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

Verified siteInvestigational

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a condition known as Refractory or Unexplained Chronic Cough, which is a persistent cough that lasts for a long time without a clear cause or does not respond to usual treatments. The study is testing a new treatment called Taplucainium Inhalation Powder, also known by its code name NOC-110. This medication is taken by inhaling a powder through a device called a Monodose Dry Powder Inhaler. The purpose of the study is to evaluate how effective and safe this treatment is for adults who have this type of chronic cough.

Participants in the study will be randomly assigned to receive either the Taplucainium Inhalation Powder or a placebo, which looks like the treatment but does not contain the active ingredient. The study will last for 28 days, during which participants will take the treatment once daily. The study will test three different dose levels of the medication: 1 mg, 3 mg, and 6 mg. Researchers will monitor how often participants cough over a 24-hour period to see if the treatment reduces cough frequency.

Throughout the study, participants will be asked to report any side effects they experience. The study will also assess changes in how severe the cough feels and the urge to cough, using simple scales and questionnaires. The goal is to determine if Taplucainium Inhalation Powder can help reduce the symptoms of chronic cough and improve the quality of life for those affected by this condition.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, you will be asked to provide informed consent. This means you agree to participate after understanding the study's purpose and procedures.
You will be required to confirm that you have had a chronic cough for at least 12 months and meet other eligibility criteria.
Step 2
Initial assessment
An initial assessment will be conducted to establish a baseline for your cough frequency and severity. This may involve using a device called VitaloJAK to count your coughs over 24 hours.
You will also complete questionnaires to assess your cough severity and its impact on your life.
Step 3
Medication administration
You will be randomly assigned to receive either the Taplucainium Inhalation Powder or a placebo. The placebo is a substance with no active medication.
The medication or placebo will be administered once daily for 28 days. The dose levels of Taplucainium are 1 mg, 3 mg, or 6 mg, delivered through inhalation.
Step 4
Ongoing monitoring
Throughout the 28-day period, your cough frequency will be monitored using the VitaloJAK device.
You will be asked to complete additional questionnaires to track any changes in your cough and its impact on your daily life.
Step 5
Final assessment
At the end of the 28 days, a final assessment will be conducted to evaluate changes in your cough frequency and severity.
You will also provide feedback on your overall impression of any improvements in your condition.
Step 6
Safety evaluation
Throughout the study, any adverse events or side effects will be recorded to ensure your safety.
A final safety evaluation will be conducted at the end of the study to assess any potential side effects from the medication.

Who can join the trial?

4 criteria

Have a refractory or unexplained chronic cough for at least 12 months. This means having a cough that does not go away and the cause is not known.
Women who can have children must agree to use specific birth control methods during the study.
Men who have not had a vasectomy must agree to use specific birth control methods during the study. A vasectomy is a medical procedure that makes a man unable to father children.
Must be able to provide informed consent. This means you understand the study and agree to participate.

Who cannot join the trial?

3 criteria

Patients who have a **chronic cough** that is not **refractory** or **unexplained** cannot participate. A **chronic cough** is a cough that lasts a long time. **Refractory** means it does not get better with treatment, and **unexplained** means the cause is not known.
Patients who are not within the specified age range for the study cannot participate. The study is for adults only.
Patients who are part of a **vulnerable population** cannot participate. A **vulnerable population** includes groups of people who may need special protection, like children or pregnant women.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Algemeen Ziekenhuis Delta
Verified
Roeselare, Belgium
Katholieke Universiteit te Leuven
Responsive
Leuven, Belgium
Pneumocare
Responsive
Namur, Belgium

Trial locations

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Investigated drugs

Taplucainium Inhalation Powder (NOC-110) is a medication being tested to help people who have a chronic cough that doesn't go away or can't be explained. This medication is taken by inhaling it, which means you breathe it in so it can work directly in your lungs. The goal of using this medication is to see if it can reduce how often you cough over a day. The study is looking at how safe and effective this medication is when used once a day for 28 days. By participating in this trial, researchers hope to find out if this medication can help people with persistent coughs feel better and cough less often.

Taplucainium Chloride

What is already known about the treatment

Taplucainium Inhalation Powder (NOC-110) – This medication is administered as an inhalation powder, meaning it is breathed in through the mouth using a special inhaler device. It is currently being studied in clinical trials and is not yet widely available in medical practice. The main use of Taplucainium is to help reduce the frequency of chronic coughs that do not respond to other treatments or have no clear cause. It works by targeting specific pathways in the body that are involved in the cough reflex, helping to calm the urge to cough. Taplucainium is classified as a respiratory medication, focusing on conditions affecting the lungs and airways.

Investigated diseases

Refractory or Unexplained Chronic Cough – This condition is characterized by a persistent cough that lasts for more than eight weeks and does not respond to standard treatments. The cough is often dry and can occur at any time of the day or night. It may be triggered by various factors, including environmental irritants, but the exact cause is often unknown. The cough can be disruptive to daily life, affecting sleep and social interactions. Over time, the persistent coughing can lead to physical discomfort, such as sore throat or chest pain. The condition is diagnosed when other potential causes of chronic cough, such as asthma or gastroesophageal reflux disease, have been ruled out.