Study to Assess the Efficacy, Safety, and Tolerability of NOC-110 in Adults With Refractory or Unexplained Chronic Cough
NCT Number: NCT06504446
Acronym: ASPIRE
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Refractory or Unexplained Chronic Cough
Interventions: DRUG: NOC-110|OTHER: Placebo
Sponsor: Nocion Therapeutics
Collaborators: Iqvia Pty Ltd
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 325
Study Design: Allocation: RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-08-08
Completion Date: 2025-11-10

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.

Primary Outcome Measures: Change in 24-hour Coughs per hour from Baseline, 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., Baseline to End of Treatment
Secondary Outcome Measures: Change in Awake coughs per hour from Baseline, 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., Baseline to End of Treatment|Change in the Cough Severity Visual Analog Scale from Baseline, 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.", Baseline to End of Treatment|Change in the Urge to Cough Visual Analog Scale from Baseline, 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.", Baseline to End of Treatment|Change in the Leicester Cough Questionnaire from Baseline, 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., Baseline to End of Treatment|Patient Global Impressions of Improvement score, 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., End of Treatment|Incidence and severity of adverse events and serious adverse events, Baseline to End of Treatment