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

Last updated: February 21, 2025
Sponsor: Nocion Therapeutics
Overall Status: Active - Recruiting

Phase

2

Condition

Chronic Cough

Treatment

NOC-110

Placebo

Clinical Study ID

NCT06504446
NOC110-C-202
  • Ages 18-80
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  • 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 definedin the protocol.

  • Able to provide Informed Consent.

Exclusion

Exclusion Criteria:

  • Previous exposure to taplucainium (formerly NTX-1175) or known allergy orhypersensitivity to taplucainium, its excipients/metabolites, or related compounds.

  • Participants who are currently participating in another drug or device clinicalstudy

  • Participants who have participated in an Acute or Chronic Cough investigationalstudy 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 pulmonarydisease.

  • 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 90 days prior to thefirst dosing.

  • Alcohol or drug use disorder within the past 2 years.

  • Current smoker/vaper or individuals who have given up smoking within the past 6months, and/or those with >20 pack-year smoking history.

  • Current opiate/opioid use or medical history of opiate/opioid use disorder. Historyof 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 Cvirus.

  • Unable to refrain from the use of medications and treatments that can impact coughduring the study.

  • Have clinically significant history or evidence of poorly controlled cardiovascular,respiratory, hepatic, renal, gastrointestinal, endocrine, neurological,immunological, or psychiatric disorder(s).

Study Design

Total Participants: 325
Treatment Group(s): 2
Primary Treatment: NOC-110
Phase: 2
Study Start date:
September 24, 2024
Estimated Completion Date:
November 10, 2025

Study Description

Approximately 325 participants will take part in the study. It is anticipated that up to 600 participants will be screened. Participation will be approximately 13 weeks.

Connect with a study center

  • UZ Leuven

    Leuven, 3000
    Belgium

    Active - Recruiting

  • AZ Sint-Maarten

    Mechelen, 2800
    Belgium

    Active - Recruiting

  • Pneumocare

    Namur, 5380
    Belgium

    Active - Recruiting

  • AZ Delta

    Roeselare, 8800
    Belgium

    Active - Recruiting

  • Dynamic Drug Advancement

    Ajex, Ontario L1S 2J5
    Canada

    Active - Recruiting

  • McMaster University

    Hamilton, Ontario L8N 3Z5
    Canada

    Active - Recruiting

  • Inspiration Research Limited

    Toronto, Ontario M5T 3A9
    Canada

    Active - Recruiting

  • Recherche GCP Research

    Montréal, Quebec H1Y 3H5
    Canada

    Active - Recruiting

  • Clinique Specialisee en Allergie de la Capitale

    Québec, Quebec G1V 4W2
    Canada

    Active - Recruiting

  • Clinique de pneumologie et du sommeil de Lanaudière

    Saint-Charles-Borromee, Quebec J6E 2B4
    Canada

    Active - Recruiting

  • DIEX Recherche Sherbrooke Inc.

    Sherbrooke, Quebec J1L 0H8
    Canada

    Active - Recruiting

  • DIEX Recherche Victoriaville Inc.

    Victoriaville, Quebec G6P 3Z8
    Canada

    Active - Recruiting

  • DIEX Recherche Quebec Inc.

    Quebec, G1V 4T3
    Canada

    Active - Recruiting

  • Pneumologisches Studienzentrum Muenchen West

    Muenchen, Bayern 81241
    Germany

    Active - Recruiting

  • Lungenzentrum Darmstadt

    Darmstadt, Hessen 64283
    Germany

    Active - Recruiting

  • Medaimun GmbH

    Frankfurt, Hessen 60596
    Germany

    Active - Recruiting

  • Zentrum fuer ambulante pneumologische Forschung Marburg GbR

    Marburg, Hessen 35037
    Germany

    Active - Recruiting

  • Pneumologicum Halle

    Halle, Sachsen Anhalt 06108
    Germany

    Active - Recruiting

  • Pneumologisches Forschungsinstitut Hohegeest GbR

    Geesthacht, Schleswig Holstein
    Germany

    Active - Recruiting

  • Pneumologisches Studienzentrum MVZ "Die Lungenärzte"

    Berlin, 10961
    Germany

    Active - Recruiting

  • Prywatny Gabinet Internistyczno-Alergologiczny

    Bialystok, 15-010
    Poland

    Active - Recruiting

  • Centrum Medyczne Pratia Bydgoszcz

    Bydgoszcz, 85-796
    Poland

    Active - Recruiting

  • Centrum Medyczne Pratia Czestochowa

    Częstochowa, 42-217
    Poland

    Active - Recruiting

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

    Ostrowiec Swietokrzyski, 27-400
    Poland

    Active - Recruiting

  • Centrum Medyczne Lucyna Andrzej Dymek s.c.

    Strzelce Opolskie, 47-100
    Poland

    Active - Recruiting

  • Gabinet Pulmonologii i Diagnostyki Chorób Alergicznych Dorota Maria Małosek

    Szczecin, 70-1111
    Poland

    Active - Recruiting

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

    Tarnow, 33-100
    Poland

    Active - Recruiting

  • Ormeau Clinical Trials Ltd

    Belfast, BT2 8BG
    United Kingdom

    Active - Recruiting

  • West Walk Surgery

    Bristol, BS374AX
    United Kingdom

    Active - Recruiting

  • G & L Research, LLC

    Foley, Alabama 36535
    United States

    Active - Recruiting

  • AMR Phoenix

    Tempe, Arizona 85281
    United States

    Active - Recruiting

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

    Little Rock, Arkansas 72205
    United States

    Active - Recruiting

  • Allergy and Asthma Associates of Southern California dba Southern California Research

    Laguna Niguel, California 92677
    United States

    Active - Recruiting

  • NewportNativeMD,Inc

    Newport Beach, California 92663
    United States

    Active - Recruiting

  • Center for Clinical Trials, LLC

    Paramount, California 90723
    United States

    Active - Recruiting

  • Paradigm Clinical Research Centers, LLC

    Redding, California 96001
    United States

    Active - Recruiting

  • Allergy & Asthma Associates of Santa Clara Valley

    San Jose, California 95117
    United States

    Active - Recruiting

  • California Allergy & Asthma Medical Group Inc.

    San Jose, California 95117
    United States

    Active - Recruiting

  • Allergy and Asthma Clinical Research Inc

    Walnut Creek, California 94598
    United States

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  • Lynn Institute of Denver

    Aurora, Colorado 80012
    United States

    Active - Recruiting

  • Innovative Research of West Florida, Inc.

    Clearwater, Florida 33756
    United States

    Active - Recruiting

  • Omega Research Debary, LLC

    Debary, Florida 32713
    United States

    Active - Recruiting

  • Jacksonville Center for Clinical Research

    Jacksonville, Florida 32216
    United States

    Active - Recruiting

  • Clinical Site Partners, LLC Leesburg dba Flourish Research

    Leesburg, Florida 34748
    United States

    Active - Recruiting

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

    Miami, Florida 33135
    United States

    Active - Recruiting

  • Well Pharma Medical Research Corporation

    Miami, Florida 33173
    United States

    Active - Recruiting

  • Clinical Site Partners, LLC Orlando dba Flourish Research

    Winter Park, Florida 32789
    United States

    Active - Recruiting

  • Duly Health and Care

    Winfield, Illinois 60190
    United States

    Active - Recruiting

  • Accellacare of McFarland Clinic

    Ames, Iowa 50010
    United States

    Active - Recruiting

  • The Iowa Clinic, PC

    West Des Moines, Iowa 50266
    United States

    Active - Recruiting

  • Bluegrass Allergy Research

    Lexington, Kentucky 40509
    United States

    Active - Recruiting

  • Allergy & Asthma Specialists, PSC

    Owensboro, Kentucky 42301
    United States

    Active - Recruiting

  • Continental Clinical Solutions, LLC

    Towson, Maryland 21204
    United States

    Active - Recruiting

  • Infinity Medical Research Inc

    Dartmouth, Massachusetts 02747
    United States

    Active - Recruiting

  • Infinity Medical Research Inc

    South Dartmouth, Massachusetts 02747
    United States

    Site Not Available

  • Clinical Research Institute

    Minneapolis, Minnesota 55402
    United States

    Active - Recruiting

  • Midwest Chest Consultants

    Saint Charles, Missouri 63301
    United States

    Site Not Available

  • Sundance Clinical Research

    Saint Louis, Missouri 63141
    United States

    Site Not Available

  • The Clinical Research Center, LLC

    Saint Louis, Missouri 63141
    United States

    Active - Recruiting

  • Midwest Chest Consultants

    St. Charles, Missouri 63301
    United States

    Active - Recruiting

  • Sundance Clinical Research

    St. Louis, Missouri 63141
    United States

    Active - Recruiting

  • The Clinical Research Center, LLC

    St. Louis, Missouri 63141
    United States

    Active - Recruiting

  • Montana Medical Research, Inc.

    Missoula, Montana 59808
    United States

    Active - Recruiting

  • AMR Las Vegas

    Las Vegas, Nevada 89119
    United States

    Active - Recruiting

  • Allergy Partners of New Jersey P C

    Ocean, New Jersey 07712
    United States

    Active - Recruiting

  • Allergy Partners of New Jersey P C

    Ocean City, New Jersey 07712
    United States

    Site Not Available

  • Allergy Partners Clinical Research

    Asheville, North Carolina 28803
    United States

    Active - Recruiting

  • Clinical Research of Gastonia

    Gastonia, North Carolina 28054
    United States

    Active - Recruiting

  • M3 Wake Research, Inc.

    Raleigh, North Carolina 27612
    United States

    Active - Recruiting

  • Southeastern Research Center LLC

    Winston Salem, North Carolina 27103
    United States

    Active - Recruiting

  • Accellacare

    Winston-Salem, North Carolina 27103
    United States

    Active - Recruiting

  • Southeastern Research Center LLC

    Winston-Salem, North Carolina 27103
    United States

    Active - Recruiting

  • Remington-Davis, Inc.

    Columbus, Ohio 43215
    United States

    Active - Recruiting

  • Lynn Health Science Institute

    Oklahoma City, Oklahoma 73112
    United States

    Active - Recruiting

  • Vital Prospects Clinical Research Institute, P.C.

    Tulsa, Oklahoma 74136
    United States

    Active - Recruiting

  • Northwest Research Center

    Portland, Oregon 97202
    United States

    Active - Recruiting

  • Care Access Research - Warwick 1

    Warwick, Rhode Island 02886
    United States

    Active - Recruiting

  • Lowcountry Lung and Critical Care, P.A.

    Charleston, South Carolina 29406
    United States

    Active - Recruiting

  • Accellacare

    Mount Pleasant, South Carolina 29464
    United States

    Active - Recruiting

  • National Allergy and Asthma Research, LLC

    North Charleston, South Carolina 29420
    United States

    Active - Recruiting

  • Clinical Research of Rock Hill

    Rock Hill, South Carolina 29732
    United States

    Active - Recruiting

  • Internal Medicine and Pediatric Associates of Bristol, PC

    Bristol, Tennessee 37620
    United States

    Active - Recruiting

  • Accellacare d/b/a Accellacare of Knoxville

    Knoxville, Tennessee 37938
    United States

    Active - Recruiting

  • Pharmaceutical Research & Consulting, Inc.

    Dallas, Texas 75231
    United States

    Active - Recruiting

  • Alamo ENT Associates

    San Antonio, Texas 78258
    United States

    Active - Recruiting

  • South Texas Allergy & Asthma Medical Professionals

    San Antonio, Texas 78229
    United States

    Active - Recruiting

  • TPMG Clinical Research Williamsburg

    Williamsburg, Virginia 23188
    United States

    Active - Recruiting

  • Allergy, Asthma & Sinus Center, SC

    Greenfield, Wisconsin 53228
    United States

    Active - Recruiting

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