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

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).

Study Overview

• Status: Completed
• Conditions: Refractory Chronic Cough
• Intervention / Treatment: Drug: BLU-5937; Drug: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 310
• Phase: Phase 2

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Hamilton, Ontario, Canada, L8N 3Z5
      • McMaster University Medical Centre
  • Quebec
    • Québec, Quebec, Canada, G1N 4V3
      • Diex Recherche - Québec
    • Québec, Quebec, Canada, G1V 4W2
      • Clinique Specialisee en Allergie de la Capitale
    • Toronto, Quebec, Canada, M5T 3A9
      • Inspiration Research Limited
    • Trois-Rivières, Quebec, Canada, G8T 7A1
      • C I C Maurice Inc
    • Victoriaville, Quebec, Canada, G6P 6P6
      • Diex Recherche - Victoriaville
• Czechia
  • Central Bohemia
    • Brandýs Nad Labem-Stará Boleslav, Central Bohemia, Czechia, 250 01
      • MUDr. I. Cierna Peterova s.r.o.
  • Liberec
    • Nový Bor, Liberec, Czechia, 473 01
      • Pneumologie Varnsdorf S.r.o.
  • Plzeň
    • Rokycany, Plzeň, Czechia, 33701
      • Plicní Ambulance Rokycany s.r.o.
  • Prague
    • Praha, Prague, Czechia, 120 00
      • Synexus Czech s.r.o.
  • South Bohemia
    • Jindřichův Hradec, South Bohemia, Czechia, 377 01
      • MediTrial s.r.o.
    • Strakonice, South Bohemia, Czechia, 386 01
      • MUDr. Jaroslav Mares - odborny lekar pro obor tuberkulosa a respiracni nemoci
  • Ústí Nad Labem
    • Teplice, Ústí Nad Labem, Czechia, 415 01
      • Plicni stredisko Teplice s.r.o.
• Germany
  • Berlin, Germany, 10969
    • Ärztezentrum Axel Springer Passage
  • Baden-Württemberg
    • Heidelberg, Baden-Württemberg, Germany, 69126
      • Thoraxklinik-Heidelberg gGmbH
  • Hessen
    • Frankfurt, Hessen, Germany, 60596
      • IKF Pneumologie
    • Frankfurt am main, Hessen, Germany, 60313
      • Synexus Frankfurt Research Centre
    • Marburg, Hessen, Germany, 35037
      • Zentrum für ambulante pneumologische Forschung Marburg GbR
    • Neu Isenburg, Hessen, Germany, 63263
      • Ballenberger. Freytag. Wenisch - Institut fuer klinische Forschung GmbH
  • Mecklenburg-Vorpommern
    • Schwerin, Mecklenburg-Vorpommern, Germany, 19055
      • Kfns Klinische Forschung Schwerin
  • Nordrhein-Westfalen
    • Bonn, Nordrhein-Westfalen, Germany, 53127
      • Universitatsklinikum Bonn
  • Sachsen
    • Dresden, Sachsen, Germany, 01069
      • Klinische Forschung Dresden GmbH (KFGN)
    • Leipzig, Sachsen, Germany, 04103
      • Synexus Leipzig Research Centre
• Hungary
  • Budapest, Hungary, 1036
    • Synexus Budapest - Magyarország Egészségügyi Szolgáltató Kft
  • Baranya
    • Pécs, Baranya, Hungary, 7635
      • Da Vinci Maganklinika
  • Békés
    • Gyula, Békés, Hungary, 5700
      • Synexus Gyula - Magyarország Egészségügyi Szolgáltató Kft
  • Nograd
    • Tatabánya, Nograd, Hungary, 2800
      • Szent Borbala Korhaz
  • Nógrád
    • Balassagyarmat, Nógrád, Hungary, 2660
      • Dr. Kenessey Albert Korhaz-Rendelointezet
  • Zala
    • Zalaegerszeg, Zala, Hungary, 8900
      • Synexus Zalaegerszeg Magyarország Egészségügyi Kft
• Poland
  • Kujawsko-pomorskie
    • Bydgoszcz, Kujawsko-pomorskie, Poland, 31-826
      • Osrodek Badan Klinicznych CLINSANTE S.C. Ewa Galczak-Nowak Malgorzata Trzaska
    • Bydgoszcz, Kujawsko-pomorskie, Poland, 85-231
      • Medical Center Kermed
    • Bydgoszcz, Kujawsko-pomorskie, Poland, 85-796
      • Centrum Medyczne Bydgoszcz - PRATIA
  • Lodzkie
    • Łódź, Lodzkie, Poland, 90-127
      • Synexus Polska Sp. Z o.o Oddzial w Lodzi
  • Lubelskie
    • Bychawa, Lubelskie, Poland, 23-100
      • KLIMED
    • Lublin, Lubelskie, Poland, 20-078
      • Clinical Best Solutions -Lublin
    • Lublin, Lubelskie, Poland, 20-552
      • Centrum Alergologii Specjalistyczna Przychodnia Alergologiczna
  • Mazowieckie
    • Warszawa, Mazowieckie, Poland, 01-869
      • Centrum Medyczne Warszawa - PRATIA
  • Małopolskie
    • Tarnów, Małopolskie, Poland, 33-100
      • ALERGO-MED Specjalistyczna Przychodnia Lekarska Sp. z.o.o
  • Podlaskie
    • Białystok, Podlaskie, Poland, 15-010
      • Prywatny Gabinet Internistyczno-Alergologiczny
  • Pomorskie
    • Gdansk, Pomorskie, Poland, 80-382
      • Synexus Polska Sp. z o.o. Oddzial w Gdansku
  • Łódzkie
    • Kraków, Łódzkie, Poland, 31-572
      • Centrum Medyczne Wos i Piwowarczyk
  • Śląskie
    • Częstochowa, Śląskie, Poland, 42-202
      • Synexus Polska Sp. z o.o. Oddzial w Czestochowie
  • Świętokrzyskie
    • Ostrowiec Świętokrzyski, Świętokrzyskie, Poland, 27-400
      • Ostrowieckie Centrum Medyczne Spolka Cywilna Anna Olech-Cudzik, Krzysztof Cudzik
• United Kingdom
  • England
    • Birmingham, England, United Kingdom, B15 2SQ
      • Synexus Midlands Clinical Research Centre
    • Bristol, England, United Kingdom, BS37 4AX
      • West Walk Surgery
    • Corby, England, United Kingdom, NN18 9EZ
      • MeDiNova Northamptonshire Quality Research Site
    • Cottingham, England, United Kingdom, HU16 5JQ
      • Castle Hill Hospital
    • Kenilworth, England, United Kingdom, CV8 1JD
      • MeDiNova Warwickshire Quality Research Site
    • London, England, United Kingdom, SE5 9RS
      • Kings College Hospital
    • London, England, United Kingdom, SW3 6NP
      • Royal Brompton Hospital
    • Manchester, England, United Kingdom, M15 6SX
      • NW Consortium Manchester
    • Manchester, England, United Kingdom, M23 9LT
      • Wythenshawe Hospital - PPDS
    • Middlesex, England, United Kingdom, HA6 2RN
      • MeDiNova North London Quality Research Site
    • North Shields, England, United Kingdom, NE29 8NH
      • North Tyneside General Hospital
    • Romford, England, United Kingdom, RM1 3PJ
      • MeDiNova East London Quality Research Site
    • Shipley, England, United Kingdom, BD18 3SA
      • Medinova Yorkshire Quality Research Site
    • Sidcup, England, United Kingdom, DA14 6LT
      • MeDiNova South London Quality Research Site
    • Wokingham, England, United Kingdom, RG40 1XS
      • MeDiNova West London Quality Research Site
  • Northern Ireland
    • Belfast, Northern Ireland, United Kingdom, BT7 2EB
      • Ormeau Clinical Trials Limited
    • Belfast, Northern Ireland, United Kingdom, BT9 7AB
      • Belfast City Hospital
  • Scotland
    • Glasgow, Scotland, United Kingdom, G20 0SP
      • AES - Synexus Scotland Clinical Research Centre
• United States
  • Arizona
    • Peoria, Arizona, United States, 85381
      • Phoenix Medical Research Inc
  • Arkansas
    • Little Rock, Arkansas, United States, 21237
      • Little Rock Allergy and Asthma Clinical Research Center
  • California
    • Los Angeles, California, United States, 90048
      • Southern California Institute For Respiratory Diseases, Inc
    • Mission Viejo, California, United States, 92691
      • Allergy and Asthma Associates of Southern California
    • Northridge, California, United States, 91324
      • California Medical Research Associates, Inc.
    • San Diego, California, United States, 92120
      • Allergy Associates Medical Group Inc.
    • San Jose, California, United States, 95117
      • Allergy and Asthma Associates of Santa Clara Valley Research Center
  • Colorado
    • Denver, Colorado, United States, 80230
      • Colorado Allergy and Asthma Centers
  • Florida
    • Clearwater, Florida, United States, 33765
      • St. Francis Medical Institute
    • Hialeah, Florida, United States, 33016
      • Floridian Clinical Research
    • Hialeah, Florida, United States, 33016
      • Sweet Hope Research Specialty, Inc.
    • Largo, Florida, United States, 33778
      • Sher Allergy Specialist/Center for Cough
    • Leesburg, Florida, United States, 34748
      • Medical Research of Central Florida
    • Miami Lakes, Florida, United States, 33014
      • ProCare Clinical Research
    • Orlando, Florida, United States, 32803
      • Central Florida Pulmonary Group PA
    • Sweetwater, Florida, United States, 33172
      • Lenus Research & Medical Group
  • Georgia
    • Columbus, Georgia, United States, 31904
      • IACT Health - Columbus
    • Lawrenceville, Georgia, United States, 30046
      • IACT Health - Lawrenceville
    • Rincon, Georgia, United States, 31326
      • IACT Health - Rincon
  • Illinois
    • Normal, Illinois, United States, 61761
      • Sneeze Wheeze and Itch Associates Llc
  • Indiana
    • Evansville, Indiana, United States, 47714
      • AES - Synexus Clinical Research US, Inc. - Evansville
  • Kentucky
    • Fort Mitchell, Kentucky, United States, 41017
      • Abraham Research PLLC
  • Massachusetts
    • North Dartmouth, Massachusetts, United States, 02747
      • Infinity Medical Research Inc
  • Minnesota
    • Edina, Minnesota, United States, 55435
      • Minnesota Lung Center
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic
    • Woodbury, Minnesota, United States, 55125
      • Minnesota Lung Center
  • Missouri
    • Chesterfield, Missouri, United States, 63017
      • The Lung Research Center, LLC
    • Columbia, Missouri, United States, 65201
      • University of Missouri, ENT and Allergy Center of Missouri
    • Saint Louis, Missouri, United States, 63141
      • The Clinical Research Center LLC
  • Montana
    • Missoula, Montana, United States, 59808
      • Montana Medical Research
  • Nebraska
    • Omaha, Nebraska, United States, 68124
      • Creighton University Medical Center
  • New Jersey
    • Summit, New Jersey, United States, 07901
      • Atlantic Respiratory Institute
  • New Mexico
    • Albuquerque, New Mexico, United States, 87102
      • Albuquerque Clinical Trials Inc
  • New York
    • Bronx, New York, United States, 10455
      • Chear Center LLC
  • North Carolina
    • Charlotte, North Carolina, United States, 28277
      • American Health Research Inc
    • Gastonia, North Carolina, United States, 28054
      • Clinical Research of Gastonia
    • Winston-Salem, North Carolina, United States, 27103
      • Southeastern Research Center
  • Ohio
    • Cincinnati, Ohio, United States, 45231
      • Bernstein Clinical Research Center Inc
    • Cleveland, Ohio, United States, 44195
      • The Cleveland Clinic Foundation
    • Columbus, Ohio, United States, 43215
      • Remington Davis Inc
  • Oklahoma
    • Tulsa, Oklahoma, United States, 74136
      • Vital Prospects Clinical Research Institute PC
  • Pennsylvania
    • Altoona, Pennsylvania, United States, 16601
      • Clinical Research Associates of Central PA
  • South Carolina
    • Anderson, South Carolina, United States, 29621
      • Synexus Clinical Research US, Inc.
    • Charleston, South Carolina, United States, 29420
      • National Allergy and Asthma Research
    • Rock Hill, South Carolina, United States, 29732
      • Clinical Research of Rock Hill
  • Tennessee
    • Franklin, Tennessee, United States, 37067
      • Clinical Trials Center of Middle Tennessee
  • Texas
    • Dallas, Texas, United States, 75231
      • Pharmaceutical Research & Consulting Inc
    • El Paso, Texas, United States, 79902
      • El Paso Pulmonary Association
    • Houston, Texas, United States, 77084
      • Village Research, LLC
    • McKinney, Texas, United States, 75069
      • Metroplex Pulmonary and Sleep Medicine Center
    • San Antonio, Texas, United States, 78229
      • Diagnostics Research Group
    • Sherman, Texas, United States, 75092
      • Sherman Clinical Research
    • Waco, Texas, United States, 76712
      • Allergy Asthma Research Institute
  • Utah
    • Draper, Utah, United States, 84020
      • Intermountain Clinical Research
  • Virginia
    • Williamsburg, Virginia, United States, 23188
      • TPMG Lung & Sleep Specialist

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Matching Placebo for BLU-5937 oral dose twice a day.	Drug: Placebo; Oral administration of matching placebo for BLU-5937 Tablets
Experimental: BLU-5937 Dose A; BLU-5937 oral dose A twice a day.	Drug: BLU-5937; Oral administration of BLU-5937 Tablets
Experimental: BLU-5937 Dose B; BLU-5937 oral dose B twice a day.	Drug: BLU-5937; Oral administration of BLU-5937 Tablets
Experimental: BLU-5937 Dose C; BLU-5937 oral dose C twice a day.	Drug: BLU-5937; Oral administration of BLU-5937 Tablets
Experimental: BLU-5937 Dose A (Population with baseline cough < 25 coughs/hour); BLU-5937 oral dose A twice a day.	Drug: BLU-5937; Oral administration of BLU-5937 Tablets
Placebo Comparator: Placebo (Population with baseline cough < 25 coughs/hour); Matching Placebo for BLU-5937 oral dose twice a day.	Drug: Placebo; Oral administration of matching placebo for BLU-5937 Tablets

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in the 24-hour cough frequency	Assessed using an ambulatory cough monitor	Week 4

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Week 4
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.	Week 4
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.	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

Collaborators and Investigators

• Sponsor: Bellus Health Inc

Study record dates

Study Major Dates

• Study Start (Actual): December 7, 2020
• Primary Completion (Actual): October 21, 2021
• Study Completion (Actual): November 2, 2021

Study Registration Dates

• First Submitted: December 9, 2020
• First Submitted That Met QC Criteria: December 18, 2020
• First Posted (Actual): December 21, 2020

Study Record Updates

• Last Update Posted (Actual): December 13, 2021
• Last Update Submitted That Met QC Criteria: December 10, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: BLU-5937; Refractory Chronic Cough; P2X3 receptor antagonist
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Cough
• Other Study ID Numbers: BUS-P2-02; 2020-004136-17 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No