A Phase 3 Study Design of Pulmaquin® in Non-Cystic Fibrosis Bronchiectasis (NCFBE) Patients Chronically Colonized with Pseudomonas aeruginosa (PA)
A O'Donnell, D Bilton, D Serisier, A Wanner, J Froehlich, P Bruinenberg, I Gonda · Pneumologie · 2016 · Heft 10
Bibliografische Angaben
Zusammenfassung
Introduction: Bronchiectasis is a neglected disease in respiratory medicine. In adult NCFBE patients, PA infections are associated with an increased risk of death, hospital admissions and exacerbations. There is no approved treatment to prevent pulmonary exacerbations (PE) in bronchiectasis. Methods: Pulmaquin, a once-a-day inhaled dual-release formulation composed of both liposome encapsulated and unencapsulated ciprofloxacin, is being evaluated in two Phase 3 trials in patients with CT-scan documented NCFBE who have chronic lung infections with PA. The subjects must have had at least 2 PEs in the 12 months pri…