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
Nocion Therapeutics
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.
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.
Eligibility
- Age range
- 18–80 years
- Sex
- All
- 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 st…
Interventions
- DrugNOC-110
Inhalation powder
- OtherPlacebo
Inhalation powder
Locations (107)
- G & L Research, LLCFoley, Alabama
- Medical Research of ArizonaScottsdale, Arizona
- AMR PhoenixTempe, Arizona
- Little Rock Allergy & Asthma, P.A. Clinical Research CenterLittle Rock, Arkansas
- So Cal Clinical ResearchHuntington Beach, California
- Allergy and Asthma Associates of Southern California dba Southern California ResearchLaguna Niguel, California