Refractory Chronic Cough Clinical Trial
— CALM-1Official title:
A Phase 3, 52-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel-Arm Efficacy and Safety Study With Open-Label Extension of BLU-5937 in Adult Participants With Refractory Chronic Cough, Including Unexplained Chronic Cough
This is a randomized, double-blind, placebo-controlled, parallel-arm, Phase 3 study of BLU-5937 in participants with Refractory Chronic Cough (RCC).
Status | Recruiting |
Enrollment | 825 |
Est. completion date | March 2026 |
Est. primary completion date | September 2025 |
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 |
Country | Name | City | State |
---|---|---|---|
Argentina | Expertia S.A- Mautalen Salud e Investigación | Ciudad Autonoma Buenos Aires | Buenos Aires |
Argentina | Hospital Italiano de Buenos Aires | Ciudad Autonoma Buenos Aires | |
Argentina | CINME - Centro De Investigaciones Metabolicas | Ciudad Autonoma de Buenos Aire | Buenos Aires |
Argentina | APRILLUS Asistencia e Investigacion | Ciudad Autonoma de Buenos Aires | Ciudad Autonoma Buenos Aires |
Argentina | Instituto Medico DAMIC | Cordoba | |
Argentina | Centro de Investigaciones Medicas Mar del Plata | Mar del Plata | Buenos Aires |
Argentina | Fundacion Scherbovsky | Mendoza | |
Argentina | Insares S.A. | Mendoza | |
Argentina | Instituto de Especialidades de la Salud Rosario | Rosario | Santa Fe |
Argentina | Instituto Medico de la Fundacion Estudios Clinicos | Rosario | Santa Fe |
Argentina | Instituto Medico Fundación Grupo Colaborativo Rosario Investigación y Prevención Medica | Rosario | Santa Fe |
Argentina | Instituto del Buen Aire | Santa Fe | |
Argentina | CEMER - Centro Medico de Enfermedades Respiratorias | Vicente López | Buenos Aires |
Belgium | Cliniques Universitaires Saint-Luc | Bruxelles | |
Belgium | Universitair Ziekenhuis Gent | Gent | |
Belgium | C. H. R. de la Citadelle | Liège | |
Belgium | AZ Sint-Maarten | Mechelen | |
Canada | Dynamic Drug Advancement | Ajax | Ontario |
Canada | Burlington Lung Clinic | Burlington | Ontario |
Canada | Peak Research Group | Calgary | Alberta |
Canada | University of Calgary - Health Sciences Centre | Calgary | Alberta |
Canada | CISSS de la Monteregie-Centre | Greenfield Park | Quebec |
Canada | Hamilton Medical Research Group | Hamilton | Ontario |
Canada | McMaster University Health Sciences Center | Hamilton | Ontario |
Canada | Kelowna Respirology and Asthma Research | Kelowna | British Columbia |
Canada | Montreal Chest Institute | Montréal | Quebec |
Canada | Recherche GCP Research | Montréal | |
Canada | Clinique Specialisee en Allergie de la Capitale | Québec | Quebec |
Canada | DIEX Recherche Quebec Inc. | Québec | Quebec |
Canada | Institut Universitaire de Cardiologie et de Pneumologie de Quebec | Québec | Quebec |
Canada | Clinique de pneumologie et du sommeil de Lanaudière | Saint-Charles-Borromée | Quebec |
Canada | Inspiration Research Limited | Toronto | Ontario |
Canada | CIC Mauricie Inc. | Trois-Rivières | Quebec |
Canada | DIEX Recherche Victoriaville Inc. | Victoriaville | Quebec |
Canada | Dr. Syed Anees Medicine Professional Corporation | Windsor | Ontario |
Colombia | Fundación Cardiovascular de Colombia - Instituto del Corazón Floridablanca | Floridablanca | |
Colombia | Asociacion IPS Medicos Internistas de Caldas | Manizales | |
Colombia | Clinica SOMER | Medellín | |
Colombia | Fundacion Centro de Investigacion Clinica CIC | Medellín | |
Colombia | Hospital Pablo Tobón Uribe | Medellín | |
France | CHU de Dijon - Hôpital François Mitterand | Dijon cedex | Côte-d'Or |
France | Hopital Albert Calmette CHU Lille | Lille | |
France | Hopital Européen de Marseille | Marseille | Bouches-du-Rhône |
France | Hôpital Nord - CHU Marseille | Marseille | Bouches-du-Rhône |
France | Hopital Arnaud de Villeneuve | Montpellier cedex 5 | Herault |
France | Hôpital Cochin | Paris | |
France | CHU de Strasbourg - Nouvel Hôpital Civil | Strasbourg | Bas Rhin |
France | Hopital Larrey | Toulouse | Haute Garonne |
Hungary | DRC Gyogyszervizsgalo Kozpont Kft. | Balatonfüred | |
Hungary | Clinexpert Kft. | Budapest | |
Hungary | Omnimodus Elixir Kft. | Csorna | |
Hungary | Erzsebet Gondozohaz Kft. | Gödöllo | |
Hungary | Szalay Janos Rendelointezet | Hajdunanas | |
Hungary | Da Vinci Maganklinika | Pécs | |
Hungary | Puspokladanyi Egeszsegugyi Szolgaltato Nonprofit Kft. | Püspökladány | |
India | Shetty Hospital | Bengaluru | Karnataka |
India | Institute of Medical Sciences and SUM Hospital | Bhubaneswar | Orissa |
India | Indraprastha Apollo Hospitals | Delhi | |
India | Asthma Bhavan | Jaipur | Rajasthan |
India | Calcutta Medical Research Institute | Kolkata | West Bengal |
India | Siddhi Hospital | Nashik | Maharashtra |
India | Suyog Multispeciality Hospital | Nashik | Maharashtra |
India | ACE Hospital and Research Centre | Pune | Masharashtra |
India | Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences | Rohtak | Haryana |
India | Bhaktivedanta Hospital and Research Institute | Thane | Maharashtra |
India | Aashirwad Hospital | Ulhasnagar | Maharashtra |
Israel | Hillel Yaffe Medical Center | Hadera | |
Israel | The Lady Davis Carmel Medical Center | Haifa | |
Israel | Hadassah University Hospital - Ein Kerem | Jerusalem | |
Israel | Rabin Medical Center-Beilinson Campus | Petach Tikva | |
Israel | Sheba Medical Center | Ramat Gan | |
Israel | Tel Aviv Sourasky Medical Center | Tel Aviv | |
Netherlands | Noordwest Ziekenhuisgroep | Alkmaar | |
Netherlands | Rijnstate | Arnhem | |
Netherlands | Amphia Ziekenhuis, Molengracht | Breda | |
Netherlands | Bernhoven Uden | Uden | |
Netherlands | Gelre Ziekenhuizen, Zutphen | Zutphen | |
Netherlands | Isala Klinieken, Weezenlanden | Zwolle | |
Poland | Prywatny Gabinet Internistyczno-Alergologiczny | Bialystok | |
Poland | Centrum Medyczne Pratia Bydgoszcz | Bydgoszcz | |
Poland | Uniwersytecki Szpital Kliniczny nr 1 im. N. Barlickiego w Lodzi | Lódz | |
Poland | Uniwersytecki Szpital Kliniczny nr 1 im. Norberta Barlickiego | Lódz | |
Poland | Ostrowieckie Centrum Medyczne spólka cywilna Anna Olech-Cudzik, Krzysztof Cudzik | Ostrowiec Swietokrzyski | |
Poland | Center of Innovative Therapies | Piaseczno | |
Poland | Prywatny Gabinet Lekarski | Rzeszów | |
Poland | Alergo-Med Specjalistyczna Przychodnia Lekarska Sp. Z .O.O. | Tarnów | |
Poland | Centrum Medyczne Lucyna Andrzej Dymek s.c. | Zawadzkie | |
South Africa | Iatros International | Bloemfontein | Free State |
South Africa | Dr NK Gounden Medi-Centre | Durban | KwaZulu-Natal |
South Africa | TASK Eden | George | Western Cape |
South Africa | Smith, C - Morningside Hospital | Johannesburg | Gauteng |
South Africa | Worthwhile Clinical Trials | Johannesburg | Gauteng |
South Africa | Botho ke Bontle Health Services | Pretoria | Gauteng |
South Africa | Global Clinical Trials | Pretoria | Gauteng |
South Africa | Dr JM Engelbrecht Trial Site | Somerset West | Western Cape |
Spain | Accellacare España SL | Alcobendas | Madrid |
Spain | Hospital Clinic de Barcelona | Barcelona | |
Spain | Hospital de la Santa Creu i Sant Pau | Barcelona | |
Spain | Hospital General Universitario Gregorio Marañon | Madrid | |
Spain | Hospital Universitario Clinico San Carlos | Madrid | |
Spain | Hospital Universitario de La Princesa | Madrid | |
Spain | Hospital Clinico Universitario Virgen de la Victoria | Málaga | |
Spain | Hospital Quironsalud Malaga | Málaga | |
Spain | Hospital Universitario Quironsalud Madrid | Pozuelo De Alarcón | Madrid |
Spain | Complejo Hospitalario Universitario de Santiago | Santiago De Compostela | La Coruña |
Turkey | Sureyyapasa Pulmonary Diseases and Cardiothoracic Surgery Education and Research Hospital | Istanbul | |
Turkey | Yedikule Pulmonary Dis. and Surgery Edu. and Res. Hosp. | Istanbul | |
Turkey | Ege University Medical Faculty | Izmir | |
Turkey | Kocaeli Universitesi - Kocaeli Universitesi Tip Fakultesi | Izmit | |
Turkey | Mersin University Medical Faculty | Mersin | |
Turkey | TC SBU Izmir Dr Suat Seren Gogus Hastaliklari ve Cerrahisi Egitim ve Arastirma | Yenisehir | |
United Kingdom | Belfast City Hospital | Belfast | |
United Kingdom | West Walk Surgery | Bristol | |
United Kingdom | Lakeside Healthcare | Corby | Northamptonshire |
United Kingdom | Holderness Health | Hull | East Riding Of Yorkshire |
United Kingdom | Royal Brompton Hospital | London | Greater London |
United Kingdom | Accellacare North London | Northwood | Middlesex |
United Kingdom | Norfolk and Norwich University Hospital | Norwich | Norfolk |
United Kingdom | Accellacare South London | Orpington | Kent |
United Kingdom | Accellacare Yorkshire | Shipley | Bedfordshire |
United Kingdom | Wythenshawe Hospital | Wythenshawe | Greater Manchester |
United States | McFarland Clinic P.C. | Ames | Iowa |
United States | Michigan Medicine Investigational Drug Services | Ann Arbor | Michigan |
United States | Care Access Research | Aurora | Colorado |
United States | The Asthma and Allergy Center | Bellevue | Nebraska |
United States | Bellingham Asthma, Allergy & Immunology Clinic | Bellingham | Washington |
United States | Accellacare Bristol | Bristol | Tennessee |
United States | Montefiore Medical Center (MMC) | Bronx | New York |
United States | Lowcountry Lung and Critical Care, P.A. | Charleston | South Carolina |
United States | American Health Research, Inc. | Charlotte | North Carolina |
United States | Innovative Research of West Florida, Inc. | Clearwater | Florida |
United States | The Curators of the University of Missouri on behalf of University of Missouri Health Care | Columbia | Missouri |
United States | Remington-Davis, Inc. | Columbus | Ohio |
United States | Avant Research Associates, LLC | Crowley | Louisiana |
United States | Pharmaceutical Research & Consulting, Inc. | Dallas | Texas |
United States | Omega Research Consultants | DeBary | Florida |
United States | PMG Research of DuPage Medical Group | Downers Grove | Illinois |
United States | Clinical Research Associates of Central PA, LLC | DuBois | Pennsylvania |
United States | Warren W. Pleskow, MD, 1071572 | Encinitas | California |
United States | North Florida Foundation for Research and Education, Inc. | Gainesville | Florida |
United States | The Community Research of South Florida | Hialeah | Florida |
United States | Clinical Trial Network LLC | Houston | Texas |
United States | University of Texas Health Science Center at Houston | Houston | Texas |
United States | University of Iowa Hospitals & Clinics | Iowa City | Iowa |
United States | Jasper Summit Research, LLC | Jasper | Alabama |
United States | University of Kansas Medical Center Research Institute, Inc. | Kansas City | Kansas |
United States | PMG Research of Knoxville | Knoxville | Tennessee |
United States | Sher Allergy | Largo | Florida |
United States | Gwinnett Pulmonary Group P.C. | Lawrenceville | Georgia |
United States | Research Solutions of Arizona, PC | Litchfield Park | Arizona |
United States | Main Street Physician's Care - Waterway | Little River | South Carolina |
United States | Little Rock Allergy & Asthma, P.A. Clinical Research Center | Little Rock | Arkansas |
United States | Metroplex Pulmonary and Sleep Center | McKinney | Texas |
United States | Velocity Clinical Research | Medford | Oregon |
United States | Coral Research Clinic corp | Miami | Florida |
United States | Cordova Research Institute, LLC | Miami | Florida |
United States | Life Spring Research Foundation | Miami | Florida |
United States | Well Pharma Medical Research Corporation | Miami | Florida |
United States | Allergy & Asthma Research of Southern California | Mission Viejo | California |
United States | Montana Medical Research, Inc. | Missoula | Montana |
United States | PMG Research of Charleston, LLC | Mount Pleasant | South Carolina |
United States | Eastern Virginia Medical School | Norfolk | Virginia |
United States | Sneeze, Wheeze and Itch Associates, LLC | Normal | Illinois |
United States | Infinity Medical Research Inc | North Dartmouth | Massachusetts |
United States | University of Oklahoma Health Sciences Center | Oklahoma City | Oklahoma |
United States | Center for Clinical Trials, LLC | Paramount | California |
United States | Temple Lung Center | Philadelphia | Pennsylvania |
United States | Allergy Associates Research Center | Portland | Oregon |
United States | PMG Research of Raleigh | Raleigh | North Carolina |
United States | Clinical Research of Rock Hill | Rock Hill | South Carolina |
United States | PMG Research of Rocky Mount, LLC | Rocky Mount | North Carolina |
United States | PMG Research of Salisbury, LLC | Salisbury | North Carolina |
United States | University of Utah Hospitals & Clinics | Salt Lake City | Utah |
United States | Diagnostics Research Group, LLC | San Antonio | Texas |
United States | Allergy Associates Medical Group, Inc. | San Diego | California |
United States | Medical Research of Arizona | Scottsdale | Arizona |
United States | Cotton O'Neil Clinical Research Center | Topeka | Kansas |
United States | Vital Prospects Clinical Research Institute, P.C. | Tulsa | Oklahoma |
United States | Allergy Asthma Research Institute | Waco | Texas |
United States | AAPRI Clinical Research Institute | Warwick | Rhode Island |
United States | University of Kansas Medical Center Research Institute, Inc. | Wichita | Kansas |
United States | TPMG Clinical Research Williamsburg | Williamsburg | Virginia |
United States | Southeastern Research Center LLC | Winston-Salem | North Carolina |
Lead Sponsor | Collaborator |
---|---|
Bellus Health Inc. - a GSK company |
United States, Argentina, Belgium, Canada, Colombia, France, Hungary, India, Israel, Netherlands, Poland, South Africa, Spain, Turkey, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 24-Hour Cough Frequency | Assessed using an ambulatory cough monitor | Week 12 | |
Secondary | Change from Baseline in Cough Severity Visual Analogue Scale at Week 12 | Assessed by Cough Severity Visual Analogue Scale [VAS] by the participant on a 100 mm visual analog scale where higher scores indicate greater severity. | Baseline, Week 12 | |
Secondary | Percentage of Participants With = 30mm Reduction, = 20mm Reduction From Baseline in Cough Severity Visual Analog Scale (VAS) at Week 12 | Assessed by Cough Severity Visual Analogue Scale [VAS] by the participant on a 100 mm visual analog scale where higher scores indicate greater severity. | Baseline, Week 12 | |
Secondary | Percentage of Participants With =30%, =50%, and =70% Reduction From Baseline in 24-Hour Cough Frequency at Week 12 | Assessed using an ambulatory cough monitor | Baseline, Week 12 | |
Secondary | Change from Baseline in the Leicester Cough Questionnaire (LCQ) Total Score at Week 12 | 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 impact of cough on 3 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. | Baseline, Week 12 | |
Secondary | Percentage of Participants With a =1.3-point Increase From Baseline in Leicester Cough Questionnaire (LCQ) Total Score at Week 12 | 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 impact of cough on 3 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. | Baseline, Week 12 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03282591 -
Study of the Efficacy, Safety, and Tolerability of Serlopitant for the Treatment of Refractory Chronic Cough
|
Phase 2 | |
Completed |
NCT03407014 -
Effect of Gefapixant (MK-7264/AF-219) on Cough Reflex Sensitivity in Healthy and Chronic Cough Participants (MK-7264-014)
|
Phase 2 | |
Completed |
NCT02476890 -
Effect of Gefapixant (MK-7264/AF-219) on Cough Reflex Sensitivity in Healthy and Chronic Cough Participants (MK-7264-014)
|
Phase 2 | |
Recruiting |
NCT03662269 -
Indomethacin for Refractory Chronic Cough
|
Phase 3 | |
Recruiting |
NCT05962151 -
Refractory Chronic Cough Improvement Via NAL ER (RIVER)
|
Phase 2 | |
Recruiting |
NCT05110144 -
Efficacy of Two Doses of Duloxetine and Amitriptyline in Subjects With Refractory Chronic Cough
|
Phase 2 | |
Active, not recruiting |
NCT04882943 -
COllaboration REsearch on Chronic Cough (COREC): a French Multicenter Database
|
||
Enrolling by invitation |
NCT05733533 -
A Study to Assess the Efficacy and Tolerance of HRS-2261 in Subjects With Refractory Chronic Cough
|
Phase 2 | |
Completed |
NCT02349425 -
A Dose Escalation Study of Gefapixant (AF-219/MK-7264) in Refractory Chronic Cough (MK-7264-010)
|
Phase 2 | |
Recruiting |
NCT05600777 -
A 24-Week Study of the Efficacy and Safety of BLU-5937 in Adults With Refractory Chronic Cough (CALM-2)
|
Phase 3 | |
Completed |
NCT05628740 -
Placebo-controlled, Single and Multiple Dose Study in Healthy Volunteers and Refractory Chronic Cough Patients to Assess the Safety, Tolerability, and Pharmacokinetics of Two Formulations of NTX-1175
|
Phase 1 | |
Not yet recruiting |
NCT06213363 -
A Phase Ib/II Clinical Study in Patients With Refractory Chronic Cough
|
Phase 1/Phase 2 | |
Completed |
NCT02412020 -
Treatment of Refractory Chronic Cough With PA101
|
Phase 2 | |
Completed |
NCT04678206 -
Evaluation of the Efficacy and Safety of BLU-5937 in Adults With Refractory Chronic Cough
|
Phase 2 | |
Completed |
NCT02612623 -
An 8-Week Refractory Chronic Cough Study (MK-7264-021)
|
Phase 2 | |
Completed |
NCT02612610 -
A 12-Week Study in Participants With Refractory Chronic Cough (MK-7264-012)
|
Phase 2 | |
Completed |
NCT02397460 -
Effect of Gefapixant (AF-219/MK-7264) on Cough Reflex Sensitivity (MK-7264-015)
|
Phase 2 | |
Not yet recruiting |
NCT05265871 -
ATP Level and Cough Sensitivity to ATP in Subjects With Refractory Chronic Cough
|