In short
This article discusses a Phase 2b clinical trial investigating the use of Taplucainium Chloride Inhalation Powder (NOC-110) in adults with refractory or unexplained chronic cough. The study aims to assess the effectiveness, safety, and tolerability of this new treatment option for a condition that can significantly impact patients' quality of life. The trial will evaluate different doses of the medication over a 28-day period, comparing its effects to a placebo.
At a glance
- Study Type
- Phase 2b, Randomized, Double-Blind, Placebo-Controlled
- Medication
- Taplucainium Inhalation Powder (NOC-110)
- Condition
- Refractory or Unexplained Chronic Cough
- Duration
- 28 days
- Dosage
- 1 mg, 3 mg, or 6 mg once daily
- Primary Endpoint
- Change in 24-hour Coughs per hour
- Key Secondary Endpoints
- Awake coughs per hour, Quality of Life measures, Safety and tolerability
- Administration
- Inhalation using Monodose Dry Powder Inhaler RS01
- Key Inclusion Criteria
- Chronic cough for ≥12 months, Able to provide Informed Consent
- Key Exclusion Criteria
- Previous exposure to taplucainium, Current opiate use, Concurrent malignancy, BMI ≥40 kg/m2
What is Taplucainium Chloride?
Taplucainium Chloride is an investigational medication being developed to treat chronic cough conditions. It is also known by several other names, including NOC-100 chloride and NTX-1175 chloride. The drug is currently being studied in a clinical trial to assess its effectiveness and safety for people with persistent cough problems.
Medical Conditions Targeted
Taplucainium Chloride is specifically being studied for two types of chronic cough:
- Refractory chronic cough: This is a cough that persists despite treatment of any identified underlying conditions.
- Unexplained chronic cough: This is a long-lasting cough with no clear cause, even after medical evaluations.
Both of these conditions involve coughing that has lasted for 12 months or longer. Chronic cough can significantly impact a person's quality of life, causing distress and interfering with daily activities.
How Taplucainium Chloride Works
While the exact mechanism of action is not detailed in the provided information, Taplucainium Chloride is being developed as an inhalation powder. This suggests that it may work directly on the airways to reduce cough sensitivity or frequency. Inhalation medications often target the lungs and airways more directly than oral medications.
Current Clinical Trial
Taplucainium Chloride is currently being studied in a Phase 2b clinical trial. This trial is:
- Randomized: Participants are randomly assigned to different groups.
- Double-blind: Neither the participants nor the researchers know who is receiving the actual drug or a placebo.
- Placebo-controlled: Some participants will receive an inactive substance for comparison.
The main goal of this study is to evaluate how effective Taplucainium Chloride is in reducing cough frequency over a 24-hour period after 28 days of treatment.
Dosage and Administration
In the current trial, Taplucainium Chloride is being tested as an inhalation powder. The study is evaluating three different dose levels:
- 1 mg once daily
- 3 mg once daily
- 6 mg once daily
The medication is administered using a special inhaler device called the Monodose Dry Powder Inhaler RS01. This device uses capsules containing the medication, which are inhaled by the patient.
Who Can Participate in the Trial?
The trial has specific criteria for who can participate. Some key points include:
- Adults with refractory or unexplained chronic cough for 12 months or longer
- Participants must not have certain health conditions, such as COPD, bronchiectasis, or active respiratory infections
- Non-smokers or those who quit smoking more than 6 months ago
- No current use of opioid medications
- No participation in other cough-related studies within the past 60 days
There are additional criteria that a healthcare provider would review with potential participants.
Potential Benefits
While the effectiveness of Taplucainium Chloride is still being studied, the researchers hope to see improvements in several areas:
- Reduced cough frequency over 24 hours
- Decreased cough severity
- Reduced urge to cough
- Improved quality of life for people with chronic cough
These potential benefits are being measured using specialized cough monitoring devices and questionnaires about cough symptoms and overall well-being.
Safety Considerations
As with any investigational medication, safety is a crucial aspect of the study. The researchers are carefully monitoring for any side effects or adverse events throughout the trial. Some important safety considerations include:
- The study excludes people with certain health conditions to minimize potential risks.
- Participants are closely monitored throughout the 28-day treatment period.
- The trial uses different dose levels to help determine the safest and most effective dose.
- Women who are pregnant or breastfeeding are not eligible to participate due to unknown risks.
It's important to note that as an investigational drug, the full safety profile of Taplucainium Chloride is not yet known. The current clinical trial aims to gather more information about both its effectiveness and potential side effects.