Evaluation of the Efficacy and Safety of BLU-5937 in Adults With Refractory Chronic Cough
SOOTHE
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
2 other identifiers
interventional
310
7 countries
116
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Dec 2020
Shorter than P25 for phase_2
116 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 7, 2020
CompletedFirst Submitted
Initial submission to the registry
December 9, 2020
CompletedFirst Posted
Study publicly available on registry
December 21, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 21, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
November 2, 2021
CompletedDecember 13, 2021
December 1, 2021
11 months
December 9, 2020
December 10, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from baseline in the 24-hour cough frequency
Assessed using an ambulatory cough monitor
Week 4
Secondary Outcomes (5)
Percentage of Participants with a Reduction from Baseline in the 24-hour Cough Frequency by ≥ 30%, 50% and 70%
Week 4
Change from Baseline in Leicester Cough Questionnaire (LCQ)
Week 4
Change from baseline in cough severity
Week 4
Incidence (% of subjects) of treatment-emergent adverse events (TEAEs)
2 Weeks after the last study medication intake
Severity (mild, moderate, or severe) of treatment-emergent adverse events (TEAEs)
2 Weeks after the last study medication intake
Study Arms (6)
BLU-5937 Dose A
EXPERIMENTALBLU-5937 oral dose A twice a day.
BLU-5937 Dose B
EXPERIMENTALBLU-5937 oral dose B twice a day.
BLU-5937 Dose C
EXPERIMENTALBLU-5937 oral dose C twice a day.
Placebo
PLACEBO COMPARATORMatching Placebo for BLU-5937 oral dose twice a day.
BLU-5937 Dose A (Population with baseline cough < 25 coughs/hour)
EXPERIMENTALBLU-5937 oral dose A twice a day.
Placebo (Population with baseline cough < 25 coughs/hour)
PLACEBO COMPARATORMatching Placebo for BLU-5937 oral dose twice a day.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (116)
Phoenix Medical Research Inc
Peoria, Arizona, 85381, United States
Little Rock Allergy and Asthma Clinical Research Center
Little Rock, Arkansas, 21237, United States
Southern California Institute For Respiratory Diseases, Inc
Los Angeles, California, 90048, United States
Allergy and Asthma Associates of Southern California
Mission Viejo, California, 92691, United States
California Medical Research Associates, Inc.
Northridge, California, 91324, United States
Allergy Associates Medical Group Inc.
San Diego, California, 92120, United States
Allergy and Asthma Associates of Santa Clara Valley Research Center
San Jose, California, 95117, United States
Colorado Allergy and Asthma Centers
Denver, Colorado, 80230, United States
St. Francis Medical Institute
Clearwater, Florida, 33765, United States
Floridian Clinical Research
Hialeah, Florida, 33016, United States
Sweet Hope Research Specialty, Inc.
Hialeah, Florida, 33016, United States
Sher Allergy Specialist/Center for Cough
Largo, Florida, 33778, United States
Medical Research of Central Florida
Leesburg, Florida, 34748, United States
ProCare Clinical Research
Miami Lakes, Florida, 33014, United States
Central Florida Pulmonary Group PA
Orlando, Florida, 32803, United States
Lenus Research & Medical Group
Sweetwater, Florida, 33172, United States
IACT Health - Columbus
Columbus, Georgia, 31904, United States
IACT Health - Lawrenceville
Lawrenceville, Georgia, 30046, United States
IACT Health - Rincon
Rincon, Georgia, 31326, United States
Sneeze Wheeze and Itch Associates LLC
Normal, Illinois, 61761, United States
AES - Synexus Clinical Research US, Inc. - Evansville
Evansville, Indiana, 47714, United States
Abraham Research PLLC
Fort Mitchell, Kentucky, 41017, United States
Infinity Medical Research Inc
North Dartmouth, Massachusetts, 02747, United States
Minnesota Lung Center
Edina, Minnesota, 55435, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
Minnesota Lung Center
Woodbury, Minnesota, 55125, United States
The Lung Research Center, LLC
Chesterfield, Missouri, 63017, United States
University of Missouri, ENT and Allergy Center of Missouri
Columbia, Missouri, 65201, United States
The Clinical Research Center LLC
St Louis, Missouri, 63141, United States
Montana Medical Research
Missoula, Montana, 59808, United States
Creighton University Medical Center
Omaha, Nebraska, 68124, United States
Atlantic Respiratory Institute
Summit, New Jersey, 07901, United States
Albuquerque Clinical Trials Inc
Albuquerque, New Mexico, 87102, United States
CHEAR Center LLC
The Bronx, New York, 10455, United States
American Health Research Inc
Charlotte, North Carolina, 28277, United States
Clinical Research of Gastonia
Gastonia, North Carolina, 28054, United States
Southeastern Research Center
Winston-Salem, North Carolina, 27103, United States
Bernstein Clinical Research Center Inc
Cincinnati, Ohio, 45231, United States
The Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
Remington Davis Inc
Columbus, Ohio, 43215, United States
Vital Prospects Clinical Research Institute PC
Tulsa, Oklahoma, 74136, United States
Clinical Research Associates Of Central Pa
Altoona, Pennsylvania, 16601, United States
Synexus Clinical Research US, Inc.
Anderson, South Carolina, 29621, United States
National Allergy and Asthma Research
Charleston, South Carolina, 29420, United States
Clinical Research of Rock Hill
Rock Hill, South Carolina, 29732, United States
Clinical Trials Center of Middle Tennessee
Franklin, Tennessee, 37067, United States
Pharmaceutical Research & Consulting Inc
Dallas, Texas, 75231, United States
El Paso Pulmonary Association
El Paso, Texas, 79902, United States
Village Research, LLC
Houston, Texas, 77084, United States
Metroplex Pulmonary and Sleep Medicine Center
McKinney, Texas, 75069, United States
Diagnostics Research Group
San Antonio, Texas, 78229, United States
Sherman Clinical Research
Sherman, Texas, 75092, United States
Allergy Asthma Research Institute
Waco, Texas, 76712, United States
Intermountain Clinical Research
Draper, Utah, 84020, United States
TPMG Lung & Sleep Specialist
Williamsburg, Virginia, 23188, United States
McMaster University Medical Centre
Hamilton, Ontario, L8N 3Z5, Canada
Diex Recherche - Québec
Québec, Quebec, G1N 4V3, Canada
Clinique Spécialisée en Allergie de la Capitale
Québec, Quebec, G1V 4W2, Canada
Inspiration Research Limited
Toronto, Quebec, M5T 3A9, Canada
C I C Maurice Inc
Trois-Rivières, Quebec, G8T 7A1, Canada
Diex Recherche - Victoriaville
Victoriaville, Quebec, G6P 6P6, Canada
MUDr. I. Cierná Peterová s.r.o.
Brandýs nad Labem-Stará Boleslav, Central Bohemia, 250 01, Czechia
Pneumologie Varnsdorf S.r.o.
Nový Bor, Liberec, 473 01, Czechia
Plicní ambulance Rokycany s.r.o.
Rokycany, Plzeň, 33701, Czechia
Synexus Czech s.r.o.
Prague, Prague, 120 00, Czechia
MediTrial s.r.o.
Jindřichův Hradec, South Bohemia, 377 01, Czechia
MUDr. Jaroslav Mares - odborny lekar pro obor tuberkulosa a respiracni nemoci
Strakonice, South Bohemia, 386 01, Czechia
Plicni stredisko Teplice s.r.o.
Teplice, Ústí Nad Labem, 415 01, Czechia
Thoraxklinik-Heidelberg gGmbH
Heidelberg, Baden-Wurttemberg, 69126, Germany
Synexus Frankfurt Research Centre
Frankfurt am Main, Hesse, 60313, Germany
IKF Pneumologie
Frankfurt am Main, Hesse, 60596, Germany
Zentrum für ambulante pneumologische Forschung Marburg GbR
Marburg, Hesse, 35037, Germany
Ballenberger. Freytag. Wenisch - Institut fuer klinische Forschung GmbH
Neu-Isenburg, Hesse, 63263, Germany
Kfns Klinische Forschung Schwerin
Schwerin, Mecklenburg-Vorpommern, 19055, Germany
Universitätsklinikum Bonn
Bonn, North Rhine-Westphalia, 53127, Germany
Klinische Forschung Dresden GmbH (KFGN)
Dresden, Saxony, 01069, Germany
Synexus Leipzig Research Centre
Leipzig, Saxony, 04103, Germany
Ärztezentrum Axel Springer Passage
Berlin, 10969, Germany
Da Vinci Maganklinika
Pécs, Baranya, 7635, Hungary
Synexus Gyula - Magyarország Egészségügyi Szolgáltató Kft
Gyula, Bekes County, 5700, Hungary
Dr. Kenessey Albert Korhaz-Rendelointezet
Balassagyarmat, Nógrád megye, 2660, Hungary
Szent Borbála Kórház
Tatabánya, Nógrád megye, 2800, Hungary
Synexus Zalaegerszeg Magyarország Egészségügyi Kft
Zalaegerszeg, Zala County, 8900, Hungary
Synexus Budapest - Magyarország Egészségügyi Szolgáltató Kft
Budapest, 1036, Hungary
Osrodek Badan Klinicznych CLINSANTE S.C. Ewa Galczak-Nowak Malgorzata Trzaska
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 31-826, Poland
Medical Center Kermed
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-231, Poland
Centrum Medyczne Bydgoszcz - PRATIA
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-796, Poland
Alergo-Med Specjalistyczna Przychodnia Lekarska Sp. z.o.o
Tarnów, Lesser Poland Voivodeship, 33-100, Poland
KLIMED
Bychawa, Lublin Voivodeship, 23-100, Poland
Clinical Best Solutions -Lublin
Lublin, Lublin Voivodeship, 20-078, Poland
Centrum Alergologii Specjalistyczna Przychodnia Alergologiczna
Lublin, Lublin Voivodeship, 20-552, Poland
Centrum Medyczne Warszawa - PRATIA
Warsaw, Masovian Voivodeship, 01-869, Poland
Prywatny Gabinet Internistyczno-Alergologiczny
Bialystok, Podlaskie Voivodeship, 15-010, Poland
Synexus Polska Sp. z o.o. Oddzial w Gdansku
Gdansk, Pomeranian Voivodeship, 80-382, Poland
Synexus Polska Sp. z o.o. Oddzial w Czestochowie
Częstochowa, Silesian Voivodeship, 42-202, Poland
Centrum Medyczne Wos i Piwowarczyk
Kraków, Łódź Voivodeship, 31-572, Poland
Synexus Polska Sp. Z o.o Oddzial w Lodzi
Lodz, Łódź Voivodeship, 90-127, Poland
Ostrowieckie Centrum Medyczne Spólka Cywilna Anna Olech-Cudzik, Krzysztof Cudzik
Ostrowiec Świętokrzyski, Świętokrzyskie Voivodeship, 27-400, Poland
Synexus Midlands Clinical Research Centre
Birmingham, England, B15 2SQ, United Kingdom
West Walk Surgery
Bristol, England, BS37 4AX, United Kingdom
MeDiNova Northamptonshire Quality Research Site
Corby, England, NN18 9EZ, United Kingdom
Castle Hill Hospital
Cottingham, England, HU16 5JQ, United Kingdom
MeDiNova Warwickshire Quality Research Site
Kenilworth, England, CV8 1JD, United Kingdom
Kings College Hospital
London, England, SE5 9RS, United Kingdom
Royal Brompton Hospital
London, England, SW3 6NP, United Kingdom
NW Consortium Manchester
Manchester, England, M15 6SX, United Kingdom
Wythenshawe Hospital - PPDS
Manchester, England, M23 9LT, United Kingdom
MeDiNova North London Quality Research Site
Middlesex, England, HA6 2RN, United Kingdom
North Tyneside General Hospital
North Shields, England, NE29 8NH, United Kingdom
MeDiNova East London Quality Research Site
Romford, England, RM1 3PJ, United Kingdom
MeDiNova Yorkshire Quality Research Site
Shipley, England, BD18 3SA, United Kingdom
MeDiNova South London Quality Research Site
Sidcup, England, DA14 6LT, United Kingdom
MeDiNova West London Quality Research Site
Wokingham, England, RG40 1XS, United Kingdom
Ormeau Clinical Trials Limited
Belfast, Northern Ireland, BT7 2EB, United Kingdom
Belfast City Hospital
Belfast, Northern Ireland, BT9 7AB, United Kingdom
AES - Synexus Scotland Clinical Research Centre
Glasgow, Scotland, G20 0SP, United Kingdom
Related Publications (1)
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.
PMID: 40043302DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 9, 2020
First Posted
December 21, 2020
Study Start
December 7, 2020
Primary Completion
October 21, 2021
Study Completion
November 2, 2021
Last Updated
December 13, 2021
Record last verified: 2021-12
Data Sharing
- IPD Sharing
- Will not share