AzTrials
AzTrials

Refractory Chronic CoughPhase 2SOOTHENCT04678206

Evaluation of the Efficacy and Safety of BLU-5937 in Adults With Refractory Chronic Cough

A Phase 2 study testing BLU-5937 in people with Refractory Chronic Cough, run by Bellus Health Inc. - a GSK company at 116 sites in 7 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Refractory Chronic Cough
What is being tested?
BLU-5937
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
310 participants
Where
116 sitesin 7 countries
Study dates
7 Dec 2020to 2 Nov 2021
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

116 sites in 7 countries.

116 sites in 7 countries

United States55 sites

  • Albuquerque Clinical Trials Inc

    Albuquerque, New Mexico, 87102

  • Clinical Research Associates Of Central Pa

    Altoona, Pennsylvania, 16601

  • Synexus Clinical Research US, Inc.

    Anderson, South Carolina, 29621

  • National Allergy and Asthma Research

    Charleston, South Carolina, 29420

  • American Health Research Inc

    Charlotte, North Carolina, 28277

  • The Lung Research Center, LLC

    Chesterfield, Missouri, 63017

  • Bernstein Clinical Research Center Inc

    Cincinnati, Ohio, 45231

  • St. Francis Medical Institute

    Clearwater, Florida, 33765

  • The Cleveland Clinic Foundation

    Cleveland, Ohio, 44195

  • University of Missouri, ENT and Allergy Center of Missouri

    Columbia, Missouri, 65201

  • IACT Health - Columbus

    Columbus, Georgia, 31904

  • Remington Davis Inc

    Columbus, Ohio, 43215

  • Pharmaceutical Research & Consulting Inc

    Dallas, Texas, 75231

  • Colorado Allergy and Asthma Centers

    Denver, Colorado, 80230

  • Intermountain Clinical Research

    Draper, Utah, 84020

  • Minnesota Lung Center

    Edina, Minnesota, 55435

  • El Paso Pulmonary Association

    El Paso, Texas, 79902

  • AES - Synexus Clinical Research US, Inc. - Evansville

    Evansville, Indiana, 47714

  • Abraham Research PLLC

    Fort Mitchell, Kentucky, 41017

  • Clinical Trials Center of Middle Tennessee

    Franklin, Tennessee, 37067

  • Clinical Research of Gastonia

    Gastonia, North Carolina, 28054

  • Floridian Clinical Research

    Hialeah, Florida, 33016

  • Sweet Hope Research Specialty, Inc.

    Hialeah, Florida, 33016

  • Village Research, LLC

    Houston, Texas, 77084

  • Sher Allergy Specialist/Center for Cough

    Largo, Florida, 33778

  • IACT Health - Lawrenceville

    Lawrenceville, Georgia, 30046

  • Medical Research of Central Florida

    Leesburg, Florida, 34748

  • Little Rock Allergy and Asthma Clinical Research Center

    Little Rock, Arkansas, 21237

  • Southern California Institute For Respiratory Diseases, Inc

    Los Angeles, California, 90048

  • Metroplex Pulmonary and Sleep Medicine Center

    McKinney, Texas, 75069

  • ProCare Clinical Research

    Miami Lakes, Florida, 33014

  • Allergy and Asthma Associates of Southern California

    Mission Viejo, California, 92691

  • Montana Medical Research

    Missoula, Montana, 59808

  • Sneeze Wheeze and Itch Associates LLC

    Normal, Illinois, 61761

  • Infinity Medical Research Inc

    North Dartmouth, Massachusetts, 02747

  • California Medical Research Associates, Inc.

    Northridge, California, 91324

  • Creighton University Medical Center

    Omaha, Nebraska, 68124

  • Central Florida Pulmonary Group PA

    Orlando, Florida, 32803

  • Phoenix Medical Research Inc

    Peoria, Arizona, 85381

  • IACT Health - Rincon

    Rincon, Georgia, 31326

  • Mayo Clinic

    Rochester, Minnesota, 55905

  • Clinical Research of Rock Hill

    Rock Hill, South Carolina, 29732

  • Diagnostics Research Group

    San Antonio, Texas, 78229

  • Allergy Associates Medical Group Inc.

    San Diego, California, 92120

  • Allergy and Asthma Associates of Santa Clara Valley Research Center

    San Jose, California, 95117

  • Sherman Clinical Research

    Sherman, Texas, 75092

  • The Clinical Research Center LLC

    St Louis, Missouri, 63141

  • Atlantic Respiratory Institute

    Summit, New Jersey, 07901

  • Lenus Research & Medical Group

    Sweetwater, Florida, 33172

  • CHEAR Center LLC

    The Bronx, New York, 10455

  • Vital Prospects Clinical Research Institute PC

    Tulsa, Oklahoma, 74136

  • Allergy Asthma Research Institute

    Waco, Texas, 76712

  • TPMG Lung & Sleep Specialist

    Williamsburg, Virginia, 23188

  • Southeastern Research Center

    Winston-Salem, North Carolina, 27103

  • Minnesota Lung Center

    Woodbury, Minnesota, 55125

Other trials in United States

United Kingdom18 sites

  • Ormeau Clinical Trials Limited

    Belfast, Northern Ireland, BT7 2EB

  • Belfast City Hospital

    Belfast, Northern Ireland, BT9 7AB

  • Synexus Midlands Clinical Research Centre

    Birmingham, England, B15 2SQ

  • West Walk Surgery

    Bristol, England, BS37 4AX

  • MeDiNova Northamptonshire Quality Research Site

    Corby, England, NN18 9EZ

  • Castle Hill Hospital

    Cottingham, England, HU16 5JQ

  • AES - Synexus Scotland Clinical Research Centre

    Glasgow, Scotland, G20 0SP

  • MeDiNova Warwickshire Quality Research Site

    Kenilworth, England, CV8 1JD

  • Kings College Hospital

    London, England, SE5 9RS

  • Royal Brompton Hospital

    London, England, SW3 6NP

  • NW Consortium Manchester

    Manchester, England, M15 6SX

  • Wythenshawe Hospital - PPDS

    Manchester, England, M23 9LT

  • MeDiNova North London Quality Research Site

    Middlesex, England, HA6 2RN

  • North Tyneside General Hospital

    North Shields, England, NE29 8NH

  • MeDiNova East London Quality Research Site

    Romford, England, RM1 3PJ

  • MeDiNova Yorkshire Quality Research Site

    Shipley, England, BD18 3SA

  • MeDiNova South London Quality Research Site

    Sidcup, England, DA14 6LT

  • MeDiNova West London Quality Research Site

    Wokingham, England, RG40 1XS

Other trials in United Kingdom

Poland14 sites

  • Prywatny Gabinet Internistyczno-Alergologiczny

    Bialystok, Podlaskie Voivodeship, 15-010

  • KLIMED

    Bychawa, Lublin Voivodeship, 23-100

  • Osrodek Badan Klinicznych CLINSANTE S.C. Ewa Galczak-Nowak Malgorzata Trzaska

    Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 31-826

  • Medical Center Kermed

    Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-231

  • Centrum Medyczne Bydgoszcz - PRATIA

    Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-796

  • Synexus Polska Sp. z o.o. Oddzial w Czestochowie

    Częstochowa, Silesian Voivodeship, 42-202

  • Synexus Polska Sp. z o.o. Oddzial w Gdansku

    Gdansk, Pomeranian Voivodeship, 80-382

  • Centrum Medyczne Wos i Piwowarczyk

    Kraków, Łódź Voivodeship, 31-572

  • Synexus Polska Sp. Z o.o Oddzial w Lodzi

    Lodz, Łódź Voivodeship, 90-127

  • Clinical Best Solutions -Lublin

    Lublin, Lublin Voivodeship, 20-078

  • Centrum Alergologii Specjalistyczna Przychodnia Alergologiczna

    Lublin, Lublin Voivodeship, 20-552

  • Ostrowieckie Centrum Medyczne Spólka Cywilna Anna Olech-Cudzik, Krzysztof Cudzik

    Ostrowiec Świętokrzyski, Świętokrzyskie Voivodeship, 27-400

  • Alergo-Med Specjalistyczna Przychodnia Lekarska Sp. z.o.o

    Tarnów, Lesser Poland Voivodeship, 33-100

  • Centrum Medyczne Warszawa - PRATIA

    Warsaw, Masovian Voivodeship, 01-869

Other trials in Poland

Germany10 sites

  • Ärztezentrum Axel Springer Passage

    Berlin, 10969

  • Universitätsklinikum Bonn

    Bonn, North Rhine-Westphalia, 53127

  • Klinische Forschung Dresden GmbH (KFGN)

    Dresden, Saxony, 01069

  • Synexus Frankfurt Research Centre

    Frankfurt am Main, Hesse, 60313

  • IKF Pneumologie

    Frankfurt am Main, Hesse, 60596

  • Thoraxklinik-Heidelberg gGmbH

    Heidelberg, Baden-Wurttemberg, 69126

  • Synexus Leipzig Research Centre

    Leipzig, Saxony, 04103

  • Zentrum für ambulante pneumologische Forschung Marburg GbR

    Marburg, Hesse, 35037

  • Ballenberger. Freytag. Wenisch - Institut fuer klinische Forschung GmbH

    Neu-Isenburg, Hesse, 63263

  • Kfns Klinische Forschung Schwerin

    Schwerin, Mecklenburg-Vorpommern, 19055

Other trials in Germany

Czechia7 sites

  • MUDr. I. Cierná Peterová s.r.o.

    Brandýs nad Labem-Stará Boleslav, Central Bohemia, 250 01

  • MediTrial s.r.o.

    Jindřichův Hradec, South Bohemia, 377 01

  • Pneumologie Varnsdorf S.r.o.

    Nový Bor, Liberec, 473 01

  • Synexus Czech s.r.o.

    Prague, Prague, 120 00

  • Plicní ambulance Rokycany s.r.o.

    Rokycany, Plzeň, 33701

  • MUDr. Jaroslav Mares - odborny lekar pro obor tuberkulosa a respiracni nemoci

    Strakonice, South Bohemia, 386 01

  • Plicni stredisko Teplice s.r.o.

    Teplice, Ústí Nad Labem, 415 01

Other trials in Czechia

Canada6 sites

  • McMaster University Medical Centre

    Hamilton, Ontario, L8N 3Z5

  • Diex Recherche - Québec

    Québec, Quebec, G1N 4V3

  • Clinique Spécialisée en Allergie de la Capitale

    Québec, Quebec, G1V 4W2

  • Inspiration Research Limited

    Toronto, Quebec, M5T 3A9

  • C I C Maurice Inc

    Trois-Rivières, Quebec, G8T 7A1

  • Diex Recherche - Victoriaville

    Victoriaville, Quebec, G6P 6P6

Other trials in Canada

Hungary6 sites

  • Dr. Kenessey Albert Korhaz-Rendelointezet

    Balassagyarmat, Nógrád megye, 2660

  • Synexus Budapest - Magyarország Egészségügyi Szolgáltató Kft

    Budapest, 1036

  • Synexus Gyula - Magyarország Egészségügyi Szolgáltató Kft

    Gyula, Bekes County, 5700

  • Da Vinci Maganklinika

    Pécs, Baranya, 7635

  • Szent Borbála Kórház

    Tatabánya, Nógrád megye, 2800

  • Synexus Zalaegerszeg Magyarország Egészségügyi Kft

    Zalaegerszeg, Zala County, 8900

Other trials in Hungary

About this study

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

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).

Read the 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.

Being tested
BLU-5937, Placebo
Keywords
BLU-5937, Refractory Chronic Cough, P2X3 receptor antagonist
Medical subject headings
Chronic Cough

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BLU-5937Drug

    Oral administration of BLU-5937 Tablets

  • PlaceboDrug

    Oral administration of matching placebo for BLU-5937 Tablets

Study groups in NCT04678206
Study groupRoleWhat they receive
BLU-5937 Dose AExperimentalBLU-5937 oral dose A twice a day.
Receives: Drug: BLU-5937
BLU-5937 Dose BExperimentalBLU-5937 oral dose B twice a day.
Receives: Drug: BLU-5937
BLU-5937 Dose CExperimentalBLU-5937 oral dose C twice a day.
Receives: Drug: BLU-5937
PlaceboPlacebo comparatorMatching Placebo for BLU-5937 oral dose twice a day.
Receives: Drug: Placebo
BLU-5937 Dose A (Population with baseline cough < 25 coughs/hour)ExperimentalBLU-5937 oral dose A twice a day.
Receives: Drug: BLU-5937
Placebo (Population with baseline cough < 25 coughs/hour)Placebo comparatorMatching Placebo for BLU-5937 oral dose twice a day.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from baseline in the 24-hour cough frequency

    Assessed using an ambulatory cough monitor

    Measured: Week 4

Secondary outcomes (5)

  1. Percentage of Participants with a Reduction from Baseline in the 24-hour Cough Frequency by ≥ 30%, 50% and 70%

    Assessed using an ambulatory cough monitor

    Measured: Week 4

  2. Change from Baseline in Leicester Cough Questionnaire (LCQ)

    The LCQ is a patient-reported quality of life (QOL) measure of chronic cough. The questionnaire consists of 19 items to which the patient responds on a 7-point Likert response scale (from 1 to 7). Each item assesses symptoms during cough and the effect of cough on 3 main domains: physical, psychological and social. Domain scores range from 1-7, and the total score ranges from 3 - 21; a higher score indicates a better quality of life.

    Measured: Week 4

  3. Change from baseline in cough severity

    Assessed by Cough Severity Visual Analogue Scale [VAS] by the participant on a 100 mm visual analog scale where higher scores indicate worse severity.

    Measured: Week 4

  4. Incidence (% of subjects) of treatment-emergent adverse events (TEAEs)

    Measured: 2 Weeks after the last study medication intake

  5. Severity (mild, moderate, or severe) of treatment-emergent adverse events (TEAEs)

    Measured: 2 Weeks after the last study medication intake

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Dec 2020
  2. Study start7 Dec 2020
  3. Primary completion21 Oct 2021
  4. Study completion2 Nov 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Parallel Assignment
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
310 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04678206
Sponsor's protocol ID
BUS-P2-02
Other IDs
2020-004136-17
Acronym
SOOTHE
Status last verified
Dec 2021
First submitted
9 Dec 2020
Last updated
13 Dec 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 40043302

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing BLU-5937 in people with Refractory Chronic Cough, run by Bellus Health Inc. - a GSK company at 116 sites in 7 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 116 sites in United States, United Kingdom, Poland, Germany, Czechia and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline in the 24-hour cough frequency (time frame: Week 4). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04678206, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2021.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in