Study to Assess the Efficacy, Safety, and Tolerability of NOC-110 in Adults with Refractory or Unexplained Chronic Cough
- Conditions
- Refractory or Unexplained Chronic Cough
- Interventions
- Other: Placebo
- Registration Number
- NCT06504446
- Lead Sponsor
- Nocion Therapeutics
- Brief 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.
- Detailed Description
Approximately 325 participants will take part in the study. It is anticipated that up to 600 participants will be screened. Participation will be approximately 13 weeks.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 325
- 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, 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 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).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description NOC-110 6mg NOC-110 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. Placebo 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. NOC-110 1mg NOC-110 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. NOC-110 3mg NOC-110 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.
- Primary Outcome Measures
Name Time Method Change in 24-hour Coughs per hour from Baseline 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.
- Secondary Outcome Measures
Name Time Method Change in the Cough Severity Visual Analog Scale from Baseline 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."
Change in Awake coughs per hour from Baseline 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.
Change in the Leicester Cough Questionnaire from Baseline 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.
Change in the Urge to Cough Visual Analog Scale from Baseline 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."
Patient Global Impressions of Improvement score 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.
Incidence and severity of adverse events and serious adverse events Baseline to End of Treatment
Trial Locations
- Locations (81)
G & L Research, LLC
🇺🇸Foley, Alabama, United States
AMR Phoenix
🇺🇸Tempe, Arizona, United States
Little Rock Allergy & Asthma, P.A. Clinical Research Center
🇺🇸Little Rock, Arkansas, United States
Allergy and Asthma Associates of Southern California dba Southern California Research
🇺🇸Laguna Niguel, California, United States
NewportNativeMD,Inc
🇺🇸Newport Beach, California, United States
Center for Clinical Trials, LLC
🇺🇸Paramount, California, United States
Paradigm Clinical Research Centers, LLC
🇺🇸Redding, California, United States
Allergy & Asthma Associates of Santa Clara Valley
🇺🇸San Jose, California, United States
California Allergy & Asthma Medical Group Inc.
🇺🇸San Jose, California, United States
Allergy and Asthma Clinical Research Inc
🇺🇸Walnut Creek, California, United States
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