity
timeFrame: From the start of study intervention administration until 14 days after the last study medication intake, with an average of 80.0 + 14 days
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: California Allergy & Asthma Medical Group & Research Center
state: California
city: Largo
country: United States
facility: Florida Pediatrics
state: Florida
city: White Marsh
country: United States
facility: Chesapeake Clinical Research, Inc.
state: Maryland
city: Edina
country: United States
facility: Minnesota Lung Center
state: Minnesota
city: Missoula
country: United States
facility: Montana Medical Research, Inc
state: Montana
city: Nashville
country: United States
facility: Vanderbilt University Medical School
state: Tennessee
city: Dallas
country: United States
facility: Pharmaceutical Research & Consulting, Inc.
state: Texas
city: Bellingham
country: United States
facility: Bellingham Asthma, Allergy & Immunology Clinic
state: Washington
city: Mar del Plata
country: Argentina
facility: Instituto Ave Pulmo
state: Buenos Aires
city: Quilmes
country: Argentina
facility: Centro Respiratorio Quilmes
state: Buenos Aires
city: Buenos Aires
country: Argentina
facility: Centro Médico Dra. De Salvo - Clinical Research Center
state: Ciudad Auton. De Buenos Aires
city: Caba
country: Argentina
facility: Centro de Investigaciones Clínicas
state: Ciudad Auton. De Buenos Aires
city: Caba
country: Argentina
facility: Fundación CIDEA
state: Ciudad Auton. De Buenos Aires
city: Caba
country: Argentina
facility: Investigación en Alergias y Enfermedades Respiratorias-INAER
state: Ciudad Auton. De Buenos Aires
city: San Miguel de Tucumán
country: Argentina
facility: Investigaciones en Patologías Respiratorias
state: Tucuman
city: Macquarie University
country: Australia
facility: Macquarie University Hospital
state: New South Wales
city: Maroubra
country: Australia
facility: Maroubra Medical Centre
state: New South Wales
city: Sydney
country: Australia
facility: Holdsworth House Medical Practice
state: New South Wales
city: Adelaide
country: Australia
facility: Royal Adelaide Hospital
state: South Australia
city: Spearwood
country: Australia
facility: Western Respiratory Trial Specialists
state: Western Australia
city: Erpent
country: Belgium
facility: Dr. MARTINOT Jean-Benoît
city: Gent
country: Belgium
facility: UZ Gent
city: Leuven
country: Belgium
facility: UZ Leuven Gasthuisberg
city: Liege
country: Belgium
facility: CHU de Liège
city: Mechelen
country: Belgium
facility: VZW Emmaus
city: Burlington
country: Canada
facility: Burlington Lung Clinic (BLC) Clinical Research
state: Ontario
city: St-Charles-Borromée
country: Canada
facility: Clinique de pneumologie et du sommeil de Lanaudière (CPSL)
state: Quebec
city: Kralupy nad Vltavou
country: Czechia
facility: MUDr Otakar Hokynar - Plicni ambulance
city: Olomouc
country: Czechia
facility: Ordinace pro TBC a respiracni nemoci, s.r.o.
city: Praha 4
country: Czechia
facility: Dawon s.r.o.
city: Teplice
country: Czechia
facility: Plicní stredisko Teplice, s.r.o.
city: Varnsdorf
country: Czechia
facility: MUDr. Milan Sklenar
city: Paris
country: France
facility: Cochin - Paris
city: TOULOUSE Cedex 9
country: France
facility: CHU de Toulouse - Hôpital Larrey
city: Konstanz
country: Germany
facility: Klinikum Konstanz
state: Baden-Württemberg
city: Marburg
country: Germany
facility: Zentrum f. ambulante pneumologische Forschung Marburg GbR
state: Hessen
city: Neu-Isenburg
country: Germany
facility: Ballenberger, Freytag, Wenisch
state: Hessen
city: Hannover
country: Germany
facility: Pneumologicum im Südstadt Forum
state: Niedersachsen
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover (MHH)
state: Niedersachsen
city: Leipzig
country: Germany
facility: Priv.-Doz. Dr. med. Christian Gessner
state: Sachsen
city: Berlin
country: Germany
facility: Praxis f. Lungen- und Bronchialheilkunde,
city: Balassagyarmat
country: Hungary
facility: D.Kenessey A Hospital
city: Budapest
country: Hungary
facility: EKBC, Uj Szent Janos Korhaz es Szakrendelo
city: Godollo
country: Hungary
facility: Erzsebet Gondozohaz
city: Pecs
country: Hungary
facility: Da Vinci Maganklinika
city: Szazhalombatta
country: Hungary
facility: Farmakontroll Bt.
city: Lodi
country: Italy
facility: ASST Lodi
state: Lombardia
city: Firenze
country: Italy
facility: A.O.U. Careggi
state: Toscana
city: Verona
country: Italy
facility: IRCCS Ospedale Sacro Cuore Don Calabria
state: Veneto
city: Verona
country: Italy
facility: A.O.U.I. Verona
state: Veneto
city: Nagoya
country: Japan
facility: Nagoya City University Hospital
state: Aichi
city: Yoshida
country: Japan
facility: University of Fukui Hospital
state: Fukui
city: Kitakyushu
country: Japan
facility: University of Occupational and Environmental Health
state: Fukuoka
city: Sapporo
country: Japan
facility: Idaimae Minami Yojo
state: Hokkaido
city: Kanazawa
country: Japan
facility: Japan community health care organization Kanazawa Hospital
state: Ishikawa
city: Komatsu
country: Japan
facility: Komatsu Municipal Hospital
state: Ishikawa
city: Yokohama
country: Japan
facility: Yokohama City Minato Red Cross Hospital
state: Kanagawa
city: Yokohama
country: Japan
facility: Saiseikai Yokohamashi Nanbu Hospital
state: Kanagawa
city: Matsusaka
country: Japan
facility: Matsusaka Municipal Hospital
state: Mie
city: Hamamatsu
country: Japan
facility: Hamamatsu Rosai Hospital
state: Shizuoka
city: Shinagawa-ku
country: Japan
facility: Tokyo Shinagawa Hospital
state: Tokyo
city: Fukushima
country: Japan
facility: Fukushima Medical University Hospital
city: Eindhoven
country: Netherlands
facility: Catharina Ziekenhuis
state: Noord-Brabant
city: Zwolle
country: Netherlands
facility: Isala
city: Bialystok
country: Poland
facility: Centrum Medycyny Oddechowej Mroz Spolka Jawna
city: Bychawa
country: Poland
facility: KLIMED Marek Klimkiewicz
city: Lublin
country: Poland
facility: Centrum Alergologii Sp. z o.o.
city: Ostrowiec Swietokrzyski
country: Poland
facility: Ostrowieckie Centrum Medyczne Sp. Cyw. A.O-C. K.C.
city: Strzelce Opolskie
country: Poland
facility: Centrum Medyczne Lucyna Andrzej Dymek
city: Kemerovo
country: Russian Federation
facility: Region Clinical Emergency Hospital n.a. M.A.Podgorbunskogo
city: Moscow
country: Russian Federation
facility: City Clinical Hospital n.a. D.D. Pletnev
city: Novosibirsk
country: Russian Federation
facility: LLC "Medical Center "SibNovoMed""
city: Samara
country: Russian Federation
facility: City Clinical Hospital #4 Samara
city: St. Petersburg
country: Russian Federation
facility: City Consultative and Diagnostic Center #1
city: St. Petersburg
country: Russian Federation
facility: LLC Astarta
city: Voronezh
country: Russian Federation
facility: Voronezh Regional Clinical Hospital #1
city: Bardejov
country: Slovakia
facility: ALIAN s.r.o.
city: Humenne
country: Slovakia
facility: INSPIRO, s.r.o.
city: Kezmarok
country: Slovakia
facility: AlergoImunocentrum, s.r.o.
city: Poprad
country: Slovakia
facility: Plucna ambulancia s.r.o.
city: Topolcany
country: Slovakia
facility: Ambulancia klin. imunologie a alergologie, ANA JJ, s.r.o.
city: Santiago de Compostela
country: Spain
facility: Hospital Clínico Universitario de Santiago de Compostela
state: A Coruña
city: Badalona
country: Spain
facility: Hospital Universitari Germans Trias i Pujol
state: Barcelona
city: Barcelona
country: Spain
facility: Hospital Clínic i Provincial de Barcelona
city: Keelung
country: Taiwan
facility: Chang Gung Memorial Hospital Keelung
city: New Taipei City
country: Taiwan
facility: Far Eastern Memorial Hospital
city: Taichung
country: Taiwan
facility: Taichung Veterans General Hospital
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: Taipei
country: Taiwan
facility: Taipei Medical University Hospital
city: Antalya
country: Turkey
facility: Akdeniz Universitesi Tip Fakultesi Hastanesi
city: Istanbul
country: Turkey
facility: Istanbul Universitesi Cerrahpasa-Cerrahpasa Tip Fakultesi
city: Izmir
country: Turkey
facility: Ege Universitesi Tip Fakultesi
city: Maltepe
country: Turkey
facility: Sureyyapasa Gogus Hasalikleri. ve Gogus Cerrahisi EAH
city: Mersin
country: Turkey
facility: Mersin Universitesi Tip Fakultesi
city: North Shields
country: United Kingdom
facility: North Tyneside General Hospital
state: Tyne And Wear
city: Bristol
country: United Kingdom
facility: West Walk Surgery
city: Cottingham
country: United Kingdom
facility: Castle Hill Hospital
city: London
country: United Kingdom
facility: King's College Hospital - NHS Foundation Trust
city: Manchester
country: United Kingdom
facility: University Hospital of South Manchester
Study officials:
References:
citation: 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.