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

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What is this study about?

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.

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.

2 treatment initiation

The treatment involves the use of ColiFin®, a medication administered through inhalation.

The medication is a nebuliser solution containing colistimethate sodium.

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.

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.

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 Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Medizinische Hochschule Hannover Hanover Germany
Augustinerinnen Krankenhaeuser gGmbH Cologne Germany

Other Sites

Site Name City Country Status
Charite Universitaetsmedizin Berlin KöR Berlin Germany
Philipps-Universitaet Marburg Marburg Germany
Robert Bosch Krankenhaus GmbH Stuttgart Germany
Ruhrlandklinik Westdeutsches Lungenzentrum Am Universitaetsklinikum Essen gGmbH Essen Germany
HELIOS Klinikum Emil von Behring GmbH Berlin Germany
SLK-Kliniken Heilbronn GmbH Heilbronn Germany
Universitaetsklinikum Schleswig-Holstein AöR Kiel Germany
Ludwig Maximilian University Of Munich Munich Germany
Waldburg-Zeil Akutkliniken GmbH & Co. KG Wangen Germany
Gcwbhb Utvthhdycj Fksrgcasa Frankfurt Germany
Upqdutprepxkpmuhupbts Dwsqqxwuedv Atg Duesseldorf Germany

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Germany Germany
Recruiting
24.02.2023

Trial locations

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.

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.

Trial ID:
2023-509277-22-00
Protocol code:
KKS-287
Trial Phase:
Therapeutic exploratory (Phase II)

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