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
Trial Snapshot
- Phase
- Phase 2
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 455
- Locations
- 202
- Primary Endpoint
- Change in 24-hour Coughs per hour from Baseline
Study Overview
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 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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Sequential
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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/m
- •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).
Arms & Interventions
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.
Intervention: Placebo (Other)
NOC-110 1mg
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.
Intervention: NOC-110 (Drug)
NOC-110 3mg
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.
Intervention: NOC-110 (Drug)
NOC-110 6mg
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.
Intervention: NOC-110 (Drug)
Outcomes
Primary Outcomes
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
- Change in the Cough Severity Visual Analog Scale from Baseline(Baseline to End of Treatment)
- Change in Awake coughs per hour from Baseline(Baseline to End of Treatment)
- Change in the Leicester Cough Questionnaire from Baseline(Baseline to End of Treatment)
- Change in the Urge to Cough Visual Analog Scale from Baseline(Baseline to End of Treatment)
- Patient Global Impressions of Improvement score(End of Treatment)
- Incidence and severity of adverse events and serious adverse events(Baseline to End of Treatment)