Assessing a new treatment for chronic cough in adults
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 study is testing a new inhalation treatment for adults with a stubborn chronic cough to see if it helps them feel better compared to a placebo.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 455 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Nocion Therapeutics Industry-sponsored |
| Locations | 107 sites (Foley, Alabama and 106 other locations) |
| Trial ID | NCT06504446 on ClinicalTrials.gov |
What this trial studies
This phase 2b clinical trial evaluates the efficacy, safety, and tolerability of NOC-110, an inhalation powder, in adults suffering from refractory or unexplained chronic cough. Approximately 325 participants will be enrolled, with an anticipated screening of up to 600 individuals. The study will be randomized, double-blind, and placebo-controlled, lasting about 13 weeks. Participants will receive either the active treatment or a placebo once daily.
Who should consider this trial
Good fit: Ideal candidates are adults with a chronic cough lasting 12 months or more that is refractory or unexplained.
Not a fit: Patients with chronic obstructive pulmonary disease, bronchiectasis, or other significant pulmonary diseases will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly alleviate chronic cough symptoms for patients who have not responded to other therapies.
How similar studies have performed: While this approach is novel, similar studies targeting chronic cough have shown varying degrees of success.
Eligibility criteria
Show full inclusion / exclusion criteria
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).
Where this trial is running
Foley, Alabama and 106 other locations
- G & L Research, LLC — Foley, Alabama, United States (Recruiting)
- Medical Research of Arizona — Scottsdale, Arizona, United States (Recruiting)
- AMR Phoenix — Tempe, Arizona, United States (Recruiting)
- Little Rock Allergy & Asthma, P.A. Clinical Research Center — Little Rock, Arkansas, United States (Recruiting)
- So Cal Clinical Research — Huntington Beach, California, United States (Recruiting)
- Allergy and Asthma Associates of Southern California dba Southern California Research — Laguna Niguel, California, United States (Recruiting)
- Paradigm Clinical Research Centers, LLC - Modesto — Modesto, California, United States (Recruiting)
- NewportNativeMD,Inc — Newport Beach, California, United States (Recruiting)
- Center for Clinical Trials, LLC — Paramount, California, United States (Recruiting)
- Paradigm Clinical Research Centers, LLC — Redding, California, United States (Recruiting)
- DaVinci Research LLC. — Roseville, California, United States (Recruiting)
- Allergy & Asthma Associates of Santa Clara Valley — San Jose, California, United States (Recruiting)
- California Allergy & Asthma Medical Group Inc. — San Jose, California, United States (Recruiting)
- Allergy, Asthma, and Immunology Medical Group — Ventura, California, United States (Recruiting)
- Allergy and Asthma Clinical Research Inc — Walnut Creek, California, United States (Recruiting)
- Lynn Institute of Denver — Aurora, Colorado, United States (Recruiting)
- Innovative Research of West Florida, Inc. — Clearwater, Florida, United States (Recruiting)
- Omega Research Debary, LLC — DeBary, Florida, United States (Recruiting)
- Jacksonville Center for Clinical Research — Jacksonville, Florida, United States (Recruiting)
- Clinical Site Partners, LLC Leesburg dba Flourish Research — Leesburg, Florida, United States (Recruiting)
- Suncoast Research Group, LLC Miami - Little Havana dba Flourish Research — Miami, Florida, United States (Recruiting)
- Well Pharma Medical Research Corporation — Miami, Florida, United States (Recruiting)
- University of South Florida - PARENT — Tampa, Florida, United States (Recruiting)
- Clinical Site Partners, LLC Orlando dba Flourish Research — Winter Park, Florida, United States (Recruiting)
- Clinical Site Partners, LLC Orlando dba Flourish Research — Winter Park, Florida, United States (Recruiting)
- Aeroallergy Research Laboratories of Savannah, Inc. — Savannah, Georgia, United States (Recruiting)
- Duly Health and Care — Winfield, Illinois, United States (Recruiting)
- Accellacare of McFarland Clinic — Ames, Iowa, United States (Recruiting)
- The Iowa Clinic, PC — West Des Moines, Iowa, United States (Recruiting)
- University of Kansas Medical Center — Kansas City, Kansas, United States (Recruiting)
- Bluegrass Allergy Research — Lexington, Kentucky, United States (Recruiting)
- Allergy & Asthma Specialists, PSC — Owensboro, Kentucky, United States (Recruiting)
- Continental Clinical Solutions, LLC — Towson, Maryland, United States (Recruiting)
- Infinity Medical Research Inc — Russells Mills, Massachusetts, United States (Recruiting)
- Clinical Research Institute — Minneapolis, Minnesota, United States (Recruiting)
- Mayo Clinic - Rochester — Rochester, Minnesota, United States (Recruiting)
- The Curators of the University of Missouri on behalf of University of Missouri Health Care — Columbia, Missouri, United States (Recruiting)
- Midwest Chest Consultants — Saint Charles, Missouri, United States (Recruiting)
- Sundance Clinical Research — St Louis, Missouri, United States (Terminated)
- The Clinical Research Center, LLC — St Louis, Missouri, United States (Recruiting)
- Montana Medical Research, Inc. — Missoula, Montana, United States (Recruiting)
- AMR Las Vegas — Las Vegas, Nevada, United States (Recruiting)
- Hackensack University Medical Center — Hackensack, New Jersey, United States (Recruiting)
- Allergy Partners of New Jersey P C — Ocean City, New Jersey, United States (Recruiting)
- The Valley Hospital — Paramus, New Jersey, United States (Recruiting)
- St Josephs Physicians Med PC Pulmonary Health — Liverpool, New York, United States (Recruiting)
- Equity Medical LLC — New York, New York, United States (Recruiting)
- Allergy Partners Clinical Research — Asheville, North Carolina, United States (Recruiting)
- Clinical Research of Gastonia — Gastonia, North Carolina, United States (Recruiting)
- M3 Wake Research, Inc. — Raleigh, North Carolina, United States (Recruiting)
+57 more sites — see ClinicalTrials.gov for the full list.
Study contacts
- Study coordinator: Nocion Clinical Trials
- Email: clinicaltrials@nociontx.com
- Phone: 781-761-2050
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.