Taplucainium Inhalation Powder (NOC-110) in Adults withRefractory or Unexplained Chronic Cough
Research type
Research Study
Full 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
IRAS ID
1010343
Contact name
Joan Shaw
Contact email
Sponsor organisation
Nocion Therapeutics, Inc.
Clinicaltrials.gov Identifier
Research summary
The purpose of this clinical research study is to look at whether the investigational study drug, taplucainium, works and how safe it is in adults with refractory or unexplained chronic cough (rCC). Refractory means that treatments have not made it better; chronic means long term.
Taplucainium is a dry powder that has been placed into a capsule. Participants will take the capsule using an inhaler, which will release the powder allowing the participants to breathe the powder in. Taplucainium is designed to block the signals sent from cough receptors in the throat and airways. These signals tell the brain to cause coughing.
In this study, the study drug, taplucainium, will be compared with a placebo. A placebo looks like the study drug but does not contain any actual medicine. During the study, participants will be randomly assigned to receive the study drug or placebo.
The total duration of the study for each participant will be approximately 13 weeks, including a Screening period (up to 4 weeks); a Study treatment period (up to 7 weeks) and a Follow-up period (about 2 weeks).
Only people who are aged 18 to 80 years; have had a persistent cough for more than 1 year and have seen a doctor and received prescribed or over-the-counter medicines but their cough as not gotten better, or has only improved a little can take part.
This study is sponsored by Nocion Therapeutics, Inc. Approximately 325 participants will take part in the study across all study centres in the United States, Canada, and Europe, including several sites in the United Kingdom.
REC name
Wales REC 5
REC reference
24/WA/0279
Date of REC Opinion
12 Nov 2024
REC opinion
Further Information Favourable Opinion