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| Name | Class |
|---|---|
| IQVIA Pty Ltd | INDUSTRY |
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This is a phase 2b, randomized, double-blind, placebo-controlled study investigating the efficacy, safety, and tolerability of Taplucainium Inhalation Powder (NOC-110) once daily in adults with refractory or unexplained chronic cough.
Approximately 455 participants will take part in the study. It is anticipated that up to 1264 participants will be screened. Participation will be approximately 13 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NOC-110 1mg | Experimental | NOC-110 (taplucainium) administered by daily dry powder inhalation. NOC-110 contains a dry powder lactose blend containing drug substance taplucainium administered using an available inhaler. |
|
| NOC-110 3mg | Experimental | NOC-110 (taplucainium) administered by daily dry powder inhalation. NOC-110 contains a dry powder lactose blend containing drug substance taplucainium administered using an available inhaler. |
|
| NOC-110 6mg | Experimental | NOC-110 (taplucainium) administered by daily dry powder inhalation. NOC-110 contains a dry powder lactose blend containing drug substance taplucainium administered using an available inhaler. |
|
| Placebo | Placebo Comparator | The matching placebo contains inhalation grade lactose blended with arginine. The blend is taste masked to the active drug product to minimize unblinding due to taste differences. The matching placebo will be administered via the same inhaler. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NOC-110 | Drug | Inhalation powder |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in 24-hour Coughs per hour from Baseline | Change in 24-hour Coughs per hour from Baseline will be based on VitaloJAK® Cough Counts. The VitaloJAK® is a 510(k)-cleared medical device consisting of a digital sound recorder with 2 microphones; a lapel air microphone attached to the participant's clothing and an adhesive chest wall microphone which is attached to the skin at the top of the sternum. | Baseline to End of Treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Awake coughs per hour from Baseline | Change in Awake coughs per hour from Baseline will be based on VitaloJAK® Cough Counts. The VitaloJAK® is a 510(k)-cleared medical device consisting of a digital sound recorder with 2 microphones; a lapel air microphone attached to the participant's clothing and an adhesive chest wall microphone which is attached to the skin at the top of the sternum. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in 24-hour and awake coughs per hour from Baseline with the Hyfe CoughMonitor System | Change in 24-hour and awake coughs per hour from Baseline will be based on Hyfe CoughMonitor System cough counts. The Hyfe CoughMonitor Suite is an end-to-end system for continuous, objective cough monitoring in clinical trials. It has been rigorously validated and has been submitted (de novo) in 2023 to the FDA. The system consists of a mic-equipped wrist-worn watch (current recommended model is Shenzhen DO Intelligent Technology Co. ID206) running the Hyfe Cough-Monitor smartwatch app. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Matthew Frankel, MD | Chief Medical Officer Nocion Therapeutics, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| G & L Research, LLC | Foley | Alabama | 36535 | United States | ||
| Medical Research of Arizona |
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| Placebo | Other | Inhalation powder |
|
| Baseline to End of Treatment |
| Change in the Cough Severity Visual Analog Scale from Baseline | Visual Analogue Scales for Cough Severity (CS-VAS) will be performed as outlined in the Schedule of Assessments. Participants rate the severity of their cough by marking on the horizontal line their cough severity, with the extreme left side of the line represents "no cough" and the extreme right side of the line representing "worst cough." | Baseline to End of Treatment |
| Change in the Urge to Cough Visual Analog Scale from Baseline | Urge to Cough Analogue Scales for Cough Severity (UC-VAS) will be performed as outlined in the Schedule of Assessments. Participants rate the severity of their cough by marking on the horizontal line their cough severity, with the extreme left side of the line represents "no cough" and the extreme right side of the line representing "worst cough." | Baseline to End of Treatment |
| Change in the Leicester Cough Questionnaire from Baseline | Leicester Cough Questionnaire (LCQ) is a validated cough-specific quality of life measure that evaluates the impact of cough across 3 domains: physical, psychological, and social. The LCQ is a 19-item questionnaire with each item scored using a 7-point Likert scale ranging from 1 = all the time to 7=none of the time. The total severity score ranges from 3-21, with a lower score indicating greater impairment of health status due to cough. | Baseline to End of Treatment |
| Patient Global Impressions of Improvement score | Patient Global Impressions of Improvement (PGI-I) is used to assess improvement or worsening of the Participants status in relation to the therapeutic area of interest. The main purpose of the scale is to quantify the extent to which the participant has improved or deteriorated over time. The PGI-I is a 7-point Likert scale ranging from 1=Very Much Better to 7=Very Much Worse. | End of Treatment |
| Incidence and severity of adverse events and serious adverse events | Baseline to End of Treatment |
| Baseline to End of Treatment |
| Scottsdale |
| Arizona |
| 85251 |
| United States |
| AMR Phoenix | Tempe | Arizona | 85281 | United States |
| Little Rock Allergy & Asthma, P.A. Clinical Research Center | Little Rock | Arkansas | 72205 | United States |
| So Cal Clinical Research | Huntington Beach | California | 92647 | United States |
| Allergy and Asthma Associates of Southern California dba Southern California Research | Laguna Niguel | California | 92677 | United States |
| Paradigm Clinical Research Centers, LLC - Modesto | Modesto | California | 95355 | United States |
| NewportNativeMD,Inc | Newport Beach | California | 92663 | United States |
| Center for Clinical Trials, LLC | Paramount | California | 90723 | United States |
| Paradigm Clinical Research Centers, LLC | Redding | California | 96001 | United States |
| DaVinci Research LLC. | Roseville | California | 95661 | United States |
| Allergy & Asthma Associates of Santa Clara Valley | San Jose | California | 95117 | United States |
| California Allergy & Asthma Medical Group Inc. | San Jose | California | 95117 | United States |
| Allergy, Asthma, and Immunology Medical Group | Ventura | California | 93003 | United States |
| Allergy and Asthma Clinical Research Inc | Walnut Creek | California | 94598 | United States |
| Lynn Institute of Denver | Aurora | Colorado | 80012 | United States |
| Innovative Research of West Florida, Inc. | Clearwater | Florida | 33756 | United States |
| Omega Research Debary, LLC | DeBary | Florida | 32713 | United States |
| Jacksonville Center for Clinical Research | Jacksonville | Florida | 32216 | United States |
| Clinical Site Partners, LLC Leesburg dba Flourish Research | Leesburg | Florida | 34748 | United States |
| Suncoast Research Group, LLC Miami - Little Havana dba Flourish Research | Miami | Florida | 33135 | United States |
| Well Pharma Medical Research Corporation | Miami | Florida | 33173 | United States |
| University of South Florida - PARENT | Tampa | Florida | 33613 | United States |
| Clinical Site Partners, LLC Orlando dba Flourish Research | Winter Park | Florida | 32789 | United States |
| Aeroallergy Research Laboratories of Savannah, Inc. | Savannah | Georgia | 31406 | United States |
| Duly Health and Care | Winfield | Illinois | 60190 | United States |
| Accellacare of McFarland Clinic | Ames | Iowa | 50010 | United States |
| The Iowa Clinic, PC | West Des Moines | Iowa | 50266 | United States |
| University of Kansas Medical Center | Kansas City | Kansas | 66160 | United States |
| Bluegrass Allergy Research | Lexington | Kentucky | 40509 | United States |
| Allergy & Asthma Specialists, PSC | Owensboro | Kentucky | 42301 | United States |
| Continental Clinical Solutions, LLC | Towson | Maryland | 21204 | United States |
| Infinity Medical Research Inc | Russells Mills | Massachusetts | 02747 | United States |
| Clinical Research Institute | Minneapolis | Minnesota | 55402 | United States |
| Mayo Clinic - Rochester | Rochester | Minnesota | 55905 | United States |
| The Curators of the University of Missouri on behalf of University of Missouri Health Care | Columbia | Missouri | 65212 | United States |
| Midwest Chest Consultants | Saint Charles | Missouri | 63301 | United States |
| Sundance Clinical Research | St Louis | Missouri | 63141 | United States |
| The Clinical Research Center, LLC | St Louis | Missouri | 63141 | United States |
| Montana Medical Research, Inc. | Missoula | Montana | 59808 | United States |
| AMR Las Vegas | Las Vegas | Nevada | 89119 | United States |
| Hackensack University Medical Center | Hackensack | New Jersey | 07601 | United States |
| Allergy Partners of New Jersey P C | Ocean City | New Jersey | 07712 | United States |
| The Valley Hospital | Paramus | New Jersey | 07652 | United States |
| St Josephs Physicians Med PC Pulmonary Health | Liverpool | New York | 13088 | United States |
| Equity Medical LLC | New York | New York | 10023 | United States |
| Allergy Partners Clinical Research | Asheville | North Carolina | 28803 | United States |
| Clinical Research of Gastonia | Gastonia | North Carolina | 28054 | United States |
| M3 Wake Research, Inc. | Raleigh | North Carolina | 27612 | United States |
| Accellacare | Winston-Salem | North Carolina | 27103 | United States |
| Southeastern Research Center LLC | Winston-Salem | North Carolina | 27103 | United States |
| Remington-Davis, Inc. | Columbus | Ohio | 43215 | United States |
| Lynn Health Science Institute | Oklahoma City | Oklahoma | 73112 | United States |
| Vital Prospects Clinical Research Institute, P.C. | Tulsa | Oklahoma | 74136 | United States |
| Northwest Research Center | Portland | Oregon | 97202 | United States |
| Suburban Research Associates | West Chester | Pennsylvania | 19380 | United States |
| Care Access Research - Warwick 1 | Warwick | Rhode Island | 02886 | United States |
| Lowcountry Lung and Critical Care, P.A. | Charleston | South Carolina | 29406 | United States |
| Accellacare | Mt. Pleasant | South Carolina | 29464 | United States |
| Clinical Research of Rock Hill | Rock Hill | South Carolina | 29732 | United States |
| Internal Medicine and Pediatric Associates of Bristol, PC | Bristol | Tennessee | 37620 | United States |
| Accellacare d/b/a Accellacare of Knoxville | Knoxville | Tennessee | 37938 | United States |
| Pharmaceutical Research & Consulting, Inc. | Dallas | Texas | 75231 | United States |
| Houston Methodist Hospital | Houston | Texas | 77030 | United States |
| South Texas Allergy & Asthma Medical Professionals | San Antonio | Texas | 78229 | United States |
| Alamo ENT Associates | San Antonio | Texas | 78258 | United States |
| TPMG Clinical Research Williamsburg | Williamsburg | Virginia | 23188 | United States |
| Allergy, Asthma & Sinus Center, SC | Greenfield | Wisconsin | 53228 | United States |
| UZ Leuven | Leuven | 3000 | Belgium |
| AZ Sint-Maarten | Mechelen | 2800 | Belgium |
| Pneumocare | Namur | 5380 | Belgium |
| AZ Delta | Roeselare | 8800 | Belgium |
| Dynamic Drug Advancement | Ajax | Ontario | L1S 2J5 | Canada |
| BLC Clinical Research | Burlington | Ontario | L7N 3V2 | Canada |
| McMaster University | Hamilton | Ontario | L8N 3Z5 | Canada |
| Inspiration Research Limited | Toronto | Ontario | M5T 3A9 | Canada |
| Recherche GCP Research | Montreal | Quebec | H1Y 3H5 | Canada |
| DIEX Recherche Quebec Inc. | Québec | Quebec | G1V 4T3 | Canada |
| Clinique Specialisee en Allergie de la Capitale | Québec | Quebec | G1V 4W2 | Canada |
| Clinique de pneumologie et du sommeil de Lanaudière | Saint-Charles-Borromée | Quebec | J6E 2B4 | Canada |
| DIEX Recherche Sherbrooke Inc. | Sherbrooke | Quebec | J1L 0H8 | Canada |
| DIEX Recherche Victoriaville Inc. | Victoriaville | Quebec | G6P 3Z8 | Canada |
| Pneumologisches Studienzentrum Muenchen West | Munich | Bavaria | 81241 | Germany |
| Lungenzentrum Darmstadt | Darmstadt | Hesse | 64283 | Germany |
| Medaimun GmbH | Frankfurt am Main | Hesse | 60596 | Germany |
| Zentrum fuer ambulante pneumologische Forschung Marburg GbR | Marburg | Hesse | 35037 | Germany |
| Pneumologicum Halle | Halle | Saxony-Anhalt | 06108 | Germany |
| Pneumologisches Forschungsinstitut Hohegeest GbR | Geesthacht | Schleswig-Holstein | Germany |
| Velocity Research Germany GmbH | Lübeck | Schleswig-Holstein | 23552 | Germany |
| Pneumologisches Studienzentrum MVZ "Die Lungenärzte" | Berlin | State of Berlin | 10961 | Germany |
| Prywatny Gabinet Internistyczno-Alergologiczny | Bialystok | 15-010 | Poland |
| Prywatna Praktyka Lekarska Gabinet Pediatryczno-Alergologiczny | Bialystok | 15-430 | Poland |
| Centrum Medyczne Pratia Bydgoszcz | Bydgoszcz | 85-796 | Poland |
| Centrum Medyczne Pratia Czestochowa | Częstochowa | 42-217 | Poland |
| Ostrowieckie Centrum Medyczne spółka cywilna Anna Olech-Cudzik, Krzysztof Cudzik | Ostrowiec Świętokrzyski | 27-400 | Poland |
| Centrum Medyczne Lucyna Andrzej Dymek s.c. | Strzelce Opolskie | 47-100 | Poland |
| Gabinet Pulmonologii i Diagnostyki Chorób Alergicznych Dorota Maria Małosek | Szczecin | 70-1111 | Poland |
| Alergo-Med Specjalistyczna Przychodnia Lekarska Sp. Z .O.O. | Tarnów | 33-100 | Poland |
| Ormeau Clinical Trials Ltd | Belfast | Belfast | BT2 8BG | United Kingdom |
| Belfast City Hospital | Belfast | Belfast | BT9 7AB | United Kingdom |
| West Walk Surgery | Bristol | Bristol | BS374AX | United Kingdom |
| Castle Hill Hospital | Cottingham | East Riding of Yorkshire | HU16 5JQ | United Kingdom |
| King's College Hospital | London | Greater London | SE5 9RS | United Kingdom |
| Wythenshawe Hospital | Wythenshawe | Greater Manchester | M23 9LT | United Kingdom |
| Nottingham City Hospital | Nottingham | Nottinghamshire | NG56EG | United Kingdom |
| North Tyneside General Hospital | North Shields | Tyne & Wear | NE29 8NH | United Kingdom |