Patients with bronchiectasis disease and a chronic infection with the bacterium Pseudomonas aeruginosa in the lungs have more symptoms and a poorer quality of life than patients whose lungs are not infected with this pathogen. If Pseudomonas aeruginosa is detected in the sputum for the first time, antibiotic therapy is therefore often administered. Whether such antibiotic therapy can eliminate (“eradicate”) the pathogen from the lungs has not been sufficiently investigated scientifically. This study therefore examines patients in whom Pseudomonas aeruginosa is detected in the sputum for the first time. Treatment with the inhaled antibiotic colistin in addition to the existing standard therapy will be investigated for 4 weeks. Both groups will then be regularly monitored for 6 months. The aim of the study is to find out whether such a therapy can eliminate Pseudomonas aeruginosa from the lungs or whether there are certain reasons that favor a permanent infection with this germ. The trial is designed to evaluate the efficacy of inhaled ColiFin® in adult bronchiectasis patients with asymptomatic Pseudomonas aeruginosa (PA) infection. Primary endpoint for efficacy assessment is the proportion of patients with ‘successful’ (i.e. three or more subsequent tests for sputum/airway cultures having consistently negative have results) PA eradication 28 weeks after randomization. For evaluation of superiority, the null hypothesis of a success rate being equal or less in the ColiFin® group when compared to the control group will be tested by means of a one tailed chi square test given a onesided significance level of 2.5 %.
