Evaluation of the Efficacy and Safety of BLU-5937 in Adults With Refractory Chronic Cough
NCT ID: NCT04678206
Last Updated: 2021-12-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
310 participants
INTERVENTIONAL
2020-12-07
2021-11-02
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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BLU-5937 Dose A
BLU-5937 oral dose A twice a day.
BLU-5937
Oral administration of BLU-5937 Tablets
BLU-5937 Dose B
BLU-5937 oral dose B twice a day.
BLU-5937
Oral administration of BLU-5937 Tablets
BLU-5937 Dose C
BLU-5937 oral dose C twice a day.
BLU-5937
Oral administration of BLU-5937 Tablets
Placebo
Matching Placebo for BLU-5937 oral dose twice a day.
Placebo
Oral administration of matching placebo for BLU-5937 Tablets
BLU-5937 Dose A (Population with baseline cough < 25 coughs/hour)
BLU-5937 oral dose A twice a day.
BLU-5937
Oral administration of BLU-5937 Tablets
Placebo (Population with baseline cough < 25 coughs/hour)
Matching Placebo for BLU-5937 oral dose twice a day.
Placebo
Oral administration of matching placebo for BLU-5937 Tablets
Interventions
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BLU-5937
Oral administration of BLU-5937 Tablets
Placebo
Oral administration of matching placebo for BLU-5937 Tablets
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
80 Years
ALL
No
Sponsors
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Bellus Health Inc. - a GSK company
INDUSTRY
Responsible Party
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Locations
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Phoenix Medical Research Inc
Peoria, Arizona, United States
Little Rock Allergy and Asthma Clinical Research Center
Little Rock, Arkansas, United States
Southern California Institute For Respiratory Diseases, Inc
Los Angeles, California, United States
Allergy and Asthma Associates of Southern California
Mission Viejo, California, United States
California Medical Research Associates, Inc.
Northridge, California, United States
Allergy Associates Medical Group Inc.
San Diego, California, United States
Allergy and Asthma Associates of Santa Clara Valley Research Center
San Jose, California, United States
Colorado Allergy and Asthma Centers
Denver, Colorado, United States
St. Francis Medical Institute
Clearwater, Florida, United States
Floridian Clinical Research
Hialeah, Florida, United States
Sweet Hope Research Specialty, Inc.
Hialeah, Florida, United States
Sher Allergy Specialist/Center for Cough
Largo, Florida, United States
Medical Research of Central Florida
Leesburg, Florida, United States
ProCare Clinical Research
Miami Lakes, Florida, United States
Central Florida Pulmonary Group PA
Orlando, Florida, United States
Lenus Research & Medical Group
Sweetwater, Florida, United States
IACT Health - Columbus
Columbus, Georgia, United States
IACT Health - Lawrenceville
Lawrenceville, Georgia, United States
IACT Health - Rincon
Rincon, Georgia, United States
Sneeze Wheeze and Itch Associates LLC
Normal, Illinois, United States
AES - Synexus Clinical Research US, Inc. - Evansville
Evansville, Indiana, United States
Abraham Research PLLC
Fort Mitchell, Kentucky, United States
Infinity Medical Research Inc
North Dartmouth, Massachusetts, United States
Minnesota Lung Center
Edina, Minnesota, United States
Mayo Clinic
Rochester, Minnesota, United States
Minnesota Lung Center
Woodbury, Minnesota, United States
The Lung Research Center, LLC
Chesterfield, Missouri, United States
University of Missouri, ENT and Allergy Center of Missouri
Columbia, Missouri, United States
The Clinical Research Center LLC
St Louis, Missouri, United States
Montana Medical Research
Missoula, Montana, United States
Creighton University Medical Center
Omaha, Nebraska, United States
Atlantic Respiratory Institute
Summit, New Jersey, United States
Albuquerque Clinical Trials Inc
Albuquerque, New Mexico, United States
CHEAR Center LLC
The Bronx, New York, United States
American Health Research Inc
Charlotte, North Carolina, United States
Clinical Research of Gastonia
Gastonia, North Carolina, United States
Southeastern Research Center
Winston-Salem, North Carolina, United States
Bernstein Clinical Research Center Inc
Cincinnati, Ohio, United States
The Cleveland Clinic Foundation
Cleveland, Ohio, United States
Remington Davis Inc
Columbus, Ohio, United States
Vital Prospects Clinical Research Institute PC
Tulsa, Oklahoma, United States
Clinical Research Associates Of Central Pa
Altoona, Pennsylvania, United States
Synexus Clinical Research US, Inc.
Anderson, South Carolina, United States
National Allergy and Asthma Research
Charleston, South Carolina, United States
Clinical Research of Rock Hill
Rock Hill, South Carolina, United States
Clinical Trials Center of Middle Tennessee
Franklin, Tennessee, United States
Pharmaceutical Research & Consulting Inc
Dallas, Texas, United States
El Paso Pulmonary Association
El Paso, Texas, United States
Village Research, LLC
Houston, Texas, United States
Metroplex Pulmonary and Sleep Medicine Center
McKinney, Texas, United States
Diagnostics Research Group
San Antonio, Texas, United States
Sherman Clinical Research
Sherman, Texas, United States
Allergy Asthma Research Institute
Waco, Texas, United States
Intermountain Clinical Research
Draper, Utah, United States
TPMG Lung & Sleep Specialist
Williamsburg, Virginia, United States
McMaster University Medical Centre
Hamilton, Ontario, Canada
Diex Recherche - Québec
Québec, Quebec, Canada
Clinique Spécialisée en Allergie de la Capitale
Québec, Quebec, Canada
Inspiration Research Limited
Toronto, Quebec, Canada
C I C Maurice Inc
Trois-Rivières, Quebec, Canada
Diex Recherche - Victoriaville
Victoriaville, Quebec, Canada
MUDr. I. Cierná Peterová s.r.o.
Brandýs nad Labem-Stará Boleslav, Central Bohemia, Czechia
Pneumologie Varnsdorf S.r.o.
Nový Bor, Liberec, Czechia
Plicní ambulance Rokycany s.r.o.
Rokycany, Plzeň, Czechia
Synexus Czech s.r.o.
Prague, Prague, Czechia
MediTrial s.r.o.
Jindřichův Hradec, South Bohemia, Czechia
MUDr. Jaroslav Mares - odborny lekar pro obor tuberkulosa a respiracni nemoci
Strakonice, South Bohemia, Czechia
Plicni stredisko Teplice s.r.o.
Teplice, Ústí Nad Labem, Czechia
Thoraxklinik-Heidelberg gGmbH
Heidelberg, Baden-Wurttemberg, Germany
Synexus Frankfurt Research Centre
Frankfurt am Main, Hesse, Germany
IKF Pneumologie
Frankfurt am Main, Hesse, Germany
Zentrum für ambulante pneumologische Forschung Marburg GbR
Marburg, Hesse, Germany
Ballenberger. Freytag. Wenisch - Institut fuer klinische Forschung GmbH
Neu-Isenburg, Hesse, Germany
Kfns Klinische Forschung Schwerin
Schwerin, Mecklenburg-Vorpommern, Germany
Universitätsklinikum Bonn
Bonn, North Rhine-Westphalia, Germany
Klinische Forschung Dresden GmbH (KFGN)
Dresden, Saxony, Germany
Synexus Leipzig Research Centre
Leipzig, Saxony, Germany
Ärztezentrum Axel Springer Passage
Berlin, , Germany
Da Vinci Maganklinika
Pécs, Baranya, Hungary
Synexus Gyula - Magyarország Egészségügyi Szolgáltató Kft
Gyula, Bekes County, Hungary
Dr. Kenessey Albert Korhaz-Rendelointezet
Balassagyarmat, Nógrád megye, Hungary
Szent Borbála Kórház
Tatabánya, Nógrád megye, Hungary
Synexus Zalaegerszeg Magyarország Egészségügyi Kft
Zalaegerszeg, Zala County, Hungary
Synexus Budapest - Magyarország Egészségügyi Szolgáltató Kft
Budapest, , Hungary
Osrodek Badan Klinicznych CLINSANTE S.C. Ewa Galczak-Nowak Malgorzata Trzaska
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland
Medical Center Kermed
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland
Centrum Medyczne Bydgoszcz - PRATIA
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland
Alergo-Med Specjalistyczna Przychodnia Lekarska Sp. z.o.o
Tarnów, Lesser Poland Voivodeship, Poland
KLIMED
Bychawa, Lublin Voivodeship, Poland
Clinical Best Solutions -Lublin
Lublin, Lublin Voivodeship, Poland
Centrum Alergologii Specjalistyczna Przychodnia Alergologiczna
Lublin, Lublin Voivodeship, Poland
Centrum Medyczne Warszawa - PRATIA
Warsaw, Masovian Voivodeship, Poland
Prywatny Gabinet Internistyczno-Alergologiczny
Bialystok, Podlaskie Voivodeship, Poland
Synexus Polska Sp. z o.o. Oddzial w Gdansku
Gdansk, Pomeranian Voivodeship, Poland
Synexus Polska Sp. z o.o. Oddzial w Czestochowie
Częstochowa, Silesian Voivodeship, Poland
Centrum Medyczne Wos i Piwowarczyk
Kraków, Łódź Voivodeship, Poland
Synexus Polska Sp. Z o.o Oddzial w Lodzi
Lodz, Łódź Voivodeship, Poland
Ostrowieckie Centrum Medyczne Spólka Cywilna Anna Olech-Cudzik, Krzysztof Cudzik
Ostrowiec Świętokrzyski, Świętokrzyskie Voivodeship, Poland
Synexus Midlands Clinical Research Centre
Birmingham, England, United Kingdom
West Walk Surgery
Bristol, England, United Kingdom
MeDiNova Northamptonshire Quality Research Site
Corby, England, United Kingdom
Castle Hill Hospital
Cottingham, England, United Kingdom
MeDiNova Warwickshire Quality Research Site
Kenilworth, England, United Kingdom
Kings College Hospital
London, England, United Kingdom
Royal Brompton Hospital
London, England, United Kingdom
NW Consortium Manchester
Manchester, England, United Kingdom
Wythenshawe Hospital - PPDS
Manchester, England, United Kingdom
MeDiNova North London Quality Research Site
Middlesex, England, United Kingdom
North Tyneside General Hospital
North Shields, England, United Kingdom
MeDiNova East London Quality Research Site
Romford, England, United Kingdom
MeDiNova Yorkshire Quality Research Site
Shipley, England, United Kingdom
MeDiNova South London Quality Research Site
Sidcup, England, United Kingdom
MeDiNova West London Quality Research Site
Wokingham, England, United Kingdom
Ormeau Clinical Trials Limited
Belfast, Northern Ireland, United Kingdom
Belfast City Hospital
Belfast, Northern Ireland, United Kingdom
AES - Synexus Scotland Clinical Research Centre
Glasgow, Scotland, United Kingdom
Countries
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References
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Smith JA, Birring SS, Blaiss MS, McGarvey L, Morice AH, Sher M, Carroll KJ, Garin M, Lanouette S, Shaw J, Yang R, Bonuccelli CM. Camlipixant in Refractory Chronic Cough: A Phase 2b, Randomized, Placebo-controlled Trial (SOOTHE). Am J Respir Crit Care Med. 2025 Jun;211(6):1038-1048. doi: 10.1164/rccm.202409-1752OC.
Other Identifiers
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2020-004136-17
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
BUS-P2-02
Identifier Type: -
Identifier Source: org_study_id