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: Recruiting
Location: See all (107) 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
RECRUITING
Foley
Arkansas
Little Rock Allergy & Asthma, P.A. Clinical Research Center
RECRUITING
Little Rock
Arizona
Medical Research of Arizona
RECRUITING
Scottsdale
AMR Phoenix
RECRUITING
Tempe
California
So Cal Clinical Research
RECRUITING
Huntington Beach
Allergy and Asthma Associates of Southern California dba Southern California Research
RECRUITING
Laguna Niguel
Paradigm Clinical Research Centers, LLC - Modesto
RECRUITING
Modesto
NewportNativeMD,Inc
RECRUITING
Newport Beach
Center for Clinical Trials, LLC
RECRUITING
Paramount
Paradigm Clinical Research Centers, LLC
RECRUITING
Redding
DaVinci Research LLC.
RECRUITING
Roseville
Allergy & Asthma Associates of Santa Clara Valley
RECRUITING
San Jose
California Allergy & Asthma Medical Group Inc.
RECRUITING
San Jose
Allergy, Asthma, and Immunology Medical Group
RECRUITING
Ventura
Allergy and Asthma Clinical Research Inc
RECRUITING
Walnut Creek
Colorado
Lynn Institute of Denver
RECRUITING
Aurora
Florida
Innovative Research of West Florida, Inc.
RECRUITING
Clearwater
Omega Research Debary, LLC
RECRUITING
Debary
Jacksonville Center for Clinical Research
RECRUITING
Jacksonville
Clinical Site Partners, LLC Leesburg dba Flourish Research
RECRUITING
Leesburg
Suncoast Research Group, LLC Miami - Little Havana dba Flourish Research
RECRUITING
Miami
Well Pharma Medical Research Corporation
RECRUITING
Miami
University of South Florida - PARENT
RECRUITING
Tampa
Clinical Site Partners, LLC Orlando dba Flourish Research
RECRUITING
Winter Park
Clinical Site Partners, LLC Orlando dba Flourish Research
RECRUITING
Winter Park
Georgia
Aeroallergy Research Laboratories of Savannah, Inc.
RECRUITING
Savannah
Iowa
Accellacare of McFarland Clinic
RECRUITING
Ames
The Iowa Clinic, PC
RECRUITING
West Des Moines
Illinois
Duly Health and Care
RECRUITING
Winfield
Kansas
University of Kansas Medical Center
RECRUITING
Kansas City
Kentucky
Bluegrass Allergy Research
RECRUITING
Lexington
Allergy & Asthma Specialists, PSC
RECRUITING
Owensboro
Massachusetts
Infinity Medical Research Inc
RECRUITING
Russells Mills
Maryland
Continental Clinical Solutions, LLC
RECRUITING
Towson
Minnesota
Clinical Research Institute
RECRUITING
Minneapolis
Mayo Clinic - Rochester
RECRUITING
Rochester
Missouri
The Curators of the University of Missouri on behalf of University of Missouri Health Care
RECRUITING
Columbia
Midwest Chest Consultants
RECRUITING
Saint Charles
Sundance Clinical Research
RECRUITING
St Louis
The Clinical Research Center, LLC
RECRUITING
St Louis
Montana
Montana Medical Research, Inc.
RECRUITING
Missoula
North Carolina
Allergy Partners Clinical Research
RECRUITING
Asheville
Clinical Research of Gastonia
RECRUITING
Gastonia
M3 Wake Research, Inc.
RECRUITING
Raleigh
Accellacare
RECRUITING
Winston-salem
Southeastern Research Center LLC
RECRUITING
Winston-salem
New Jersey
Hackensack University Medical Center
RECRUITING
Hackensack
Allergy Partners of New Jersey P C
RECRUITING
Ocean City
The Valley Hospital
RECRUITING
Paramus
Nevada
AMR Las Vegas
RECRUITING
Las Vegas
New York
St Josephs Physicians Med PC Pulmonary Health
RECRUITING
Liverpool
Equity Medical LLC
RECRUITING
New York
Ohio
Remington-Davis, Inc.
RECRUITING
Columbus
Oklahoma
Lynn Health Science Institute
RECRUITING
Oklahoma City
Vital Prospects Clinical Research Institute, P.C.
RECRUITING
Tulsa
Oregon
Northwest Research Center
RECRUITING
Portland
Pennsylvania
Suburban Research Associates
RECRUITING
West Chester
Rhode Island
Care Access Research - Warwick 1
RECRUITING
Warwick
South Carolina
Lowcountry Lung and Critical Care, P.A.
RECRUITING
Charleston
Accellacare
RECRUITING
Mt. Pleasant
Clinical Research of Rock Hill
RECRUITING
Rock Hill
Tennessee
Internal Medicine and Pediatric Associates of Bristol, PC
RECRUITING
Bristol
Accellacare d/b/a Accellacare of Knoxville
RECRUITING
Knoxville
Texas
Pharmaceutical Research & Consulting, Inc.
RECRUITING
Dallas
Houston Methodist Hospital
RECRUITING
Houston
Alamo ENT Associates
RECRUITING
San Antonio
South Texas Allergy & Asthma Medical Professionals
RECRUITING
San Antonio
Virginia
TPMG Clinical Research Williamsburg
RECRUITING
Williamsburg
Wisconsin
Allergy, Asthma & Sinus Center, SC
RECRUITING
Greenfield
Other Locations
Belgium
UZ Leuven
RECRUITING
Leuven
AZ Sint-Maarten
RECRUITING
Mechelen
Pneumocare
RECRUITING
Namur
AZ Delta
RECRUITING
Roeselare
Canada
Dynamic Drug Advancement
RECRUITING
Ajax
BLC Clinical Research
RECRUITING
Burlington
McMaster University
RECRUITING
Hamilton
Recherche GCP Research
RECRUITING
Montreal
Clinique Specialisee en Allergie de la Capitale
RECRUITING
Québec
DIEX Recherche Quebec Inc.
RECRUITING
Québec
Clinique de pneumologie et du sommeil de Lanaudière
ACTIVE_NOT_RECRUITING
Saint-charles-borromée
DIEX Recherche Sherbrooke Inc.
RECRUITING
Sherbrooke
Inspiration Research Limited
RECRUITING
Toronto
DIEX Recherche Victoriaville Inc.
RECRUITING
Victoriaville
Germany
Pneumologisches Studienzentrum MVZ Die Lungenärzte
RECRUITING
Berlin
Lungenzentrum Darmstadt
RECRUITING
Darmstadt
Medaimun GmbH
RECRUITING
Frankfurt Am Main
Pneumologisches Forschungsinstitut Hohegeest GbR
RECRUITING
Geesthacht
Pneumologicum Halle
RECRUITING
Halle
Velocity Research Germany GmbH
RECRUITING
Lübeck
Zentrum fuer ambulante pneumologische Forschung Marburg GbR
RECRUITING
Marburg
Pneumologisches Studienzentrum Muenchen West
RECRUITING
Munich
Poland
Prywatna Praktyka Lekarska Gabinet Pediatryczno-Alergologiczny
RECRUITING
Bialystok
Prywatny Gabinet Internistyczno-Alergologiczny
RECRUITING
Bialystok
Centrum Medyczne Pratia Bydgoszcz
RECRUITING
Bydgoszcz
Centrum Medyczne Pratia Czestochowa
RECRUITING
Częstochowa
Ostrowieckie Centrum Medyczne spółka cywilna Anna Olech-Cudzik, Krzysztof Cudzik
RECRUITING
Ostrowiec Świętokrzyski
Centrum Medyczne Lucyna Andrzej Dymek s.c.
RECRUITING
Strzelce Opolskie
Gabinet Pulmonologii i Diagnostyki Chorób Alergicznych Dorota Maria Małosek
RECRUITING
Szczecin
Alergo-Med Specjalistyczna Przychodnia Lekarska Sp. Z .O.O.
RECRUITING
Tarnów
United Kingdom
Belfast City Hospital
RECRUITING
Belfast
Ormeau Clinical Trials Ltd
RECRUITING
Belfast
West Walk Surgery
RECRUITING
Bristol
Castle Hill Hospital
RECRUITING
Cottingham
King's College Hospital
RECRUITING
London
North Tyneside General Hospital
RECRUITING
North Shields
Nottingham City Hospital
RECRUITING
Nottingham
Wythenshawe Hospital
RECRUITING
Wythenshawe
Contact Information
Primary
Nocion Clinical Trials
clinicaltrials@nociontx.com
781-761-2050
Time Frame
Start Date: 2024-09-24
Estimated Completion Date: 2026-04-10
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