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Taplucainium Chloride

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.

Table of Contents

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[1]. 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[1]:

  • 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[1]. 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[1]. 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[1]. 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[1].

Dosage and Administration

In the current trial, Taplucainium Chloride is being tested as an inhalation powder[1]. The study is evaluating three different dose levels:

  1. 1 mg once daily
  2. 3 mg once daily
  3. 6 mg once daily

The medication is administered using a special inhaler device called the Monodose Dry Powder Inhaler RS01[1]. 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[1]:

  • 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[1]:

  • 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[1]. 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.

Aspect Details
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

FAQ

  • What is Taplucainium Chloride Inhalation Powder? Taplucainium Chloride Inhalation Powder, also known as NOC-110, is an investigational drug being studied for the treatment of refractory or unexplained chronic cough. It is administered through inhalation using a special device called a dry powder inhaler.
  • Who is eligible to participate in this clinical trial? The trial is open to adults who have had refractory or unexplained chronic cough for at least 12 months. Participants must be able to provide informed consent and follow contraceptive guidelines if applicable. However, there are several exclusion criteria, such as certain medical conditions or recent participation in other cough-related studies.
  • What are the main objectives of this clinical trial? The main objective is to evaluate the effects of Taplucainium Inhalation Powder on 24-hour cough frequency compared to a placebo. Secondary objectives include assessing its impact on awake-cough frequency, quality of life measures, and overall safety and tolerability.
  • How long does the treatment last in this trial? The treatment period in this clinical trial lasts for 28 days. Participants will receive either Taplucainium Inhalation Powder at one of three dose levels (1 mg, 3 mg, or 6 mg) or a placebo once daily during this time.
  • How will the effectiveness of the treatment be measured? The effectiveness will be primarily measured by the change in 24-hour coughs per hour from the beginning to the end of the treatment period. This will be recorded using a special device called VitaloJAK®. Other measures include changes in awake coughs per hour, cough severity, urge to cough, and quality of life questionnaires.

Ongoing Clinical Trials on Taplucainium Chloride

  • Study on the Effectiveness and Safety of Taplucainium Inhalation Powder (NOC-110) for Adults with Refractory or Unexplained Chronic Cough

    Not recruiting

    1
    Investigated drugs:
    Belgium Germany Poland

Glossary

  • Refractory Chronic Cough: A persistent cough that doesn't respond to standard treatments and lasts for an extended period, typically more than 8 weeks.
  • Unexplained Chronic Cough: A long-lasting cough (typically more than 8 weeks) for which no clear cause can be identified despite medical investigations.
  • Phase 2b Trial: A stage of clinical research that aims to determine the effectiveness and optimal dosage of a new drug, typically involving a larger group of patients than earlier phases.
  • Placebo: An inactive substance that looks like the drug being tested but has no medical effect, used as a control in clinical trials to determine the true impact of the investigational treatment.
  • VitaloJAK®: A specialized device used to objectively measure and count coughs in clinical research settings.
  • Dry Powder Inhaler: A device used to deliver medication directly to the lungs in the form of a fine powder that is inhaled.
  • Cough Severity Visual Analog Scale (CS-VAS): A tool used to measure the intensity of cough as perceived by the patient, typically using a scale from 0 to 100.
  • Leicester Cough Questionnaire (LCQ): A validated questionnaire used to assess the impact of cough on quality of life.
  • Patient Global Impressions of Improvement (PGI-I): A scale used to measure a patient's perception of improvement in their condition after treatment.
  • Adverse Events (AEs): Any unfavorable and unintended sign, symptom, or disease that occurs during a clinical trial, whether or not it is related to the treatment being studied.

References

  1. http://clinicaltrials.eu/trial/study-on-the-effectiveness-and-safety-of-taplucainium-inhalation-powder-noc-110-for-adults-with-refractory-or-unexplained-chronic-cough/