Study to Assess the Efficacy, Safety, and Tolerability of NOC-110 in Adults With Refractory or Unexplained Chronic Cough

NCT06504446 | Active Not Recruiting Phase 2 FDA Drug

• 1 other identifier: NOC110-C-202
• Study Type: interventional
• Target: 455
• Locations: 6 countries
• Sites: 106

Brief 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.

Conditions

Refractory or Unexplained Chronic Cough

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (6)

• Change in Awake coughs per hour from Baseline

  Baseline to End of Treatment

• Change in the Cough Severity Visual Analog Scale from Baseline

  Baseline to End of Treatment

• Change in the Urge to Cough Visual Analog Scale from Baseline

  Baseline to End of Treatment

• Change in the Leicester Cough Questionnaire from Baseline

  Baseline to End of Treatment

• Patient Global Impressions of Improvement score

  End of Treatment

Other Outcomes (1)

• Change in 24-hour and awake coughs per hour from Baseline with the Hyfe CoughMonitor System

  Baseline to End of Treatment

Study Arms (4)

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.

Drug: NOC-110

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.

Drug: NOC-110

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.

Drug: NOC-110

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.

Other: Placebo

Interventions

NOC-110 DRUG

Inhalation powder

Also known as: taplucainium

NOC-110 1mg; NOC-110 3mg; NOC-110 6mg

Placebo OTHER

Inhalation powder

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Previous exposure to taplucainium (formerly NTX-1175) or known allergy or hypersensitivity to taplucainium, its excipients/metabolites, or related compounds.
• Participants who are currently participating in another drug or device clinical study
• Participants who have participated in an Acute or Chronic Cough investigational study within 60 days before the start of the Screening.
• Current diagnosis of chronic obstructive pulmonary disease, bronchiectasis, unexplained pulmonary fibrosis, hemoptysis, bronchial asthma, or other pulmonary disease.
• Respiratory tract infection within 4 weeks of Screening or during screening period.
• Any female who is pregnant or lactating or wishing to become pregnant.
• Donation of \> 1 Unit (450 milliliter or more) of blood within 60 days prior to the first dosing.
• Alcohol or drug use disorder within the past 2 years.
• Current smoker/vaper or individuals who have given up smoking within the past 6 months of screening, and/or those with \>20 pack-year smoking history.
• Current opiate/opioid use or medical history of opiate/opioid use disorder.
• History of concurrent malignancy or recurrence of malignancy in the last 2 years.
• Body Mass Index of ≥40 kg/m2.
• Positive results for human immunodeficiency virus, hepatitis B, or hepatitis C virus.
• Unable to refrain from the use of medications and treatments that can impact cough during the study.
• Have clinically significant history or evidence of poorly controlled cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, neurological, immunological, or psychiatric disorder(s).

Sponsors & Collaborators

• Nocion Therapeutics: lead
• IQVIA Pty Ltd: collaborator

Study Sites (106)

G & L Research, LLC

Foley, Alabama, 36535, United States

Location

Medical Research of Arizona

Scottsdale, Arizona, 85251, United States

Location

AMR Phoenix

Tempe, Arizona, 85281, United States

Location

Little Rock Allergy & Asthma, P.A. Clinical Research Center

Little Rock, Arkansas, 72205, United States

Location

So Cal Clinical Research

Huntington Beach, California, 92647, United States

Location

Allergy and Asthma Associates of Southern California dba Southern California Research

Laguna Niguel, California, 92677, United States

Location

Paradigm Clinical Research Centers, LLC - Modesto

Modesto, California, 95355, United States

Location

NewportNativeMD,Inc

Newport Beach, California, 92663, United States

Location

Center for Clinical Trials, LLC

Paramount, California, 90723, United States

Location

Paradigm Clinical Research Centers, LLC

Redding, California, 96001, United States

Location

DaVinci Research LLC.

Roseville, California, 95661, United States

Location

Allergy & Asthma Associates of Santa Clara Valley

San Jose, California, 95117, United States

Location

California Allergy & Asthma Medical Group Inc.

San Jose, California, 95117, United States

Location

Allergy, Asthma, and Immunology Medical Group

Ventura, California, 93003, United States

Location

Allergy and Asthma Clinical Research Inc

Walnut Creek, California, 94598, United States

Location

Lynn Institute of Denver

Aurora, Colorado, 80012, United States

Location

Innovative Research of West Florida, Inc.

Clearwater, Florida, 33756, United States

Location

Omega Research Debary, LLC

DeBary, Florida, 32713, United States

Location

Jacksonville Center for Clinical Research

Jacksonville, Florida, 32216, United States

Location

Clinical Site Partners, LLC Leesburg dba Flourish Research

Leesburg, Florida, 34748, United States

Location

Suncoast Research Group, LLC Miami - Little Havana dba Flourish Research

Miami, Florida, 33135, United States

Location

Well Pharma Medical Research Corporation

Miami, Florida, 33173, United States

Location

University of South Florida - PARENT

Tampa, Florida, 33613, United States

Location

Clinical Site Partners, LLC Orlando dba Flourish Research

Winter Park, Florida, 32789, United States

Location

Aeroallergy Research Laboratories of Savannah, Inc.

Savannah, Georgia, 31406, United States

Location

Duly Health and Care

Winfield, Illinois, 60190, United States

Location

Accellacare of McFarland Clinic

Ames, Iowa, 50010, United States

Location

The Iowa Clinic, PC

West Des Moines, Iowa, 50266, United States

Location

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

Bluegrass Allergy Research

Lexington, Kentucky, 40509, United States

Location

Allergy & Asthma Specialists, PSC

Owensboro, Kentucky, 42301, United States

Location

Continental Clinical Solutions, LLC

Towson, Maryland, 21204, United States

Location

Infinity Medical Research Inc

Russells Mills, Massachusetts, 02747, United States

Location

Clinical Research Institute

Minneapolis, Minnesota, 55402, United States

Location

Mayo Clinic - Rochester

Rochester, Minnesota, 55905, United States

Location

The Curators of the University of Missouri on behalf of University of Missouri Health Care

Columbia, Missouri, 65212, United States

Location

Midwest Chest Consultants

Saint Charles, Missouri, 63301, United States

Location

Sundance Clinical Research

St Louis, Missouri, 63141, United States

Location

The Clinical Research Center, LLC

St Louis, Missouri, 63141, United States

Location

Montana Medical Research, Inc.

Missoula, Montana, 59808, United States

Location

AMR Las Vegas

Las Vegas, Nevada, 89119, United States

Location

Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States

Location

Allergy Partners of New Jersey P C

Ocean City, New Jersey, 07712, United States

Location

The Valley Hospital

Paramus, New Jersey, 07652, United States

Location

St Josephs Physicians Med PC Pulmonary Health

Liverpool, New York, 13088, United States

Location

Equity Medical LLC

New York, New York, 10023, United States

Location

Allergy Partners Clinical Research

Asheville, North Carolina, 28803, United States

Location

Clinical Research of Gastonia

Gastonia, North Carolina, 28054, United States

Location

M3 Wake Research, Inc.

Raleigh, North Carolina, 27612, United States

Location

Accellacare

Winston-Salem, North Carolina, 27103, United States

Location

Southeastern Research Center LLC

Winston-Salem, North Carolina, 27103, United States

Location

Remington-Davis, Inc.

Columbus, Ohio, 43215, United States

Location

Lynn Health Science Institute

Oklahoma City, Oklahoma, 73112, United States

Location

Vital Prospects Clinical Research Institute, P.C.

Tulsa, Oklahoma, 74136, United States

Location

Northwest Research Center

Portland, Oregon, 97202, United States

Location

Suburban Research Associates

West Chester, Pennsylvania, 19380, United States

Location

Care Access Research - Warwick 1

Warwick, Rhode Island, 02886, United States

Location

Lowcountry Lung and Critical Care, P.A.

Charleston, South Carolina, 29406, United States

Location

Accellacare

Mt. Pleasant, South Carolina, 29464, United States

Location

Clinical Research of Rock Hill

Rock Hill, South Carolina, 29732, United States

Location

Internal Medicine and Pediatric Associates of Bristol, PC

Bristol, Tennessee, 37620, United States

Location

Accellacare d/b/a Accellacare of Knoxville

Knoxville, Tennessee, 37938, United States

Location

Pharmaceutical Research & Consulting, Inc.

Dallas, Texas, 75231, United States

Location

Houston Methodist Hospital

Houston, Texas, 77030, United States

Location

South Texas Allergy & Asthma Medical Professionals

San Antonio, Texas, 78229, United States

Location

Alamo ENT Associates

San Antonio, Texas, 78258, United States

Location

TPMG Clinical Research Williamsburg

Williamsburg, Virginia, 23188, United States

Location

Allergy, Asthma & Sinus Center, SC

Greenfield, Wisconsin, 53228, United States

Location

UZ Leuven

Leuven, 3000, Belgium

Location

AZ Sint-Maarten

Mechelen, 2800, Belgium

Location

Pneumocare

Namur, 5380, Belgium

Location

AZ Delta

Roeselare, 8800, Belgium

Location

Dynamic Drug Advancement

Ajax, Ontario, L1S 2J5, Canada

Location

BLC Clinical Research

Burlington, Ontario, L7N 3V2, Canada

Location

McMaster University

Hamilton, Ontario, L8N 3Z5, Canada

Location

Inspiration Research Limited

Toronto, Ontario, M5T 3A9, Canada

Location

Recherche GCP Research

Montreal, Quebec, H1Y 3H5, Canada

Location

DIEX Recherche Quebec Inc.

Québec, Quebec, G1V 4T3, Canada

Location

Clinique Specialisee en Allergie de la Capitale

Québec, Quebec, G1V 4W2, Canada

Location

Clinique de pneumologie et du sommeil de Lanaudière

Saint-Charles-Borromée, Quebec, J6E 2B4, Canada

Location

DIEX Recherche Sherbrooke Inc.

Sherbrooke, Quebec, J1L 0H8, Canada

Location

DIEX Recherche Victoriaville Inc.

Victoriaville, Quebec, G6P 3Z8, Canada

Location

Pneumologisches Studienzentrum Muenchen West

Munich, Bavaria, 81241, Germany

Location

Lungenzentrum Darmstadt

Darmstadt, Hesse, 64283, Germany

Location

Medaimun GmbH

Frankfurt am Main, Hesse, 60596, Germany

Location

Zentrum fuer ambulante pneumologische Forschung Marburg GbR

Marburg, Hesse, 35037, Germany

Location

Pneumologicum Halle

Halle, Saxony-Anhalt, 06108, Germany

Location

Pneumologisches Forschungsinstitut Hohegeest GbR

Geesthacht, Schleswig-Holstein, Germany

Location

Velocity Research Germany GmbH

Lübeck, Schleswig-Holstein, 23552, Germany

Location

Pneumologisches Studienzentrum MVZ "Die Lungenärzte"

Berlin, State of Berlin, 10961, Germany

Location

Prywatny Gabinet Internistyczno-Alergologiczny

Bialystok, 15-010, Poland

Location

Prywatna Praktyka Lekarska Gabinet Pediatryczno-Alergologiczny

Bialystok, 15-430, Poland

Location

Centrum Medyczne Pratia Bydgoszcz

Bydgoszcz, 85-796, Poland

Location

Centrum Medyczne Pratia Czestochowa

Częstochowa, 42-217, Poland

Location

Ostrowieckie Centrum Medyczne spółka cywilna Anna Olech-Cudzik, Krzysztof Cudzik

Ostrowiec Świętokrzyski, 27-400, Poland

Location

Centrum Medyczne Lucyna Andrzej Dymek s.c.

Strzelce Opolskie, 47-100, Poland

Location

Gabinet Pulmonologii i Diagnostyki Chorób Alergicznych Dorota Maria Małosek

Szczecin, 70-1111, Poland

Location

Alergo-Med Specjalistyczna Przychodnia Lekarska Sp. Z .O.O.

Tarnów, 33-100, Poland

Location

Ormeau Clinical Trials Ltd

Belfast, Belfast, BT2 8BG, United Kingdom

Location

Belfast City Hospital

Belfast, Belfast, BT9 7AB, United Kingdom

Location

West Walk Surgery

Bristol, Bristol, BS374AX, United Kingdom

Location

Castle Hill Hospital

Cottingham, East Riding of Yorkshire, HU16 5JQ, United Kingdom

Location

King's College Hospital

London, Greater London, SE5 9RS, United Kingdom

Location

Wythenshawe Hospital

Wythenshawe, Greater Manchester, M23 9LT, United Kingdom

Location

Nottingham City Hospital

Nottingham, Nottinghamshire, NG56EG, United Kingdom

Location

North Tyneside General Hospital

North Shields, Tyne & Wear, NE29 8NH, United Kingdom

Location

Study Officials

• Matthew Frankel, MD

  Chief Medical Officer Nocion Therapeutics, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2024
• First Posted: July 16, 2024
• Study Start: September 24, 2024
• Primary Completion: June 15, 2026
• Study Completion: June 29, 2026
• Last Updated: June 11, 2026

Record last verified: 2026-06

Locations

DE (8); GB (8); US (68); CA (10); BE (4); PL (8)