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.



Germany