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

February 13, 2026 updated by: Nocion Therapeutics

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

455

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Belgium
      • Leuven, Belgium, 3000
      • Mechelen, Belgium, 2800
      • Namur, Belgium, 5380
        • Recruiting
        • Pneumocare
        • Contact:
      • Roeselare, Belgium, 8800
  • Canada
    • Ontario
      • Ajax, Ontario, Canada, L1S 2J5
      • Burlington, Ontario, Canada, L7N 3V2
        • Recruiting
        • BLC Clinical Research
        • Contact:
      • Hamilton, Ontario, Canada, L8N 3Z5
        • Recruiting
        • McMaster University
        • Contact:
      • Toronto, Ontario, Canada, M5T 3A9
    • Quebec
      • Montreal, Quebec, Canada, H1Y 3H5
      • Québec, Quebec, Canada, G1V 4T3
        • Recruiting
        • Diex Recherche Quebec Inc.
        • Contact:
      • Québec, Quebec, Canada, G1V 4W2
        • Recruiting
        • Clinique Spécialisée en Allergie de la Capitale
        • Contact:
      • Saint-Charles-Borromée, Quebec, Canada, J6E 2B4
        • Terminated
        • Clinique de pneumologie et du sommeil de Lanaudiere
      • Sherbrooke, Quebec, Canada, J1L 0H8
        • Recruiting
        • DIEX Recherche Sherbrooke Inc.
        • Contact:
      • Victoriaville, Quebec, Canada, G6P 3Z8
        • Recruiting
        • Diex Recherche Victoriaville Inc.
        • Contact:
  • Germany
    • Bavaria
      • Munich, Bavaria, Germany, 81241
        • Recruiting
        • Pneumologisches Studienzentrum Muenchen West
        • Contact:
    • Hesse
      • Darmstadt, Hesse, Germany, 64283
      • Frankfurt am Main, Hesse, Germany, 60596
        • Recruiting
        • Medaimun GmbH
        • Contact:
      • Marburg, Hesse, Germany, 35037
        • Recruiting
        • Zentrum fuer ambulante pneumologische Forschung Marburg GbR
        • Contact:
    • Saxony-Anhalt
      • Halle, Saxony-Anhalt, Germany, 06108
        • Recruiting
        • Pneumologicum Halle
        • Contact:
    • Schleswig-Holstein
      • Geesthacht, Schleswig-Holstein, Germany
      • Lübeck, Schleswig-Holstein, Germany, 23552
    • State of Berlin
      • Berlin, State of Berlin, Germany, 10961
        • Recruiting
        • Pneumologisches Studienzentrum MVZ "Die Lungenärzte"
        • Contact:
  • Poland
      • Bialystok, Poland, 15-010
        • Recruiting
        • Prywatny Gabinet Internistyczno-Alergologiczny
        • Contact:
      • Bialystok, Poland, 15-430
        • Recruiting
        • Prywatna Praktyka Lekarska Gabinet Pediatryczno-Alergologiczny
        • Contact:
      • Bydgoszcz, Poland, 85-796
        • Recruiting
        • Centrum Medyczne PRATIA Bydgoszcz
        • Contact:
      • Częstochowa, Poland, 42-217
        • Recruiting
        • Centrum Medyczne Pratia Częstochowa
        • Contact:
      • Ostrowiec Świętokrzyski, Poland, 27-400
        • Recruiting
        • Ostrowieckie Centrum Medyczne Spółka Cywilna Anna Olech-Cudzik, Krzysztof Cudzik
        • Contact:
      • Strzelce Opolskie, Poland, 47-100
        • Recruiting
        • Centrum Medyczne Lucyna Andrzej Dymek s.c.
        • Contact:
      • Szczecin, Poland, 70-1111
        • Recruiting
        • Gabinet Pulmonologii i Diagnostyki Chorób Alergicznych Dorota Maria Małosek
        • Contact:
      • Tarnów, Poland, 33-100
        • Recruiting
        • Alergo-Med Specjalistyczna Przychodnia Lekarska Sp. Z .O.O.
        • Contact:
  • United Kingdom
    • Belfast
      • Belfast, Belfast, United Kingdom, BT2 8BG
      • Belfast, Belfast, United Kingdom, BT9 7AB
        • Recruiting
        • Belfast City Hospital
        • Contact:
    • Bristol
      • Bristol, Bristol, United Kingdom, BS374AX
        • Recruiting
        • West Walk Surgery
        • Contact:
    • East Riding of Yorkshire
      • Cottingham, East Riding of Yorkshire, United Kingdom, HU16 5JQ
        • Recruiting
        • Castle Hill Hospital
        • Contact:
    • Greater London
      • London, Greater London, United Kingdom, SE5 9RS
        • Recruiting
        • King's College Hospital
        • Contact:
          • Peter Siu Pan Cho
          • Phone Number: +442032991096
          • Email: p.cho@nhs.net
    • Greater Manchester
      • Wythenshawe, Greater Manchester, United Kingdom, M23 9LT
    • Nottinghamshire
      • Nottingham, Nottinghamshire, United Kingdom, NG56EG
        • Recruiting
        • Nottingham City Hospital
        • Contact:
    • Tyne & Wear
      • North Shields, Tyne & Wear, United Kingdom, NE29 8NH
  • United States
    • Alabama
      • Foley, Alabama, United States, 36535
        • Recruiting
        • G & L Research, LLC
        • Contact:
          • Nidal Morrar
    • Arizona
      • Scottsdale, Arizona, United States, 85251
        • Recruiting
        • Medical Research of Arizona
        • Contact:
      • Tempe, Arizona, United States, 85281
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • Recruiting
        • Little Rock Allergy & Asthma, P.A. Clinical Research Center
        • Contact:
    • California
      • Huntington Beach, California, United States, 92647
      • Laguna Niguel, California, United States, 92677
        • Recruiting
        • Allergy and Asthma Associates of Southern California dba Southern California Research
        • Contact:
      • Modesto, California, United States, 95355
        • Recruiting
        • Paradigm Clinical Research Centers, LLC - Modesto
        • Contact:
      • Newport Beach, California, United States, 92663
      • Paramount, California, United States, 90723
        • Recruiting
        • Center for Clinical Trials, LLC
        • Contact:
      • Redding, California, United States, 96001
        • Recruiting
        • Paradigm Clinical Research Centers, LLC
        • Contact:
          • Rafael Lupercio
      • Roseville, California, United States, 95661
        • Recruiting
        • DaVinci Research LLC.
        • Contact:
      • San Jose, California, United States, 95117
        • Recruiting
        • Allergy & Asthma Associates of Santa Clara Valley
        • Contact:
          • James Wolfe
      • San Jose, California, United States, 95117
        • Recruiting
        • California Allergy & Asthma Medical Group Inc.
        • Contact:
      • Ventura, California, United States, 93003
        • Recruiting
        • Allergy, Asthma, and Immunology Medical Group
        • Contact:
      • Walnut Creek, California, United States, 94598
        • Recruiting
        • Allergy and Asthma Clinical Research Inc
        • Contact:
    • Colorado
      • Aurora, Colorado, United States, 80012
        • Recruiting
        • Lynn Institute of Denver
        • Contact:
    • Florida
      • Clearwater, Florida, United States, 33756
      • DeBary, Florida, United States, 32713
        • Recruiting
        • Omega Research Debary, LLC
        • Contact:
      • Jacksonville, Florida, United States, 32216
        • Recruiting
        • Jacksonville Center for Clinical Research
        • Contact:
      • Leesburg, Florida, United States, 34748
      • Miami, Florida, United States, 33173
        • Recruiting
        • Well Pharma Medical Research Corporation
        • Contact:
      • Miami, Florida, United States, 33135
        • Recruiting
        • Suncoast Research Group, LLC Miami - Little Havana dba Flourish Research
        • Contact:
      • Tampa, Florida, United States, 33613
        • Recruiting
        • University of South Florida - PARENT
        • Contact:
      • Winter Park, Florida, United States, 32789
        • Recruiting
        • Clinical Site Partners, LLC Orlando dba Flourish Research
        • Contact:
    • Georgia
      • Savannah, Georgia, United States, 31406
        • Recruiting
        • Aeroallergy Research Laboratories of Savannah, Inc.
        • Contact:
    • Illinois
      • Winfield, Illinois, United States, 60190
    • Iowa
      • Ames, Iowa, United States, 50010
      • West Des Moines, Iowa, United States, 50266
        • Recruiting
        • The Iowa Clinic, PC
        • Contact:
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • Recruiting
        • University of Kansas Medical Center
        • Contact:
    • Kentucky
      • Lexington, Kentucky, United States, 40509
        • Recruiting
        • Bluegrass Allergy Research
        • Contact:
      • Owensboro, Kentucky, United States, 42301
        • Recruiting
        • Allergy & Asthma Specialists, PSC
        • Contact:
    • Maryland
      • Towson, Maryland, United States, 21204
    • Massachusetts
      • Russells Mills, Massachusetts, United States, 02747
    • Minnesota
      • Minneapolis, Minnesota, United States, 55402
      • Rochester, Minnesota, United States, 55905
        • Recruiting
        • Mayo Clinic - Rochester
        • Contact:
    • Missouri
      • Columbia, Missouri, United States, 65212
        • Recruiting
        • The Curators of the University of Missouri on behalf of University of Missouri Health Care
        • Contact:
      • Saint Charles, Missouri, United States, 63301
      • St Louis, Missouri, United States, 63141
      • St Louis, Missouri, United States, 63141
        • Terminated
        • Sundance Clinical Research
    • Montana
      • Missoula, Montana, United States, 59808
    • Nevada
      • Las Vegas, Nevada, United States, 89119
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • Recruiting
        • Hackensack University Medical Center
        • Contact:
      • Ocean City, New Jersey, United States, 07712
      • Paramus, New Jersey, United States, 07652
    • New York
      • Liverpool, New York, United States, 13088
        • Recruiting
        • St Josephs Physicians Med PC Pulmonary Health
        • Contact:
      • New York, New York, United States, 10023
    • North Carolina
      • Asheville, North Carolina, United States, 28803
      • Gastonia, North Carolina, United States, 28054
        • Recruiting
        • Clinical Research of Gastonia
        • Contact:
          • Mikell Jarratt
      • Raleigh, North Carolina, United States, 27612
      • Winston-Salem, North Carolina, United States, 27103
      • Winston-Salem, North Carolina, United States, 27103
    • Ohio
      • Columbus, Ohio, United States, 43215
        • Terminated
        • Remington-Davis, Inc.
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73112
        • Recruiting
        • Lynn Health Science Institute
        • Contact:
      • Tulsa, Oklahoma, United States, 74136
        • Recruiting
        • Vital Prospects Clinical Research Institute, P.C.
        • Contact:
          • Iftikhar Hussain
    • Oregon
      • Portland, Oregon, United States, 97202
    • Pennsylvania
      • West Chester, Pennsylvania, United States, 19380
    • Rhode Island
      • Warwick, Rhode Island, United States, 02886
        • Recruiting
        • Care Access Research - Warwick 1
        • Contact:
    • South Carolina
      • Charleston, South Carolina, United States, 29406
        • Recruiting
        • Lowcountry Lung and Critical Care, P.A.
        • Contact:
      • Mt. Pleasant, South Carolina, United States, 29464
      • Rock Hill, South Carolina, United States, 29732
        • Recruiting
        • Clinical Research of Rock Hill
        • Contact:
          • Michael Denenberg
    • Tennessee
      • Bristol, Tennessee, United States, 37620
        • Recruiting
        • Internal Medicine and Pediatric Associates of Bristol, PC
        • Contact:
      • Knoxville, Tennessee, United States, 37938
    • Texas
      • Dallas, Texas, United States, 75231
        • Recruiting
        • Pharmaceutical Research & Consulting, Inc.
        • Contact:
      • Houston, Texas, United States, 77030
      • San Antonio, Texas, United States, 78258
      • San Antonio, Texas, United States, 78229
        • Recruiting
        • South Texas Allergy & Asthma Medical Professionals
        • Contact:
    • Virginia
      • Williamsburg, Virginia, United States, 23188
        • Recruiting
        • TPMG Clinical Research Williamsburg
        • Contact:
    • Wisconsin
      • Greenfield, Wisconsin, United States, 53228
        • Recruiting
        • Allergy, Asthma & Sinus Center, SC
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Other: Placebo
Inhalation powder
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.
Drug: NOC-110
Inhalation powder
Other Names:
  • taplucainium
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.
Drug: NOC-110
Inhalation powder
Other Names:
  • taplucainium
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.
Drug: NOC-110
Inhalation powder
Other Names:
  • taplucainium

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in 24-hour Coughs per hour from Baseline
Time Frame: Baseline to End of Treatment
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Awake coughs per hour from Baseline
Time Frame: Baseline to End of Treatment
Change in Awake 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
Change in the Cough Severity Visual Analog Scale from Baseline
Time Frame: Baseline to End of Treatment
Visual Analogue Scales for Cough Severity (CS-VAS) will be performed as outlined in the Schedule of Assessments. Participants rate the severity of their cough by marking on the horizontal line their cough severity, with the extreme left side of the line represents "no cough" and the extreme right side of the line representing "worst cough."
Baseline to End of Treatment
Change in the Urge to Cough Visual Analog Scale from Baseline
Time Frame: Baseline to End of Treatment
Urge to Cough Analogue Scales for Cough Severity (UC-VAS) will be performed as outlined in the Schedule of Assessments. Participants rate the severity of their cough by marking on the horizontal line their cough severity, with the extreme left side of the line represents "no cough" and the extreme right side of the line representing "worst cough."
Baseline to End of Treatment
Change in the Leicester Cough Questionnaire from Baseline
Time Frame: Baseline to End of Treatment
Leicester Cough Questionnaire (LCQ) is a validated cough-specific quality of life measure that evaluates the impact of cough across 3 domains: physical, psychological, and social. The LCQ is a 19-item questionnaire with each item scored using a 7-point Likert scale ranging from 1 = all the time to 7=none of the time. The total severity score ranges from 3-21, with a lower score indicating greater impairment of health status due to cough.
Baseline to End of Treatment
Patient Global Impressions of Improvement score
Time Frame: End of Treatment
Patient Global Impressions of Improvement (PGI-I) is used to assess improvement or worsening of the Participants status in relation to the therapeutic area of interest. The main purpose of the scale is to quantify the extent to which the participant has improved or deteriorated over time. The PGI-I is a 7-point Likert scale ranging from 1=Very Much Better to 7=Very Much Worse.
End of Treatment
Incidence and severity of adverse events and serious adverse events
Time Frame: Baseline to End of Treatment
Baseline to End of Treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nocion Therapeutics

Collaborators

IQVIA Pty Ltd

Investigators

  • Study Director: Matthew Frankel, MD, Chief Medical Officer Nocion Therapeutics, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 24, 2024

Primary Completion (Estimated)

April 10, 2026

Study Completion (Estimated)

April 10, 2026

Study Registration Dates

First Submitted

July 11, 2024

First Submitted That Met QC Criteria

July 11, 2024

First Posted (Actual)

July 16, 2024

Study Record Updates

Last Update Posted (Actual)

February 17, 2026

Last Update Submitted That Met QC Criteria

February 13, 2026

Last Verified

November 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NOC110-C-202

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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