Study to Assess the Efficacy, Safety, and Tolerability of NOC-110 in Adults With Refractory or Unexplained Chronic Cough

Conditions

• Refractory or Unexplained Chronic Cough

Eligibility Criteria

Sex

ALL

Age

18 Years - 80 Years

Healthy Volunteers

Not accepted

Interventions

• NOC-110 — DRUG
  Inhalation powder
• Placebo — OTHER
  Inhalation powder

Study Details

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.

Key Dates

First listed

Jul 16, 2024

Start date

Sep 24, 2024

Status verified

Jun 2026

Primary completion

Jun 15, 2026

Completion

Jun 29, 2026

Study Design

Enrollment

455 participants (estimated)

Allocation

RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Experimental: 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.
• Experimental: 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.
• Experimental: 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.
• Placebo Comparator: 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.

Primary Outcome Measure

Change in 24-hour Coughs per hour from Baseline [ Time Frame: Baseline to End of Treatment ]

Locations (68)

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