A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy, Safety, and Tolerability of Taplucainium Inhalation Powder (NOC-110) in Adults With Refractory or Unexplained Chronic Cough
Status: Active_not_recruiting
Location: See all (106) locations...
Intervention Type: Other, Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:
• Refractory or unexplained chronic cough for ≥ 12 months.
• Women of childbearing potential agree to follow the protocol specified contraceptive - guidance during the study.
• Males who are not vasectomized must agree to use the contraceptive methods defined in the protocol.
• Able to provide Informed Consent.
Locations
United States
Alabama
G & L Research, LLC
Foley
Arkansas
Little Rock Allergy & Asthma, P.A. Clinical Research Center
Little Rock
Arizona
Medical Research of Arizona
Scottsdale
AMR Phoenix
Tempe
California
So Cal Clinical Research
Huntington Beach
Allergy and Asthma Associates of Southern California dba Southern California Research
Laguna Niguel
Paradigm Clinical Research Centers, LLC - Modesto
Modesto
NewportNativeMD,Inc
Newport Beach
Center for Clinical Trials, LLC
Paramount
Paradigm Clinical Research Centers, LLC
Redding
DaVinci Research LLC.
Roseville
Allergy & Asthma Associates of Santa Clara Valley
San Jose
California Allergy & Asthma Medical Group Inc.
San Jose
Allergy, Asthma, and Immunology Medical Group
Ventura
Allergy and Asthma Clinical Research Inc
Walnut Creek
Colorado
Lynn Institute of Denver
Aurora
Florida
Innovative Research of West Florida, Inc.
Clearwater
Omega Research Debary, LLC
Debary
Jacksonville Center for Clinical Research
Jacksonville
Clinical Site Partners, LLC Leesburg dba Flourish Research
Leesburg
Suncoast Research Group, LLC Miami - Little Havana dba Flourish Research
Miami
Well Pharma Medical Research Corporation
Miami
University of South Florida - PARENT
Tampa
Clinical Site Partners, LLC Orlando dba Flourish Research
Winter Park
Georgia
Aeroallergy Research Laboratories of Savannah, Inc.
Savannah
Iowa
Accellacare of McFarland Clinic
Ames
The Iowa Clinic, PC
West Des Moines
Illinois
Duly Health and Care
Winfield
Kansas
University of Kansas Medical Center
Kansas City
Kentucky
Bluegrass Allergy Research
Lexington
Allergy & Asthma Specialists, PSC
Owensboro
Massachusetts
Infinity Medical Research Inc
Russells Mills
Maryland
Continental Clinical Solutions, LLC
Towson
Minnesota
Clinical Research Institute
Minneapolis
Mayo Clinic - Rochester
Rochester
Missouri
The Curators of the University of Missouri on behalf of University of Missouri Health Care
Columbia
Midwest Chest Consultants
Saint Charles
Sundance Clinical Research
St Louis
The Clinical Research Center, LLC
St Louis
Montana
Montana Medical Research, Inc.
Missoula
North Carolina
Allergy Partners Clinical Research
Asheville
Clinical Research of Gastonia
Gastonia
M3 Wake Research, Inc.
Raleigh
Accellacare
Winston-salem
Southeastern Research Center LLC
Winston-salem
New Jersey
Hackensack University Medical Center
Hackensack
Allergy Partners of New Jersey P C
Ocean City
The Valley Hospital
Paramus
Nevada
AMR Las Vegas
Las Vegas
New York
St Josephs Physicians Med PC Pulmonary Health
Liverpool
Equity Medical LLC
New York
Ohio
Remington-Davis, Inc.
Columbus
Oklahoma
Lynn Health Science Institute
Oklahoma City
Vital Prospects Clinical Research Institute, P.C.
Tulsa
Oregon
Northwest Research Center
Portland
Pennsylvania
Suburban Research Associates
West Chester
Rhode Island
Care Access Research - Warwick 1
Warwick
South Carolina
Lowcountry Lung and Critical Care, P.A.
Charleston
Accellacare
Mt. Pleasant
Clinical Research of Rock Hill
Rock Hill
Tennessee
Internal Medicine and Pediatric Associates of Bristol, PC
Bristol
Accellacare d/b/a Accellacare of Knoxville
Knoxville
Texas
Pharmaceutical Research & Consulting, Inc.
Dallas
Houston Methodist Hospital
Houston
Alamo ENT Associates
San Antonio
South Texas Allergy & Asthma Medical Professionals
San Antonio
Virginia
TPMG Clinical Research Williamsburg
Williamsburg
Wisconsin
Allergy, Asthma & Sinus Center, SC
Greenfield
Other Locations
Belgium
UZ Leuven
Leuven
AZ Sint-Maarten
Mechelen
Pneumocare
Namur
AZ Delta
Roeselare
Canada
Dynamic Drug Advancement
Ajax
BLC Clinical Research
Burlington
McMaster University
Hamilton
Recherche GCP Research
Montreal
Clinique Specialisee en Allergie de la Capitale
Québec
DIEX Recherche Quebec Inc.
Québec
Clinique de pneumologie et du sommeil de Lanaudière
Saint-charles-borromée
DIEX Recherche Sherbrooke Inc.
Sherbrooke
Inspiration Research Limited
Toronto
DIEX Recherche Victoriaville Inc.
Victoriaville
Germany
Pneumologisches Studienzentrum MVZ Die Lungenärzte
Berlin
Lungenzentrum Darmstadt
Darmstadt
Medaimun GmbH
Frankfurt Am Main
Pneumologisches Forschungsinstitut Hohegeest GbR
Geesthacht
Pneumologicum Halle
Halle
Velocity Research Germany GmbH
Lübeck
Zentrum fuer ambulante pneumologische Forschung Marburg GbR
Marburg
Pneumologisches Studienzentrum Muenchen West
Munich
Poland
Prywatna Praktyka Lekarska Gabinet Pediatryczno-Alergologiczny
Bialystok
Prywatny Gabinet Internistyczno-Alergologiczny
Bialystok
Centrum Medyczne Pratia Bydgoszcz
Bydgoszcz
Centrum Medyczne Pratia Czestochowa
Częstochowa
Ostrowieckie Centrum Medyczne spółka cywilna Anna Olech-Cudzik, Krzysztof Cudzik
Ostrowiec Świętokrzyski
Centrum Medyczne Lucyna Andrzej Dymek s.c.
Strzelce Opolskie
Gabinet Pulmonologii i Diagnostyki Chorób Alergicznych Dorota Maria Małosek
Szczecin
Alergo-Med Specjalistyczna Przychodnia Lekarska Sp. Z .O.O.
Tarnów
United Kingdom
Belfast City Hospital
Belfast
Ormeau Clinical Trials Ltd
Belfast
West Walk Surgery
Bristol
Castle Hill Hospital
Cottingham
King's College Hospital
London
North Tyneside General Hospital
North Shields
Nottingham City Hospital
Nottingham
Wythenshawe Hospital
Wythenshawe
Time Frame
Start Date: 2024-09-24
Completion Date: 2026-06-29
Participants
Target number of participants: 455
Treatments
Experimental: NOC-110 1mg
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.
Experimental: NOC-110 3mg
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.
Experimental: NOC-110 6mg
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_comparator: Placebo
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.
Related Therapeutic Areas
Sponsors
Collaborators: IQVIA Pty Ltd
Leads: Nocion Therapeutics