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

What is this study about?

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.

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.

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.

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.

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.

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.

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 Study?

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 Study?

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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Alergo Med Osrodek Badan Klinicznych Sp. z o.o.	Tarnow	Poland
Pneumologisches Forschungsinstitut Hohegeest GbR	Geesthacht	Germany
Katholieke Universiteit te Leuven	Leuven	Belgium

Other Sites

Site Name	City	Country
Algemeen Ziekenhuis Delta	Roeselare	Belgium
Zentrum Fuer Ambulante Pneumologische Forschung Marburg GbR	Marburg	Germany
Pneumo Studien Darmstadt GmbH	Darmstadt	Germany
Pneumocare	Namur	Belgium
Velocity Clinical Research Luebeck GmbH	Luebeck	Germany
Medaimun GmbH	Frankfurt	Germany
Pratia S.A.	Skorzewo	Poland
K2J2 Centrum Medyczne	Wołomin	Poland
Pneumologicum im Suedstadtforum Dr. Alexander Schulz Dr. Martin Hoffmann Dr. Henning Geldmacher PD Dr. Hendrik Suhling Fachaerzte fuer Innere Medizin Pneumologie Partnerschaftsgesellschaft	Hanover	Germany
Pneumologische Praxis München-Pasing	Munich	Germany
Pneumologisches Studienzentrum MVZ die Lungenärzte	Berlin	Germany
Prywatna Praktyka Lekarska Gabinet Pediatryczno-Alergologiczny Anna Płoszczuk	Bialystok	Poland
Okvswbghztij Ckbmutt Miokmlql Agnm Ogjaa Cclnee Kiauokgte Ctcemd sqwb	Ostrowiec Swietokrzyski	Poland
Ekuyjdc	Mechelen	Belgium
Gzvqsqx Pvyrbxbvftlv i Dwyhjcbtxbi Cuhntf Agtpdcldjurv Dgfxwf Mirzp Macauoy	Szczecin	Poland
Pthxkpbc Ghhdtpp Ihgxnrlyjdhggysncaifwlochblhq Zuzlb Securpeceg	Bialystok	Poland
Pfhanualwspwt Hczch	Halle (Saale)	Germany

Trial status

Country	Status	Recruitment Start
Belgium	Not recruiting	31.12.2024
Germany	Not recruiting	31.12.2024
Poland	Not recruiting	31.12.2024

Trial locations

Investigated drugs:

Taplucainium Chloride

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.

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.

Trial ID:

2024-515026-86-00

Protocol code:

NOC110-C-202

Trial Phase:

Therapeutic exploratory (Phase II)

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?