Inhalation therapy in adult bronchiectasis patients with new asymptomatic Pseudomonas aeruginosa infection– an open-label, proof of concept - randomized controlled trial

Ki vehet részt

• Age ≥ 18 years at screening
• Bronchiectasis verified by chest CT scan
• New positive sputum culture for PA (not older than 12 weeks at screening)
• No recent onset of new respiratory symptoms or worsening of pre-existing respiratory symptoms (e.g. cough, sputum amount, sputum colour, sputum viscosity, haemoptysis, decreased exercise capacity, malaise, fatigue etc.) over the last 2 months before new positive PA sputum culture, as per investigator judgement
• Written informed consent
• Negative serum/urine pregnancy test in women of childbearing potential (WOCBP) at screening
• WOCBP must agree to maintain a highly effective method of contraception during study treatment and at least 4 weeks thereafter
• Male subjects have to use condom during treatment and until the end of relevant systemic exposure in the male subject, plus a further 90-day period and non-pregnant WOCBP partner have to use any contraception method additionally

Ki nem vehet részt

• Known prior infection with PA in the past 5 years before the new positive PA culture
• Treatment with pseudomonas-active antibiotics in the period between new PA positive sputum culture and baseline visit
• Any treatment with inhaled antibiotics or long-term pseudomonas-active treatment (≥3 months) in the past 5 years before screening
• Known intolerance to ColiFin® in prior medical history
• strongly impaired renal function, GFR ≤ 30 ml/min
• Hypersensitivity/Known intolerance to Colistimethate sodium, Colistin, polymyxin B or to other polymyxins
• Bronchiectasis due to cystic fibrosis
• Pregnant women
• Breast feeding women
• Participation in any other interventional clinical trial
• Planned pseudomonas-active antibiotic treatment during the time of study participation
• Known diagnosis of myasthenia gravis or porphyria
• ppFEV1 < 30% (post-bronchodilator)