Clinical trial NCT04678206: Evaluation of the Efficacy and Safety of BLU-5937 in Adults With Refractory Chronic Cough
Official title: A Randomized, Adaptive, Double-Blind, Placebo-Controlled, Parallel-Arm, Phase 2b Study to Evaluate the Efficacy and Safety of Multiple Doses of BLU-5937 in Adult Participants With Refractory Chronic Cough
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Refractory Chronic Cough
Keywords: BLU-5937
Refractory Chronic Cough
P2X3 receptor antagonist
Lead sponsor: Bellus Health Inc. - a GSK company
Sponsor class: INDUSTRY
First posted: 2020-12-21
Enrollment: 310
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel Assignment
Primary purpose: TREATMENT

Brief summary: This is a randomized, double-blind, placebo-controlled, parallel-arm, Phase 2b adaptive dose-finding study of BLU-5937 in participants with Refractory Chronic Cough (RCC).

Detailed description: The primary objective of this study is to determine the therapeutic dose of BLU-5937 in patients with refractory chronic cough by assessing the change from baseline to week 4 in the 24-hour cough frequency with BLU-5937 relative to placebo.

Eligibility criteria: Inclusion Criteria:

* Capable of giving signed informed consent
* Refractory chronic cough (including unexplained chronic cough) for at least one year
* Women of child-bearing potential must use a highly effective contraception method during the study and for at least 14 days after the last dose

Exclusion Criteria:

* Current smoker/vaper (all forms of smoking and inhaled substances, including , cannabis/tobacco smoke and nicotine vapors) or individuals who have given up smoking within the past 6 months, or those with \>20 pack-year smoking history
* Diagnosis of Chronic Obstructive Pulmonary Disease (COPD), bronchiectasis, idiopathic pulmonary fibrosis or uncontrolled asthma
* Respiratory tract infection within 4 weeks before screening
* Laboratory confirmed Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) infection at screening
* History of malignancy in the last 5 years
* History of alcohol or drug abuse within the last 3 years
* Has a positive serologic test for human immunodeficiency virus (HIV), hepatitis B virus surface antigen, or hepatitis C virus.
* Previous participation in a BLU-5937 trial

Primary outcomes:
measure: Change from baseline in the 24-hour cough frequency
timeFrame: Week 4
Secondary outcomes:
measure: Percentage of Participants with a Reduction from Baseline in the 24-hour Cough Frequency by ≥ 30%, 50% and 70%
timeFrame: Week 4
measure: Change from Baseline in Leicester Cough Questionnaire (LCQ)
timeFrame: Week 4
measure: Change from baseline in cough severity
timeFrame: Week 4
measure: Incidence (% of subjects) of treatment-emergent adverse events (TEAEs)
timeFrame: 2 Weeks after the last study medication intake
measure: Severity (mild, moderate, or severe) of treatment-emergent adverse events (TEAEs)
timeFrame: 2 Weeks after the last study medication intake
Other outcomes:
Locations:
city: Peoria
country: United States
facility: Phoenix Medical Research Inc
state: Arizona
city: Little Rock
country: United States
facility: Little Rock Allergy and Asthma Clinical Research Center
state: Arkansas
city: Los Angeles
country: United States
facility: Southern California Institute For Respiratory Diseases, Inc
state: California
city: Mission Viejo
country: United States
facility: Allergy and Asthma Associates of Southern California
state: California
city: Northridge
country: United States
facility: California Medical Research Associates, Inc.
state: California
city: San Diego
country: United States
facility: Allergy Associates Medical Group Inc.
state: California
city: San Jose
country: United States
facility: Allergy and Asthma Associates of Santa Clara Valley Research Center
state: California
city: Denver
country: United States
facility: Colorado Allergy and Asthma Centers
state: Colorado
city: Clearwater
country: United States
facility: St. Francis Medical Institute
state: Florida
city: Hialeah
country: United States
facility: Floridian Clinical Research
state: Florida
city: Hialeah
country: United States
facility: Sweet Hope Research Specialty, Inc.
state: Florida
city: Largo
country: United States
facility: Sher Allergy Specialist/Center for Cough
state: Florida
city: Leesburg
country: United States
facility: Medical Research of Central Florida
state: Florida
city: Miami Lakes
country: United States
facility: ProCare Clinical Research
state: Florida
city: Orlando
country: United States
facility: Central Florida Pulmonary Group PA
state: Florida
city: Sweetwater
country: United States
facility: Lenus Research & Medical Group
state: Florida
city: Columbus
country: United States
facility: IACT Health - Columbus
state: Georgia
city: Lawrenceville
country: United States
facility: IACT Health - Lawrenceville
state: Georgia
city: Rincon
country: United States
facility: IACT Health - Rincon
state: Georgia
city: Normal
country: United States
facility: Sneeze Wheeze and Itch Associates LLC
state: Illinois
city: Evansville
country: United States
facility: AES - Synexus Clinical Research US, Inc. - Evansville
state: Indiana
city: Fort Mitchell
country: United States
facility: Abraham Research PLLC
state: Kentucky
city: North Dartmouth
country: United States
facility: Infinity Medical Research Inc
state: Massachusetts
city: Edina
country: United States
facility: Minnesota Lung Center
state: Minnesota
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Woodbury
country: United States
facility: Minnesota Lung Center
state: Minnesota
city: Chesterfield
country: United States
facility: The Lung Research Center, LLC
state: Missouri
city: Columbia
country: United States
facility: University of Missouri, ENT and Allergy Center of Missouri
state: Missouri
city: Saint Louis
country: United States
facility: The Clinical Research Center LLC
state: Missouri
city: Missoula
country: United States
facility: Montana Medical Research
state: Montana
city: Omaha
country: United States
facility: Creighton University Medical Center
state: Nebraska
city: Summit
country: United States
facility: Atlantic Respiratory Institute
state: New Jersey
city: Albuquerque
country: United States
facility: Albuquerque Clinical Trials Inc
state: New Mexico
city: Bronx
country: United States
facility: CHEAR Center LLC
state: New York
city: Charlotte
country: United States
facility: American Health Research Inc
state: North Carolina
city: Gastonia
country: United States
facility: Clinical Research of Gastonia
state: North Carolina
city: Winston-Salem
country: United States
facility: Southeastern Research Center
state: North Carolina
city: Cincinnati
country: United States
facility: Bernstein Clinical Research Center Inc
state: Ohio
city: Cleveland
country: United States
facility: The Cleveland Clinic Foundation
state: Ohio
city: Columbus
country: United States
facility: Remington Davis Inc
state: Ohio
city: Tulsa
country: United States
facility: Vital Prospects Clinical Research Institute PC
state: Oklahoma
city: Altoona
country: United States
facility: Clinical Research Associates Of Central Pa
state: Pennsylvania
city: Anderson
country: United States
facility: Synexus Clinical Research US, Inc.
state: South Carolina
city: Charleston
country: United States
facility: National Allergy and Asthma Research
state: South Carolina
city: Rock Hill
country: United States
facility: Clinical Research of Rock Hill
state: South Carolina
city: Franklin
country: United States
facility: Clinical Trials Center of Middle Tennessee
state: Tennessee
city: Dallas
country: United States
facility: Pharmaceutical Research & Consulting Inc
state: Texas
city: El Paso
country: United States
facility: El Paso Pulmonary Association
state: Texas
city: Houston
country: United States
facility: Village Research, LLC
state: Texas
city: McKinney
country: United States
facility: Metroplex Pulmonary and Sleep Medicine Center
state: Texas
city: San Antonio
country: United States
facility: Diagnostics Research Group
state: Texas
city: Sherman
country: United States
facility: Sherman Clinical Research
state: Texas
city: Waco
country: United States
facility: Allergy Asthma Research Institute
state: Texas
city: Draper
country: United States
facility: Intermountain Clinical Research
state: Utah
city: Williamsburg
country: United States
facility: TPMG Lung & Sleep Specialist
state: Virginia
city: Hamilton
country: Canada
facility: McMaster University Medical Centre
state: Ontario
city: Québec
country: Canada
facility: Diex Recherche - Québec
state: Quebec
city: Québec
country: Canada
facility: Clinique Spécialisée en Allergie de la Capitale
state: Quebec
city: Toronto
country: Canada
facility: Inspiration Research Limited
state: Quebec
city: Trois-Rivières
country: Canada
facility: C I C Maurice Inc
state: Quebec
city: Victoriaville
country: Canada
facility: Diex Recherche - Victoriaville
state: Quebec
city: Brandýs Nad Labem-Stará Boleslav
country: Czechia
facility: MUDr. I. Cierná Peterová s.r.o.
state: Central Bohemia
city: Nový Bor
country: Czechia
facility: Pneumologie Varnsdorf S.r.o.
state: Liberec
city: Rokycany
country: Czechia
facility: Plicní ambulance Rokycany s.r.o.
state: Plzeň
city: Praha
country: Czechia
facility: Synexus Czech s.r.o.
state: Prague
city: Jindřichův Hradec
country: Czechia
facility: MediTrial s.r.o.
state: South Bohemia
city: Strakonice
country: Czechia
facility: MUDr. Jaroslav Mares - odborny lekar pro obor tuberkulosa a respiracni nemoci
state: South Bohemia
city: Teplice
country: Czechia
facility: Plicni stredisko Teplice s.r.o.
state: Ústí Nad Labem
city: Heidelberg
country: Germany
facility: Thoraxklinik-Heidelberg gGmbH
state: Baden-Württemberg
city: Frankfurt am main
country: Germany
facility: Synexus Frankfurt Research Centre
state: Hessen
city: Frankfurt
country: Germany
facility: IKF Pneumologie
state: Hessen
city: Marburg
country: Germany
facility: Zentrum für ambulante pneumologische Forschung Marburg GbR
state: Hessen
city: Neu Isenburg
country: Germany
facility: Ballenberger. Freytag. Wenisch - Institut fuer klinische Forschung GmbH
state: Hessen
city: Schwerin
country: Germany
facility: Kfns Klinische Forschung Schwerin
state: Mecklenburg-Vorpommern
city: Bonn
country: Germany
facility: Universitätsklinikum Bonn
state: Nordrhein-Westfalen
city: Dresden
country: Germany
facility: Klinische Forschung Dresden GmbH (KFGN)
state: Sachsen
city: Leipzig
country: Germany
facility: Synexus Leipzig Research Centre
state: Sachsen
city: Berlin
country: Germany
facility: Ärztezentrum Axel Springer Passage
city: Pécs
country: Hungary
facility: Da Vinci Maganklinika
state: Baranya
city: Gyula
country: Hungary
facility: Synexus Gyula - Magyarország Egészségügyi Szolgáltató Kft
state: Békés
city: Tatabánya
country: Hungary
facility: Szent Borbála Kórház
state: Nograd
city: Balassagyarmat
country: Hungary
facility: Dr. Kenessey Albert Korhaz-Rendelointezet
state: Nógrád
city: Zalaegerszeg
country: Hungary
facility: Synexus Zalaegerszeg Magyarország Egészségügyi Kft
state: Zala
city: Budapest
country: Hungary
facility: Synexus Budapest - Magyarország Egészségügyi Szolgáltató Kft
city: Bydgoszcz
country: Poland
facility: Osrodek Badan Klinicznych CLINSANTE S.C. Ewa Galczak-Nowak Malgorzata Trzaska
state: Kujawsko-pomorskie
city: Bydgoszcz
country: Poland
facility: Medical Center Kermed
state: Kujawsko-pomorskie
city: Bydgoszcz
country: Poland
facility: Centrum Medyczne Bydgoszcz - PRATIA
state: Kujawsko-pomorskie
city: Łódź
country: Poland
facility: Synexus Polska Sp. Z o.o Oddzial w Lodzi
state: Lodzkie
city: Bychawa
country: Poland
facility: KLIMED
state: Lubelskie
city: Lublin
country: Poland
facility: Clinical Best Solutions -Lublin
state: Lubelskie
city: Lublin
country: Poland
facility: Centrum Alergologii Specjalistyczna Przychodnia Alergologiczna
state: Lubelskie
city: Warszawa
country: Poland
facility: Centrum Medyczne Warszawa - PRATIA
state: Mazowieckie
city: Tarnów
country: Poland
facility: Alergo-Med Specjalistyczna Przychodnia Lekarska Sp. z.o.o
state: Małopolskie
city: Białystok
country: Poland
facility: Prywatny Gabinet Internistyczno-Alergologiczny
state: Podlaskie
city: Gdansk
country: Poland
facility: Synexus Polska Sp. z o.o. Oddzial w Gdansku
state: Pomorskie
city: Kraków
country: Poland
facility: Centrum Medyczne Wos i Piwowarczyk
state: Łódzkie
city: Częstochowa
country: Poland
facility: Synexus Polska Sp. z o.o. Oddzial w Czestochowie
state: Śląskie
city: Ostrowiec Świętokrzyski
country: Poland
facility: Ostrowieckie Centrum Medyczne Spólka Cywilna Anna Olech-Cudzik, Krzysztof Cudzik
state: Świętokrzyskie
city: Birmingham
country: United Kingdom
facility: Synexus Midlands Clinical Research Centre
state: England
city: Bristol
country: United Kingdom
facility: West Walk Surgery
state: England
city: Corby
country: United Kingdom
facility: MeDiNova Northamptonshire Quality Research Site
state: England
city: Cottingham
country: United Kingdom
facility: Castle Hill Hospital
state: England
city: Kenilworth
country: United Kingdom
facility: MeDiNova Warwickshire Quality Research Site
state: England
city: London
country: United Kingdom
facility: Kings College Hospital
state: England
city: London
country: United Kingdom
facility: Royal Brompton Hospital
state: England
city: Manchester
country: United Kingdom
facility: NW Consortium Manchester
state: England
city: Manchester
country: United Kingdom
facility: Wythenshawe Hospital - PPDS
state: England
city: Middlesex
country: United Kingdom
facility: MeDiNova North London Quality Research Site
state: England
city: North Shields
country: United Kingdom
facility: North Tyneside General Hospital
state: England
city: Romford
country: United Kingdom
facility: MeDiNova East London Quality Research Site
state: England
city: Shipley
country: United Kingdom
facility: MeDiNova Yorkshire Quality Research Site
state: England
city: Sidcup
country: United Kingdom
facility: MeDiNova South London Quality Research Site
state: England
city: Wokingham
country: United Kingdom
facility: MeDiNova West London Quality Research Site
state: England
city: Belfast
country: United Kingdom
facility: Ormeau Clinical Trials Limited
state: Northern Ireland
city: Belfast
country: United Kingdom
facility: Belfast City Hospital
state: Northern Ireland
city: Glasgow
country: United Kingdom
facility: AES - Synexus Scotland Clinical Research Centre
state: Scotland
Study officials:
References: