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

Refractory Chronic Cough Clinical Trial

— SOOTHE  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04678206
• Other study ID #: BUS-P2-02
• Secondary ID: 2020-004136-17
• Status: Completed
• Phase: Phase 2
• Start date: December 7, 2020
• Est. completion date: November 2, 2021

Study information

• Verified date: December 2021
• Source: Bellus Health Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 310
• Est. completion date: November 2, 2021
• Est. primary completion date: October 21, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Cough
• Refractory Chronic Cough

Intervention

Drug:
• BLU-5937
Oral administration of BLU-5937 Tablets
• Placebo
Oral administration of matching placebo for BLU-5937 Tablets

Locations

Country	Name	City	State
Canada	McMaster University Medical Centre	Hamilton	Ontario
Canada	Clinique Spécialisée en Allergie de la Capitale	Québec	Quebec
Canada	Diex Recherche - Québec	Québec	Quebec
Canada	Inspiration Research Limited	Toronto	Quebec
Canada	C I C Maurice Inc	Trois-Rivières	Quebec
Canada	Diex Recherche - Victoriaville	Victoriaville	Quebec
Czechia	MUDr. I. Cierná Peterová s.r.o.	Brandýs Nad Labem-Stará Boleslav	Central Bohemia
Czechia	MediTrial s.r.o.	Jindrichuv Hradec	South Bohemia
Czechia	Pneumologie Varnsdorf S.r.o.	Nový Bor	Liberec
Czechia	Synexus Czech s.r.o.	Praha	Prague
Czechia	Plicní ambulance Rokycany s.r.o.	Rokycany	Plzen
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
Germany	Ärztezentrum Axel Springer Passage	Berlin
Germany	Universitätsklinikum Bonn	Bonn	Nordrhein-Westfalen
Germany	Klinische Forschung Dresden GmbH (KFGN)	Dresden	Sachsen
Germany	IKF Pneumologie	Frankfurt	Hessen
Germany	Synexus Frankfurt Research Centre	Frankfurt am main	Hessen
Germany	Thoraxklinik-Heidelberg gGmbH	Heidelberg	Baden-Württemberg
Germany	Synexus Leipzig Research Centre	Leipzig	Sachsen
Germany	Zentrum für ambulante pneumologische Forschung Marburg GbR	Marburg	Hessen
Germany	Ballenberger. Freytag. Wenisch - Institut fuer klinische Forschung GmbH	Neu Isenburg	Hessen
Germany	Kfns Klinische Forschung Schwerin	Schwerin	Mecklenburg-Vorpommern
Hungary	Dr. Kenessey Albert Korhaz-Rendelointezet	Balassagyarmat	Nógrád
Hungary	Synexus Budapest - Magyarország Egészségügyi Szolgáltató Kft	Budapest
Hungary	Synexus Gyula - Magyarország Egészségügyi Szolgáltató Kft	Gyula	Békés
Hungary	Da Vinci Maganklinika	Pécs	Baranya
Hungary	Szent Borbála Kórház	Tatabánya	Nograd
Hungary	Synexus Zalaegerszeg Magyarország Egészségügyi Kft	Zalaegerszeg	Zala
Poland	Prywatny Gabinet Internistyczno-Alergologiczny	Bialystok	Podlaskie
Poland	KLIMED	Bychawa	Lubelskie
Poland	Centrum Medyczne Bydgoszcz - PRATIA	Bydgoszcz	Kujawsko-pomorskie
Poland	Medical Center Kermed	Bydgoszcz	Kujawsko-pomorskie
Poland	Osrodek Badan Klinicznych CLINSANTE S.C. Ewa Galczak-Nowak Malgorzata Trzaska	Bydgoszcz	Kujawsko-pomorskie
Poland	Synexus Polska Sp. z o.o. Oddzial w Czestochowie	Czestochowa	Slaskie
Poland	Synexus Polska Sp. z o.o. Oddzial w Gdansku	Gdansk	Pomorskie
Poland	Centrum Medyczne Wos i Piwowarczyk	Kraków	Lódzkie
Poland	Synexus Polska Sp. Z o.o Oddzial w Lodzi	Lódz	Lodzkie
Poland	Centrum Alergologii Specjalistyczna Przychodnia Alergologiczna	Lublin	Lubelskie
Poland	Clinical Best Solutions -Lublin	Lublin	Lubelskie
Poland	Ostrowieckie Centrum Medyczne Spólka Cywilna Anna Olech-Cudzik, Krzysztof Cudzik	Ostrowiec Swietokrzyski	Swietokrzyskie
Poland	Alergo-Med Specjalistyczna Przychodnia Lekarska Sp. z.o.o	Tarnów	Malopolskie
Poland	Centrum Medyczne Warszawa - PRATIA	Warszawa	Mazowieckie
United Kingdom	Belfast City Hospital	Belfast	Northern Ireland
United Kingdom	Ormeau Clinical Trials Limited	Belfast	Northern Ireland
United Kingdom	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	AES - Synexus Scotland Clinical Research Centre	Glasgow	Scotland
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 States	Albuquerque Clinical Trials Inc	Albuquerque	New Mexico
United States	Clinical Research Associates Of Central Pa	Altoona	Pennsylvania
United States	Synexus Clinical Research US, Inc.	Anderson	South Carolina
United States	CHEAR Center LLC	Bronx	New York
United States	National Allergy and Asthma Research	Charleston	South Carolina
United States	American Health Research Inc	Charlotte	North Carolina
United States	The Lung Research Center, LLC	Chesterfield	Missouri
United States	Bernstein Clinical Research Center Inc	Cincinnati	Ohio
United States	St. Francis Medical Institute	Clearwater	Florida
United States	The Cleveland Clinic Foundation	Cleveland	Ohio
United States	University of Missouri, ENT and Allergy Center of Missouri	Columbia	Missouri
United States	IACT Health - Columbus	Columbus	Georgia
United States	Remington Davis Inc	Columbus	Ohio
United States	Pharmaceutical Research & Consulting Inc	Dallas	Texas
United States	Colorado Allergy and Asthma Centers	Denver	Colorado
United States	Intermountain Clinical Research	Draper	Utah
United States	Minnesota Lung Center	Edina	Minnesota
United States	El Paso Pulmonary Association	El Paso	Texas
United States	AES - Synexus Clinical Research US, Inc. - Evansville	Evansville	Indiana
United States	Abraham Research PLLC	Fort Mitchell	Kentucky
United States	Clinical Trials Center of Middle Tennessee	Franklin	Tennessee
United States	Clinical Research of Gastonia	Gastonia	North Carolina
United States	Floridian Clinical Research	Hialeah	Florida
United States	Sweet Hope Research Specialty, Inc.	Hialeah	Florida
United States	Village Research, LLC	Houston	Texas
United States	Sher Allergy Specialist/Center for Cough	Largo	Florida
United States	IACT Health - Lawrenceville	Lawrenceville	Georgia
United States	Medical Research of Central Florida	Leesburg	Florida
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	Metroplex Pulmonary and Sleep Medicine Center	McKinney	Texas
United States	ProCare Clinical Research	Miami Lakes	Florida
United States	Allergy and Asthma Associates of Southern California	Mission Viejo	California
United States	Montana Medical Research	Missoula	Montana
United States	Sneeze Wheeze and Itch Associates LLC	Normal	Illinois
United States	Infinity Medical Research Inc	North Dartmouth	Massachusetts
United States	California Medical Research Associates, Inc.	Northridge	California
United States	Creighton University Medical Center	Omaha	Nebraska
United States	Central Florida Pulmonary Group PA	Orlando	Florida
United States	Phoenix Medical Research Inc	Peoria	Arizona
United States	IACT Health - Rincon	Rincon	Georgia
United States	Mayo Clinic	Rochester	Minnesota
United States	Clinical Research of Rock Hill	Rock Hill	South Carolina
United States	The Clinical Research Center LLC	Saint Louis	Missouri
United States	Diagnostics Research Group	San Antonio	Texas
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	Sherman Clinical Research	Sherman	Texas
United States	Atlantic Respiratory Institute	Summit	New Jersey
United States	Lenus Research & Medical Group	Sweetwater	Florida
United States	Vital Prospects Clinical Research Institute PC	Tulsa	Oklahoma
United States	Allergy Asthma Research Institute	Waco	Texas
United States	TPMG Lung & Sleep Specialist	Williamsburg	Virginia
United States	Southeastern Research Center	Winston-Salem	North Carolina
United States	Minnesota Lung Center	Woodbury	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Bellus Health Inc

Countries where clinical trial is conducted

United States,  Canada,  Czechia,  Germany,  Hungary,  Poland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in the 24-hour cough frequency	Assessed using an ambulatory cough monitor	Week 4
Secondary	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
Secondary	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
Secondary	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
Secondary	Incidence (% of subjects) of treatment-emergent adverse events (TEAEs)		2 Weeks after the last study medication intake
Secondary	Severity (mild, moderate, or severe) of treatment-emergent adverse events (TEAEs)		2 Weeks after the last study medication intake