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Study on the Effectiveness and Safety of Camlipixant for Adults with Refractory or Unexplained Chronic Cough

Fast replyInvestigational

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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 Chronic Cough, which includes cases of Unexplained Chronic Cough. This condition is characterized by a persistent cough that does not respond to standard treatments. The trial will evaluate a new treatment called BLU-5937, which contains the active substance Camlipixant. Participants in the study will receive either BLU-5937 or a placebo, which is a substance with no active medication, to compare the effects on cough frequency and safety.

The purpose of the study is to assess how effective BLU-5937 is in reducing the frequency of coughing over a 24-hour period in adults with this chronic cough condition. The study will also monitor the safety of BLU-5937 over a period of 24 weeks. Participants will be randomly assigned to receive either the medication or a placebo, and neither the participants nor the researchers will know who is receiving which treatment during the study period. This is known as a double-blind study, which helps ensure unbiased results.

The study will last for 24 weeks, with an additional open-label extension phase where all participants may receive BLU-5937. During the study, participants will have regular check-ups to monitor their health and any changes in their cough frequency. The study aims to provide valuable information on the potential benefits and safety of BLU-5937 for people suffering from refractory or unexplained chronic cough.

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, participants are required to provide informed consent, confirming their understanding of the study's purpose and procedures.
Eligibility is confirmed based on criteria such as age (18-80 years), diagnosis of refractory chronic cough for at least one year, and specific cough frequency requirements.
Step 2
Randomization and initial assessment
Participants are randomly assigned to receive either the study medication, BLU-5937, or a placebo. This process is double-blind, meaning neither the participants nor the researchers know who receives the medication or placebo.
Initial assessments include baseline measurements of cough frequency and other health indicators.
Step 3
Medication administration
Participants take the assigned tablets orally. The tablets are oval, biconvex, and white to off-white in color.
The study medication, BLU-5937, is administered over a 24-week period. The exact dosage and frequency are determined by the study protocol.
Step 4
Monitoring and assessments
Throughout the 24-week period, participants undergo regular monitoring to assess cough frequency and any changes in health status.
Assessments include measuring 24-hour cough frequency, vital signs, and laboratory values. Participants may also complete questionnaires about their symptoms and quality of life.
Step 5
Completion of the double-blind phase
At the end of the 24-week period, participants complete the double-blind phase of the study.
Final assessments are conducted to evaluate the primary and secondary endpoints, such as changes in cough frequency and any adverse effects experienced.
Step 6
Open-label extension
Participants may have the option to continue in an open-label extension phase, where all participants receive BLU-5937.
This phase allows for further evaluation of the medication's long-term safety and effectiveness.

Who can join the trial?

5 criteria

Must be between 18 and 80 years old.
Must be able to understand and agree to the written informed consent, which is a document explaining the study and what participation involves.
Must have been diagnosed with Refractory Chronic Cough (a persistent cough that doesn't respond to treatment) or Unexplained Chronic Cough (a persistent cough with no known cause) for at least 1 year before the screening.
Must meet the specific criteria for how often they cough.
If female, must not be pregnant or breastfeeding. She must either not be able to become pregnant or agree to use birth control as advised.

Who cannot join the trial?

8 criteria

Patients who have a cough caused by a known medical condition other than **Refractory Chronic Cough** or **Unexplained Chronic Cough**. This means if your cough is due to another illness, you cannot participate.
Patients who are currently taking medications that might affect the study results. This means if you are on certain drugs that could change how the study works, you cannot join.
Patients with a history of significant lung diseases, such as **asthma** or **chronic obstructive pulmonary disease (COPD)**. These are conditions that affect your breathing and lungs.
Patients who have had recent surgery or are planning to have surgery during the study period. Surgery can affect your health and the study results.
Patients who are pregnant or breastfeeding. This is to ensure the safety of both the mother and the baby.
Patients who have participated in another clinical trial within the last 30 days. This is to avoid any interference with the current study.
Patients with a history of drug or alcohol abuse. This is to ensure that participants are in a stable condition to take part in the study.
Patients with any other medical condition that the study doctors believe would make it unsafe for them to participate. This means if there is any other health issue that could be risky, you cannot join.

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Verified sites

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

Verified
Fakultni Nemocnice Brno
Brno, Czechia
Verified
Goethe University Frankfurt
Frankfurt, Germany
Responsive
Thoraxklinik Heidelberg gGmbH
Heidelberg, Germany

Trial locations

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Investigated drugs

BLU-5937 is a medication being studied for its potential to reduce the frequency of coughing in adults who have a persistent cough that does not have a clear cause. This trial aims to see how effective and safe BLU-5937 is over a period of 24 weeks. Participants in the study will receive this medication to determine if it can help manage their chronic cough symptoms.

Camlipixant

What is already known about the treatment

BLU-5937 – This medication is administered orally and is currently being studied in clinical trials for its effectiveness in treating refractory chronic cough, including unexplained chronic cough. It is in the phase 3 stage of clinical trials, which means it is being tested for efficacy and safety in a larger group of participants. The main therapeutic indication for BLU-5937 is to reduce the frequency of chronic coughs that do not respond to standard treatments. At the molecular level, BLU-5937 works by blocking specific receptors in the body that are involved in the cough reflex, potentially reducing the urge to cough. It is classified pharmacologically as a selective P2X3 receptor antagonist.

Investigated diseases

Refractory Chronic Cough – This condition is characterized by a persistent cough that does not respond to standard treatments. It often lasts for more than eight weeks and can significantly impact a person's quality of life. The cough may be dry or produce mucus and can occur at any time of the day or night. The exact cause of refractory chronic cough is often unknown, making it challenging to manage. It may be associated with other conditions such as asthma, gastroesophageal reflux disease, or postnasal drip. The cough can be triggered by irritants like smoke, dust, or strong odors.