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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
455
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.
Time frame: Baseline to End of Treatment
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.
Time frame: 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."
Time frame: 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."
Time frame: Baseline to End of Treatment
Change in the Leicester Cough Questionnaire from Baseline
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G & L Research, LLC
Foley, Alabama, United States
RECRUITINGMedical Research of Arizona
Scottsdale, Arizona, United States
RECRUITINGAMR Phoenix
Tempe, Arizona, United States
RECRUITINGLittle Rock Allergy & Asthma, P.A. Clinical Research Center
Little Rock, Arkansas, United States
RECRUITINGSo Cal Clinical Research
Huntington Beach, California, United States
RECRUITINGAllergy and Asthma Associates of Southern California dba Southern California Research
Laguna Niguel, California, United States
RECRUITINGParadigm Clinical Research Centers, LLC - Modesto
Modesto, California, United States
RECRUITINGNewportNativeMD,Inc
Newport Beach, California, United States
RECRUITINGCenter for Clinical Trials, LLC
Paramount, California, United States
RECRUITINGParadigm Clinical Research Centers, LLC
Redding, California, United States
RECRUITING...and 97 more locations
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.
Time frame: 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.
Time frame: End of Treatment
Incidence and severity of adverse events and serious adverse events
Time frame: Baseline to End of Treatment