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

NCT ID: NCT06504446

Last Updated: 2025-11-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

455 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-24

Study Completion Date

2026-04-10

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Refractory or Unexplained Chronic Cough

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

NOC-110

Intervention Type DRUG

Inhalation powder

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.

Group Type EXPERIMENTAL

NOC-110

Intervention Type DRUG

Inhalation powder

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.

Group Type EXPERIMENTAL

NOC-110

Intervention Type DRUG

Inhalation powder

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.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Inhalation powder

Interventions

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NOC-110

Inhalation powder

Intervention Type DRUG

Placebo

Inhalation powder

Intervention Type OTHER

Other Intervention Names

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taplucainium

Eligibility Criteria

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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 defined in the protocol.
* Able to provide Informed Consent.

Exclusion Criteria

* 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).
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nocion Therapeutics

INDUSTRY

Sponsor Role lead

Iqvia Pty Ltd

INDUSTRY

Sponsor Role collaborator

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Matthew Frankel, MD

Role: STUDY_DIRECTOR

Chief Medical Officer Nocion Therapeutics, Inc.

Locations

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G & L Research, LLC

Foley, Alabama, United States

Site Status RECRUITING

Medical Research of Arizona

Scottsdale, Arizona, United States

Site Status RECRUITING

AMR Phoenix

Tempe, Arizona, United States

Site Status RECRUITING

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

Little Rock, Arkansas, United States

Site Status RECRUITING

So Cal Clinical Research

Huntington Beach, California, United States

Site Status RECRUITING

Allergy and Asthma Associates of Southern California dba Southern California Research

Laguna Niguel, California, United States

Site Status RECRUITING

Paradigm Clinical Research Centers, LLC - Modesto

Modesto, California, United States

Site Status RECRUITING

NewportNativeMD,Inc

Newport Beach, California, United States

Site Status RECRUITING

Center for Clinical Trials, LLC

Paramount, California, United States

Site Status RECRUITING

Paradigm Clinical Research Centers, LLC

Redding, California, United States

Site Status RECRUITING

DaVinci Research LLC.

Roseville, California, United States

Site Status RECRUITING

Allergy & Asthma Associates of Santa Clara Valley

San Jose, California, United States

Site Status RECRUITING

California Allergy & Asthma Medical Group Inc.

San Jose, California, United States

Site Status RECRUITING

Allergy, Asthma, and Immunology Medical Group

Ventura, California, United States

Site Status RECRUITING

Allergy and Asthma Clinical Research Inc

Walnut Creek, California, United States

Site Status RECRUITING

Lynn Institute of Denver

Aurora, Colorado, United States

Site Status RECRUITING

Innovative Research of West Florida, Inc.

Clearwater, Florida, United States

Site Status RECRUITING

Omega Research Debary, LLC

DeBary, Florida, United States

Site Status RECRUITING

Jacksonville Center for Clinical Research

Jacksonville, Florida, United States

Site Status RECRUITING

Clinical Site Partners, LLC Leesburg dba Flourish Research

Leesburg, Florida, United States

Site Status RECRUITING

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

Miami, Florida, United States

Site Status RECRUITING

Well Pharma Medical Research Corporation

Miami, Florida, United States

Site Status RECRUITING

University of South Florida - PARENT

Tampa, Florida, United States

Site Status RECRUITING

Clinical Site Partners, LLC Orlando dba Flourish Research

Winter Park, Florida, United States

Site Status RECRUITING

Clinical Site Partners, LLC Orlando dba Flourish Research

Winter Park, Florida, United States

Site Status RECRUITING

Aeroallergy Research Laboratories of Savannah, Inc.

Savannah, Georgia, United States

Site Status RECRUITING

Duly Health and Care

Winfield, Illinois, United States

Site Status RECRUITING

Accellacare of McFarland Clinic

Ames, Iowa, United States

Site Status RECRUITING

The Iowa Clinic, PC

West Des Moines, Iowa, United States

Site Status RECRUITING

University of Kansas Medical Center

Kansas City, Kansas, United States

Site Status RECRUITING

Bluegrass Allergy Research

Lexington, Kentucky, United States

Site Status RECRUITING

Allergy & Asthma Specialists, PSC

Owensboro, Kentucky, United States

Site Status RECRUITING

Continental Clinical Solutions, LLC

Towson, Maryland, United States

Site Status RECRUITING

Infinity Medical Research Inc

Russells Mills, Massachusetts, United States

Site Status RECRUITING

Clinical Research Institute

Minneapolis, Minnesota, United States

Site Status RECRUITING

Mayo Clinic - Rochester

Rochester, Minnesota, United States

Site Status RECRUITING

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

Columbia, Missouri, United States

Site Status RECRUITING

Midwest Chest Consultants

Saint Charles, Missouri, United States

Site Status RECRUITING

Sundance Clinical Research

St Louis, Missouri, United States

Site Status RECRUITING

The Clinical Research Center, LLC

St Louis, Missouri, United States

Site Status RECRUITING

Montana Medical Research, Inc.

Missoula, Montana, United States

Site Status RECRUITING

AMR Las Vegas

Las Vegas, Nevada, United States

Site Status RECRUITING

Hackensack University Medical Center

Hackensack, New Jersey, United States

Site Status RECRUITING

Allergy Partners of New Jersey P C

Ocean City, New Jersey, United States

Site Status RECRUITING

The Valley Hospital

Paramus, New Jersey, United States

Site Status RECRUITING

St Josephs Physicians Med PC Pulmonary Health

Liverpool, New York, United States

Site Status RECRUITING

Equity Medical LLC

New York, New York, United States

Site Status RECRUITING

Allergy Partners Clinical Research

Asheville, North Carolina, United States

Site Status RECRUITING

Clinical Research of Gastonia

Gastonia, North Carolina, United States

Site Status RECRUITING

M3 Wake Research, Inc.

Raleigh, North Carolina, United States

Site Status RECRUITING

Accellacare

Winston-Salem, North Carolina, United States

Site Status RECRUITING

Southeastern Research Center LLC

Winston-Salem, North Carolina, United States

Site Status RECRUITING

Remington-Davis, Inc.

Columbus, Ohio, United States

Site Status RECRUITING

Lynn Health Science Institute

Oklahoma City, Oklahoma, United States

Site Status RECRUITING

Vital Prospects Clinical Research Institute, P.C.

Tulsa, Oklahoma, United States

Site Status RECRUITING

Northwest Research Center

Portland, Oregon, United States

Site Status RECRUITING

Suburban Research Associates

West Chester, Pennsylvania, United States

Site Status RECRUITING

Care Access Research - Warwick 1

Warwick, Rhode Island, United States

Site Status RECRUITING

Lowcountry Lung and Critical Care, P.A.

Charleston, South Carolina, United States

Site Status RECRUITING

Accellacare

Mt. Pleasant, South Carolina, United States

Site Status RECRUITING

Clinical Research of Rock Hill

Rock Hill, South Carolina, United States

Site Status RECRUITING

Internal Medicine and Pediatric Associates of Bristol, PC

Bristol, Tennessee, United States

Site Status RECRUITING

Accellacare d/b/a Accellacare of Knoxville

Knoxville, Tennessee, United States

Site Status RECRUITING

Pharmaceutical Research & Consulting, Inc.

Dallas, Texas, United States

Site Status RECRUITING

Houston Methodist Hospital

Houston, Texas, United States

Site Status RECRUITING

South Texas Allergy & Asthma Medical Professionals

San Antonio, Texas, United States

Site Status RECRUITING

Alamo ENT Associates

San Antonio, Texas, United States

Site Status RECRUITING

TPMG Clinical Research Williamsburg

Williamsburg, Virginia, United States

Site Status RECRUITING

Allergy, Asthma & Sinus Center, SC

Greenfield, Wisconsin, United States

Site Status RECRUITING

UZ Leuven

Leuven, , Belgium

Site Status RECRUITING

AZ Sint-Maarten

Mechelen, , Belgium

Site Status RECRUITING

Pneumocare

Namur, , Belgium

Site Status RECRUITING

AZ Delta

Roeselare, , Belgium

Site Status RECRUITING

Dynamic Drug Advancement

Ajax, Ontario, Canada

Site Status RECRUITING

BLC Clinical Research

Burlington, Ontario, Canada

Site Status RECRUITING

McMaster University

Hamilton, Ontario, Canada

Site Status RECRUITING

Inspiration Research Limited

Toronto, Ontario, Canada

Site Status RECRUITING

Recherche GCP Research

Montreal, Quebec, Canada

Site Status RECRUITING

DIEX Recherche Quebec Inc.

Québec, Quebec, Canada

Site Status RECRUITING

Clinique Specialisee en Allergie de la Capitale

Québec, Quebec, Canada

Site Status RECRUITING

Clinique de pneumologie et du sommeil de Lanaudière

Saint-Charles-Borromée, Quebec, Canada

Site Status ACTIVE_NOT_RECRUITING

DIEX Recherche Sherbrooke Inc.

Sherbrooke, Quebec, Canada

Site Status RECRUITING

DIEX Recherche Victoriaville Inc.

Victoriaville, Quebec, Canada

Site Status RECRUITING

Pneumologisches Studienzentrum Muenchen West

Munich, Bavaria, Germany

Site Status RECRUITING

Lungenzentrum Darmstadt

Darmstadt, Hesse, Germany

Site Status RECRUITING

Medaimun GmbH

Frankfurt am Main, Hesse, Germany

Site Status RECRUITING

Zentrum fuer ambulante pneumologische Forschung Marburg GbR

Marburg, Hesse, Germany

Site Status RECRUITING

Pneumologicum Halle

Halle, Saxony-Anhalt, Germany

Site Status RECRUITING

Pneumologisches Forschungsinstitut Hohegeest GbR

Geesthacht, Schleswig-Holstein, Germany

Site Status RECRUITING

Velocity Research Germany GmbH

Lübeck, Schleswig-Holstein, Germany

Site Status RECRUITING

Pneumologisches Studienzentrum MVZ "Die Lungenärzte"

Berlin, State of Berlin, Germany

Site Status RECRUITING

Prywatny Gabinet Internistyczno-Alergologiczny

Bialystok, , Poland

Site Status RECRUITING

Prywatna Praktyka Lekarska Gabinet Pediatryczno-Alergologiczny

Bialystok, , Poland

Site Status RECRUITING

Centrum Medyczne Pratia Bydgoszcz

Bydgoszcz, , Poland

Site Status RECRUITING

Centrum Medyczne Pratia Czestochowa

Częstochowa, , Poland

Site Status RECRUITING

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

Ostrowiec Świętokrzyski, , Poland

Site Status RECRUITING

Centrum Medyczne Lucyna Andrzej Dymek s.c.

Strzelce Opolskie, , Poland

Site Status RECRUITING

Gabinet Pulmonologii i Diagnostyki Chorób Alergicznych Dorota Maria Małosek

Szczecin, , Poland

Site Status RECRUITING

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

Tarnów, , Poland

Site Status RECRUITING

Ormeau Clinical Trials Ltd

Belfast, Belfast, United Kingdom

Site Status RECRUITING

Belfast City Hospital

Belfast, Belfast, United Kingdom

Site Status RECRUITING

West Walk Surgery

Bristol, Bristol, United Kingdom

Site Status RECRUITING

Castle Hill Hospital

Cottingham, East Riding of Yorkshire, United Kingdom

Site Status RECRUITING

King's College Hospital

London, Greater London, United Kingdom

Site Status RECRUITING

Wythenshawe Hospital

Wythenshawe, Greater Manchester, United Kingdom

Site Status RECRUITING

Nottingham City Hospital

Nottingham, Nottinghamshire, United Kingdom

Site Status RECRUITING

North Tyneside General Hospital

North Shields, Tyne & Wear, United Kingdom

Site Status RECRUITING

Countries

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United States Belgium Canada Germany Poland United Kingdom

Central Contacts

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Nocion Clinical Trials

Role: CONTACT

781-761-2050

Facility Contacts

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Nidal Morrar

Role: primary

Michael Manning

Role: primary

4806758982

William Reedy

Role: primary

6029103343

Karl Sitz

Role: primary

5012241156

Robby Ayoub

Role: primary

7148476900

Warner Carr

Role: primary

9493478700 ext. 117

Mohan, Reddy

Role: primary

4802561321

Ryan Klein

Role: primary

9497918599

Edwin Mangune

Role: primary

5626335101

Rafael Lupercio

Role: primary

Randall Ow

Role: primary

9167363399

James Wolfe

Role: primary

Ricardo Tan

Role: primary

3109669050

Preeti Chopra

Role: primary

3104978815

Joshua Jacobs

Role: primary

9259352599

Timothy Colander

Role: primary

3033719432

Miguel Trevino

Role: primary

2725846368

Kwabena Ayesu

Role: primary

4079881075

Mitchell Rothstein

Role: primary

9047300101

Jose Diaz

Role: primary

Mark Kutner

Role: primary

3056316704

Eddie Armas

Role: primary

3056654818

Amber Pepper

Role: primary

8136314024200

Alfonso Gonzalez Rodriguez

Role: primary

4077408078

Shirish Kirtane

Role: primary

4077887844

Brad Goodman

Role: primary

9123563619

Jaime Villanueva

Role: primary

6305456062

Jason Cascio

Role: primary

5152394400

Matthew Trump

Role: primary

5159793273

Mario Castro

Role: primary

9135887529

William Greisner

Role: primary

8593037191

Lee Clore

Role: primary

2706846144

Matthew Mardiney

Role: primary

4106169566

Curtis Mello

Role: primary

5089983041

Hemalini Mehta

Role: primary

6123332200

Vivek Iyer

Role: primary

5072842158

Christine Franzese

Role: primary

5738828174

Thomas Siler

Role: primary

6369461650

Delores Dotson

Role: primary

3145673377

Jeffrey Tillinghast

Role: primary

3145148509

Richard Sellman

Role: primary

4065491124

Michael Jacobs

Role: primary

7025979825

Keith Brenner

Role: primary

5519962211

Ellen Sher

Role: primary

7326952555111

Joseph Mathew

Role: primary

2125237352

Sherif El Bayadi

Role: primary

3152340816

Alissa McInerney

Role: primary

2126866321

David Cypcar

Role: primary

8282553749

Mikell Jarratt

Role: primary

Lisa Cohen

Role: primary

9197812514

Wilson Jonathan

Role: primary

3367688062

Hassan Yousaf

Role: primary

3366598414

Brian Zeno

Role: primary

6145665000

Carl Griffin

Role: primary

4056023939

Iftikhar Hussain

Role: primary

Subramaniam Seetharaman

Role: primary

5032386233

Omer Abdullah

Role: primary

John Zwetchkenbaum

Role: primary

4013403695

Thomas Kaelin

Role: primary

8435728545

Richard Mills

Role: primary

8438491880

Michael Denenberg

Role: primary

Bernard Grunstra

Role: primary

4239893105

Rickey Manning

Role: primary

8652444276

Gary Gross

Role: primary

2143615555

Lisa Kopas

Role: primary

7132554000

Erika Gonzalez

Role: primary

2102689898

Jeffrey Rosenbloom

Role: primary

2105450404

Richard Parisi

Role: primary

7577073503

Gary Steven

Role: primary

4145298519

Lieven Dupont

Role: primary

+3216346861

Muriel Lins

Role: primary

+3215892040

Jean Benoit Martinot

Role: primary

+32495502608

Ingel Demedts

Role: primary

+3251237216

George Philteos

Role: primary

9054273784

William Patrick Killorn

Role: primary

9056393209

Imran Satia

Role: primary

3658880571

Kenneth Chapman

Role: primary

4169449602

Giuseppe Mazza

Role: primary

51478788915257

Caroline Rheaume

Role: primary

5814773439

Remi Gagnon

Role: primary

4187800881

Ginette Girard

Role: primary

8193462887

Ethel Bellavance

Role: primary

8192601172

Rainald Fischer

Role: primary

+4989880347

Andreas Forster

Role: primary

+496151967810

Stefan Zielen

Role: primary

+4969695958900

Silke Mronga

Role: primary

+496421270723

Peter-Uwe Haase

Role: primary

+4934568698680

Wolfgang Zachgo

Role: primary

Konstanze Landerholm

Role: primary

494517078300

Markus Becker

Role: primary

+493025939380

Zenon Siergiejko

Role: primary

+48856517948

Anna Ploszczuk

Role: primary

48857321361

Jacek Duleba

Role: primary

+48500187267

Elzbieta Janusik

Role: primary

+48501783545

Anna Olech-Cudzik

Role: primary

+48606113167

Andrzej Dymek

Role: primary

+48506185960

Dorota Malosek

Role: primary

+48914895503

Bernadetta Majorek-Olechowska

Role: primary

+48600024455

Damien McNally

Role: primary

+442890278380

Lorcan McGarvey

Role: primary

+447970710309

Samuel Davies

Role: primary

+441454272200

Alyn Morice

Role: primary

+441482624067

Peter Siu Pan Cho

Role: primary

+442032991096

Paul Marsden

Role: primary

+441612915388

Matthew Martin

Role: primary

+441158404844

Sean Parker

Role: primary

+441912934124

Other Identifiers

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NOC110-C-202

Identifier Type: -

Identifier Source: org_study_id

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