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NCT Number: NCT06504446

Study to Assess the Efficacy, Safety, and Tolerability of 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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Refractory or Unexplained Chronic Cough

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

UZ Leuven, Leuven, Belgium

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

NOC-110

Drug

Inhalation powder

Other names: taplucainium

Placebo

Other

Inhalation powder

Primary outcomes

  1. Change in 24-hour Coughs per hour from Baseline

    Time frame: 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 outcomes

  1. Change in Awake coughs per hour from Baseline

    Time frame: 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.

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

    Time frame: 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."

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

    Time frame: 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."

  4. Change in the Leicester Cough Questionnaire from Baseline

    Time frame: 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.

  5. Patient Global Impressions of Improvement score

    Time frame: 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.

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

    Time frame: Baseline to End of Treatment

Other outcomes

  1. Change in 24-hour and awake coughs per hour from Baseline with the Hyfe CoughMonitor System

    Time frame: Baseline to End of Treatment

    Change in 24-hour and awake coughs per hour from Baseline will be based on Hyfe CoughMonitor System cough counts. The Hyfe CoughMonitor Suite is an end-to-end system for continuous, objective cough monitoring in clinical trials. It has been rigorously validated and has been submitted (de novo) in 2023 to the FDA. The system consists of a mic-equipped wrist-worn watch (current recommended model is Shenzhen DO Intelligent Technology Co. ID206) running the Hyfe Cough-Monitor smartwatch app.

Sponsors and collaborators

Lead sponsor

Nocion Therapeutics

Industry

Collaborators

  • IQVIA Pty Ltd

Registry information

Official study 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

Acronym: ASPIRE

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jul 16, 2024
Registry last updated
Jun 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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