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Study on Inhaled Colistimethate Sodium for Adults with Bronchiectasis and New Asymptomatic Pseudomonas Aeruginosa Infection

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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 lung condition called bronchiectasis, which involves damage to the airways, leading to symptoms like persistent cough and mucus production. The study is specifically looking at patients with a new, symptom-free infection caused by a bacteria known as Pseudomonas aeruginosa. The treatment being tested is called ColiFin®, which is a medication used in the form of a nebulizer solution. This means the medication is inhaled as a mist to reach the lungs directly. The active ingredient in ColiFin® is colistimethate sodium, which belongs to a group of medicines known as antibacterial agents.

The purpose of the study is to evaluate the effect of ColiFin® therapy compared to standard care in achieving negative sputum or airway cultures for Pseudomonas aeruginosa 28 weeks after starting the treatment. Participants in the study will be randomly assigned to receive either the ColiFin® treatment or standard care. The study will monitor the participants over a period of 28 weeks to observe changes in their condition, including the presence of the bacteria in their sputum, the occurrence of lung flare-ups, and any changes in their quality of life and respiratory symptoms.

Throughout the study, researchers will collect data on various aspects, such as the rate of lung exacerbations, which are episodes where symptoms suddenly worsen, and any changes in the participants' ability to fight off the bacteria. The study aims to provide insights into whether ColiFin® can effectively help manage bronchiectasis in patients with this specific bacterial infection.

The research process

The trial runs in 5 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, eligibility is confirmed based on specific criteria such as age, medical condition, and recent health status.
Written informed consent is required to participate in the study.
Step 2
Treatment initiation
The treatment involves the use of ColiFin®, a medication administered through inhalation.
The medication is a nebuliser solution containing colistimethate sodium.
Step 3
Treatment schedule
The treatment is administered as per the study protocol, with specific dosages and frequency determined by the study guidelines.
The primary goal is to achieve negative sputum/airway cultures for Pseudomonas aeruginosa 28 weeks after starting the treatment.
Step 4
Monitoring and assessments
Regular monitoring of health status and response to treatment is conducted throughout the study period.
Assessments include changes in respiratory symptoms, quality of life, and any pulmonary exacerbations.
Step 5
End of treatment evaluation
At the end of the treatment period, a final evaluation is conducted to assess the effectiveness of the therapy.
The study aims to measure the proportion of participants achieving negative sputum cultures and improvements in quality of life.

Who can join the trial?

8 criteria

Must be **18 years or older** at the time of screening.
Must have **bronchiectasis**, which is a lung condition, confirmed by a **chest CT scan** (a special type of X-ray).
Must have a **new positive sputum culture** for PA (a type of bacteria) that is not older than 12 weeks at the time of screening.
Must not have any new or worsening **respiratory symptoms** (like cough, changes in sputum, or difficulty breathing) in the last 2 months before the new positive PA sputum culture, as judged by the study doctor.
Must provide **written informed consent**, which means agreeing to participate in the study after understanding all the details.
Women who can have children must have a **negative pregnancy test** at screening.
Women who can have children must agree to use a **highly effective method of birth control** during the study treatment and for at least 4 weeks after.
Male participants must use a **condom** during treatment and for a period after, and if their partner can have children, she must also use a birth control method.

Who cannot join the trial?

4 criteria

Patients who are not diagnosed with Bronchiectasis. This is a condition where the airways in the lungs become widened and can lead to infections.
Patients who are not within the specified age range for the study.
Patients who are not part of the specific clinical trial group being studied.
Patients who are part of a vulnerable population, which means they might need special protection or care.

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Verified sites

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

Verified
Charite Universitaetsmedizin Berlin KöR
Berlin, Germany
Responsive
Ludwig Maximilian University Of Munich
Munich, Germany
Responsive
Ruhrlandklinik Westdeutsches Lungenzentrum Am Universitaetsklinikum Essen gGmbH
Essen, Germany

Trial locations

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Investigated drugs

ColiFin® is an inhaled medication used in this trial to treat adult patients with bronchiectasis who have a new asymptomatic infection with Pseudomonas aeruginosa. The goal of using this medication is to see if it can help clear the infection from the sputum or airways of the patients.

Colistimethate Sodium

What is already known about the treatment

ColiFin – ColiFin is administered as an inhalation therapy, specifically designed for patients with bronchiectasis who have a new asymptomatic infection with Pseudomonas aeruginosa. Currently, it is being evaluated in clinical trials to determine its effectiveness in achieving sputum or airway culture negativity for Pseudomonas aeruginosa over a 28-week period. The main therapeutic indication for ColiFin is the treatment of lung infections caused by Pseudomonas aeruginosa in patients with bronchiectasis. At the molecular level, ColiFin works by disrupting the bacterial cell membrane, leading to the death of the bacteria. It is classified pharmacologically as an antibiotic.

Investigated diseases

Bronchiectasis – This is a chronic condition where the walls of the bronchi, the air passages in the lungs, become permanently widened. This widening leads to a build-up of excess mucus, which can make the lungs more vulnerable to infection. Over time, repeated infections can cause further damage to the airways, leading to a cycle of infection and inflammation. People with bronchiectasis often experience a persistent cough, production of sputum, and frequent lung infections. The condition can vary in severity, with some individuals experiencing mild symptoms and others having more severe respiratory issues. Regular monitoring and management are essential to help control symptoms and prevent complications.