RECRUITING

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

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Conditions

Refractory or Unexplained Chronic Cough

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2024-09-24
Study Completion:2025-11-10
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06504446

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.

Ages Eligible for Study:18 Years to 80 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Refractory or unexplained chronic cough for ≥ 12 months.
  2. * Women of childbearing potential agree to follow the protocol specified contraceptive - guidance during the study.
  3. * Males who are not vasectomized must agree to use the contraceptive methods defined in the protocol.
  4. * Able to provide Informed Consent.
  1. * Previous exposure to taplucainium (formerly NTX-1175) or known allergy or hypersensitivity to taplucainium, its excipients/metabolites, or related compounds.
  2. * Participants who are currently participating in another drug or device clinical study
  3. * Participants who have participated in an Acute or Chronic Cough investigational study within 60 days before the start of the Screening.
  4. * Current diagnosis of chronic obstructive pulmonary disease, bronchiectasis, unexplained pulmonary fibrosis, hemoptysis, bronchial asthma (not including resolved childhood asthma), or other pulmonary disease.
  5. * Respiratory tract infection within 4 weeks of Screening.
  6. * Any female who is pregnant or lactating or wishing to become pregnant.
  7. * Donation of \> 1 Unit (450 milliliter or more) of blood within 90 days prior to the first dosing.
  8. * Alcohol or drug use disorder within the past 2 years.
  9. * Current smoker/vaper or individuals who have given up smoking within the past 6 months, and/or those with \>20 pack-year smoking history.
  10. * 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.
  11. * Body Mass Index of ≥40 kg/m2.
  12. * Positive results for human immunodeficiency virus, hepatitis B, or hepatitis C virus.
  13. * Unable to refrain from the use of medications and treatments that can impact cough during the study.
  14. * Have clinically significant history or evidence of poorly controlled cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, neurological, immunological, or psychiatric disorder(s).

Contacts and Locations

Study Contact

Nocion Clinical Trials
CONTACT
781-761-2050
clinicaltrials@nociontx.com

Principal Investigator

Bernard L Silverman, MD
STUDY_DIRECTOR
Chief Medical Officer Nocion Therapeutics, Inc.

Study Locations (Sites)

G & L Research, LLC
Foley, Alabama, 36535
United States
AMR Phoenix
Tempe, Arizona, 85281
United States
Little Rock Allergy & Asthma, P.A. Clinical Research Center
Little Rock, Arkansas, 72205
United States
Allergy and Asthma Associates of Southern California dba Southern California Research
Laguna Niguel, California, 92677
United States
NewportNativeMD,Inc
Newport Beach, California, 92663
United States
Paradigm Clinical Research Centers, LLC
Redding, California, 96001
United States
Allergy & Asthma Associates of Santa Clara Valley
San Jose, California, 95117
United States
California Allergy & Asthma Medical Group Inc.
San Jose, California, 95117
United States
Allergy and Asthma Clinical Research Inc
Walnut Creek, California, 94598
United States
Innovative Research of West Florida, Inc.
Clearwater, Florida, 33756
United States
Omega Research Debary, LLC
DeBary, Florida, 32713
United States
Clinical Site Partners, LLC Leesburg dba Flourish Research
Leesburg, Florida, 34748
United States
Suncoast Research Group, LLC Miami - Little Havana dba Flourish Research
Miami, Florida, 33135
United States
Well Pharma Medical Research Corporation
Miami, Florida, 33173
United States
Clinical Site Partners, LLC Orlando dba Flourish Research
Winter Park, Florida, 32789
United States
Duly Health and Care
Winfield, Illinois, 60190
United States
Accellacare of McFarland Clinic
Ames, Iowa, 50010
United States
Bluegrass Allergy Research
Lexington, Kentucky, 40509
United States
Allergy & Asthma Specialists, PSC
Owensboro, Kentucky, 42301
United States
Clinical Research Institute
Minneapolis, Minnesota, 55402
United States
Midwest Chest Consultants
Saint Charles, Missouri, 63301
United States
Sundance Clinical Research
Saint Louis, Missouri, 63141
United States
The Clinical Research Center, LLC
Saint Louis, Missouri, 63141
United States
Montana Medical Research, Inc.
Missoula, Montana, 59808
United States
Clinical Research of Gastonia
Gastonia, North Carolina, 28054
United States
Accellacare
Winston-Salem, North Carolina, 27103
United States
Remington-Davis, Inc.
Columbus, Ohio, 43215
United States
Lynn Health Science Institute
Oklahoma City, Oklahoma, 73112
United States
Vital Prospects Clinical Research Institute, P.C.
Tulsa, Oklahoma, 74136
United States
Northwest Research Center
Portland, Oregon, 97202
United States
Care Access Research - Warwick 1
Warwick, Rhode Island, 02886
United States
Lowcountry Lung and Critical Care, P.A.
Charleston, South Carolina, 29406
United States
Accellacare
Mount Pleasant, South Carolina, 29464
United States
National Allergy and Asthma Research, LLC
North Charleston, South Carolina, 29420
United States
Clinical Research of Rock Hill
Rock Hill, South Carolina, 29732
United States
Internal Medicine and Pediatric Associates of Bristol, PC
Bristol, Tennessee, 37620
United States
Pharmaceutical Research & Consulting, Inc.
Dallas, Texas, 75231
United States
South Texas Allergy & Asthma Medical Professionals
San Antonio, Texas, 78229
United States
Allergy, Asthma & Sinus Center, SC
Greenfield, Wisconsin, 53228
United States

Collaborators and Investigators

Sponsor: Nocion Therapeutics

  • Bernard L Silverman, MD, STUDY_DIRECTOR, 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 Registration Dates

Study Start Date2024-09-24
Study Completion Date2025-11-10

Study Record Updates

Study Start Date2024-09-24
Study Completion Date2025-11-10

Terms related to this study

Additional Relevant MeSH Terms

  • Refractory or Unexplained Chronic Cough