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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-004136-17 | EudraCT Number |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BLU-5937 Dose A | Experimental | BLU-5937 oral dose A twice a day. |
|
| BLU-5937 Dose B | Experimental | BLU-5937 oral dose B twice a day. |
|
| BLU-5937 Dose C | Experimental | BLU-5937 oral dose C twice a day. |
|
| Placebo | Placebo Comparator | Matching Placebo for BLU-5937 oral dose twice a day. |
|
| BLU-5937 Dose A (Population with baseline cough < 25 coughs/hour) | Experimental | BLU-5937 oral dose A twice a day. |
|
| Placebo (Population with baseline cough < 25 coughs/hour) | Placebo Comparator | Matching Placebo for BLU-5937 oral dose twice a day. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BLU-5937 | Drug | Oral administration of BLU-5937 Tablets |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in the 24-hour cough frequency | Assessed using an ambulatory cough monitor | Week 4 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Phoenix Medical Research Inc | Peoria | Arizona | 85381 | United States | ||
| Little Rock Allergy and Asthma Clinical Research Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40043302 | Derived | 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. |
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Parallel Assignment
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| Placebo | Drug | Oral administration of matching placebo for BLU-5937 Tablets |
|
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 |
| 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 |
| ID | Term |
|---|---|
| D000096822 | Chronic Cough |
| ID | Term |
|---|---|
| D003371 | Cough |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C000657411 | BLU-5937 |
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