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Refractory or Unexplained Chronic CoughPhase 2ASPIRENCT06504446

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

A Phase 2 study testing NOC-110 in people with Refractory or Unexplained Chronic Cough, run by Nocion Therapeutics at 106 sites in 6 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Refractory or Unexplained Chronic Cough
What is being tested?
NOC-110
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
455 participants
Where
106 sitesin 6 countries
Study dates
24 Sep 2024to 29 Jun 2026
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 15Show fewer
  • 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).

Trial locations and contacts

106 sites in 6 countries.

106 sites in 6 countries

United States68 sites

  • Accellacare of McFarland Clinic

    Ames, Iowa, 50010

  • Allergy Partners Clinical Research

    Asheville, North Carolina, 28803

  • Lynn Institute of Denver

    Aurora, Colorado, 80012

  • Internal Medicine and Pediatric Associates of Bristol, PC

    Bristol, Tennessee, 37620

  • Lowcountry Lung and Critical Care, P.A.

    Charleston, South Carolina, 29406

  • Innovative Research of West Florida, Inc.

    Clearwater, Florida, 33756

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

    Columbia, Missouri, 65212

  • Remington-Davis, Inc.

    Columbus, Ohio, 43215

  • Pharmaceutical Research & Consulting, Inc.

    Dallas, Texas, 75231

  • Omega Research Debary, LLC

    DeBary, Florida, 32713

  • G & L Research, LLC

    Foley, Alabama, 36535

  • Clinical Research of Gastonia

    Gastonia, North Carolina, 28054

  • Allergy, Asthma & Sinus Center, SC

    Greenfield, Wisconsin, 53228

  • Hackensack University Medical Center

    Hackensack, New Jersey, 07601

  • Houston Methodist Hospital

    Houston, Texas, 77030

  • So Cal Clinical Research

    Huntington Beach, California, 92647

  • Jacksonville Center for Clinical Research

    Jacksonville, Florida, 32216

  • University of Kansas Medical Center

    Kansas City, Kansas, 66160

  • Accellacare d/b/a Accellacare of Knoxville

    Knoxville, Tennessee, 37938

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

    Laguna Niguel, California, 92677

  • AMR Las Vegas

    Las Vegas, Nevada, 89119

  • Clinical Site Partners, LLC Leesburg dba Flourish Research

    Leesburg, Florida, 34748

  • Bluegrass Allergy Research

    Lexington, Kentucky, 40509

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

    Little Rock, Arkansas, 72205

  • St Josephs Physicians Med PC Pulmonary Health

    Liverpool, New York, 13088

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

    Miami, Florida, 33135

  • Well Pharma Medical Research Corporation

    Miami, Florida, 33173

  • Clinical Research Institute

    Minneapolis, Minnesota, 55402

  • Montana Medical Research, Inc.

    Missoula, Montana, 59808

  • Paradigm Clinical Research Centers, LLC - Modesto

    Modesto, California, 95355

  • Accellacare

    Mt. Pleasant, South Carolina, 29464

  • Equity Medical LLC

    New York, New York, 10023

  • NewportNativeMD,Inc

    Newport Beach, California, 92663

  • Allergy Partners of New Jersey P C

    Ocean City, New Jersey, 07712

  • Lynn Health Science Institute

    Oklahoma City, Oklahoma, 73112

  • Allergy & Asthma Specialists, PSC

    Owensboro, Kentucky, 42301

  • Center for Clinical Trials, LLC

    Paramount, California, 90723

  • The Valley Hospital

    Paramus, New Jersey, 07652

  • Northwest Research Center

    Portland, Oregon, 97202

  • M3 Wake Research, Inc.

    Raleigh, North Carolina, 27612

  • Paradigm Clinical Research Centers, LLC

    Redding, California, 96001

  • Mayo Clinic - Rochester

    Rochester, Minnesota, 55905

  • Clinical Research of Rock Hill

    Rock Hill, South Carolina, 29732

  • DaVinci Research LLC.

    Roseville, California, 95661

  • Infinity Medical Research Inc

    Russells Mills, Massachusetts, 02747

  • Midwest Chest Consultants

    Saint Charles, Missouri, 63301

  • South Texas Allergy & Asthma Medical Professionals

    San Antonio, Texas, 78229

  • Alamo ENT Associates

    San Antonio, Texas, 78258

  • Allergy & Asthma Associates of Santa Clara Valley

    San Jose, California, 95117

  • California Allergy & Asthma Medical Group Inc.

    San Jose, California, 95117

  • Aeroallergy Research Laboratories of Savannah, Inc.

    Savannah, Georgia, 31406

  • Medical Research of Arizona

    Scottsdale, Arizona, 85251

  • Sundance Clinical Research

    St Louis, Missouri, 63141

  • The Clinical Research Center, LLC

    St Louis, Missouri, 63141

  • University of South Florida - PARENT

    Tampa, Florida, 33613

  • AMR Phoenix

    Tempe, Arizona, 85281

  • Continental Clinical Solutions, LLC

    Towson, Maryland, 21204

  • Vital Prospects Clinical Research Institute, P.C.

    Tulsa, Oklahoma, 74136

  • Allergy, Asthma, and Immunology Medical Group

    Ventura, California, 93003

  • Allergy and Asthma Clinical Research Inc

    Walnut Creek, California, 94598

  • Care Access Research - Warwick 1

    Warwick, Rhode Island, 02886

  • Suburban Research Associates

    West Chester, Pennsylvania, 19380

  • The Iowa Clinic, PC

    West Des Moines, Iowa, 50266

  • TPMG Clinical Research Williamsburg

    Williamsburg, Virginia, 23188

  • Duly Health and Care

    Winfield, Illinois, 60190

  • Accellacare

    Winston-Salem, North Carolina, 27103

  • Southeastern Research Center LLC

    Winston-Salem, North Carolina, 27103

  • Clinical Site Partners, LLC Orlando dba Flourish Research

    Winter Park, Florida, 32789

Other trials in United States

Canada10 sites

  • Dynamic Drug Advancement

    Ajax, Ontario, L1S 2J5

  • BLC Clinical Research

    Burlington, Ontario, L7N 3V2

  • McMaster University

    Hamilton, Ontario, L8N 3Z5

  • Recherche GCP Research

    Montreal, Quebec, H1Y 3H5

  • DIEX Recherche Quebec Inc.

    Québec, Quebec, G1V 4T3

  • Clinique Specialisee en Allergie de la Capitale

    Québec, Quebec, G1V 4W2

  • Clinique de pneumologie et du sommeil de Lanaudière

    Saint-Charles-Borromée, Quebec, J6E 2B4

  • DIEX Recherche Sherbrooke Inc.

    Sherbrooke, Quebec, J1L 0H8

  • Inspiration Research Limited

    Toronto, Ontario, M5T 3A9

  • DIEX Recherche Victoriaville Inc.

    Victoriaville, Quebec, G6P 3Z8

Other trials in Canada

Germany8 sites

  • Pneumologisches Studienzentrum MVZ "Die Lungenärzte"

    Berlin, State of Berlin, 10961

  • Lungenzentrum Darmstadt

    Darmstadt, Hesse, 64283

  • Medaimun GmbH

    Frankfurt am Main, Hesse, 60596

  • Pneumologisches Forschungsinstitut Hohegeest GbR

    Geesthacht, Schleswig-Holstein

  • Pneumologicum Halle

    Halle, Saxony-Anhalt, 06108

  • Velocity Research Germany GmbH

    Lübeck, Schleswig-Holstein, 23552

  • Zentrum fuer ambulante pneumologische Forschung Marburg GbR

    Marburg, Hesse, 35037

  • Pneumologisches Studienzentrum Muenchen West

    Munich, Bavaria, 81241

Other trials in Germany

Poland8 sites

  • Prywatny Gabinet Internistyczno-Alergologiczny

    Bialystok, 15-010

  • Prywatna Praktyka Lekarska Gabinet Pediatryczno-Alergologiczny

    Bialystok, 15-430

  • Centrum Medyczne Pratia Bydgoszcz

    Bydgoszcz, 85-796

  • Centrum Medyczne Pratia Czestochowa

    Częstochowa, 42-217

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

    Ostrowiec Świętokrzyski, 27-400

  • Centrum Medyczne Lucyna Andrzej Dymek s.c.

    Strzelce Opolskie, 47-100

  • Gabinet Pulmonologii i Diagnostyki Chorób Alergicznych Dorota Maria Małosek

    Szczecin, 70-1111

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

    Tarnów, 33-100

Other trials in Poland

United Kingdom8 sites

  • Ormeau Clinical Trials Ltd

    Belfast, Belfast, BT2 8BG

  • Belfast City Hospital

    Belfast, Belfast, BT9 7AB

  • West Walk Surgery

    Bristol, Bristol, BS374AX

  • Castle Hill Hospital

    Cottingham, East Riding of Yorkshire, HU16 5JQ

  • King's College Hospital

    London, Greater London, SE5 9RS

  • North Tyneside General Hospital

    North Shields, Tyne & Wear, NE29 8NH

  • Nottingham City Hospital

    Nottingham, Nottinghamshire, NG56EG

  • Wythenshawe Hospital

    Wythenshawe, Greater Manchester, M23 9LT

Other trials in United Kingdom

Belgium4 sites

  • UZ Leuven

    Leuven, 3000

  • AZ Sint-Maarten

    Mechelen, 2800

  • Pneumocare

    Namur, 5380

  • AZ Delta

    Roeselare, 8800

Other trials in Belgium

About this study

Official title: 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.

Read the 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.

Being tested
NOC-110, Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NOC-110Drug

    Also called taplucainium

    Inhalation powder

  • PlaceboOther

    Inhalation powder

Study groups in NCT06504446
Study groupRoleWhat they receive
NOC-110 1mgExperimentalNOC-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.
Receives: Drug: NOC-110
NOC-110 3mgExperimentalNOC-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.
Receives: Drug: NOC-110
NOC-110 6mgExperimentalNOC-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.
Receives: Drug: NOC-110
PlaceboPlacebo comparatorThe 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.
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline to End of Treatment

Secondary outcomes (6)

  1. Change in Awake coughs per hour from Baseline

    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.

    Measured: Baseline to End of Treatment

  2. Change in the Cough Severity Visual Analog Scale from Baseline

    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."

    Measured: Baseline to End of Treatment

  3. Change in the Urge to Cough Visual Analog Scale from Baseline

    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."

    Measured: Baseline to End of Treatment

  4. Change in the Leicester Cough Questionnaire from Baseline

    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.

    Measured: Baseline to End of Treatment

  5. Patient Global Impressions of Improvement score

    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.

    Measured: End of Treatment

  6. Incidence and severity of adverse events and serious adverse events

    Measured: Baseline to End of Treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Jul 2024
  2. Study start24 Sep 2024
  3. Primary completion15 Jun 2026 (estimated)
  4. Study completion29 Jun 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Sequential
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
455 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06504446
Sponsor's protocol ID
NOC110-C-202
Acronym
ASPIRE
Status last verified
Jun 2026
First submitted
11 Jul 2024
Last updated
11 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing NOC-110 in people with Refractory or Unexplained Chronic Cough, run by Nocion Therapeutics at 106 sites in 6 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 11 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 106 sites in United States, Canada, Germany, Poland, United Kingdom and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in 24-hour Coughs per hour from Baseline (time frame: Baseline to End of Treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06504446.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2026.

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