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

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.

Conditions

Refractory or Unexplained Chronic Cough

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Refractory or Unexplained Chronic Cough
Intervention / Treatment

-

Contacts and Locations

Foley

G & L Research, LLC, Foley, Alabama, United States, 36535

Tempe

AMR Phoenix, Tempe, Arizona, United States, 85281

Little Rock

Little Rock Allergy & Asthma, P.A. Clinical Research Center, Little Rock, Arkansas, United States, 72205

Laguna Niguel

Allergy and Asthma Associates of Southern California dba Southern California Research, Laguna Niguel, California, United States, 92677

Newport Beach

NewportNativeMD,Inc, Newport Beach, California, United States, 92663

Redding

Paradigm Clinical Research Centers, LLC, Redding, California, United States, 96001

San Jose

Allergy & Asthma Associates of Santa Clara Valley, San Jose, California, United States, 95117

San Jose

California Allergy & Asthma Medical Group Inc., San Jose, California, United States, 95117

Walnut Creek

Allergy and Asthma Clinical Research Inc, Walnut Creek, California, United States, 94598

Clearwater

Innovative Research of West Florida, Inc., Clearwater, Florida, United States, 33756

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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 (not including resolved childhood asthma), or other pulmonary disease.
  • * Respiratory tract infection within 4 weeks of Screening.
  • * Any female who is pregnant or lactating or wishing to become pregnant.
  • * Donation of \> 1 Unit (450 milliliter or more) of blood within 90 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, 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).

Ages Eligible for Study

18 Years to 80 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Nocion Therapeutics,

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

Study Record Dates

2025-11-10