Non-Cystic Fibrosis Bronchiectasis
ATS 2016. A1775 - ORBIT-3 and ORBIT-4: Design of a Phase 3 Program to Investigate Safety and Efficacy of Pulmaquin® in Non-Cystic Fibrosis Bronchiectasis (NCFBE) Patients Chronically Colonized with Pseudomonas Aeruginosa (PA)
A. E. O'Donnell, MD et al.
Results: 1046 subjects were screened in the U.S., Canada, Australia, New Zealand, Israel, South Korea, Taiwan, South Africa, U.K., Germany, France, Spain, Italy, Ireland, Georgia, Serbia, Poland, Romania, Latvia and Peru. Both studies have completed enrollment with a total of 584 subjects randomized and dosed.
Conclusions: The two well-controlled clinical trials ORBIT-3 and -4 will provide a large database of well-defined NCFBE subjects with chronic PA colonization to investigate the effect of Pulmaquin on the prevention of PEs using a rigorous definition of exacerbation.
CARE FACULTY PERSPECTIVE: Non-cystic fibrosis bronchiectasis (NCFBE) imposes a significant burden on affected individuals and the health care system. Prescribed treatment regimens for NCFBE infections and exacerbations are often not evidence-based. Clinical trials in well characterized populations are needed to optimize treatment in individuals with NCFBE. Outcomes of these trials will hopefully be presented soon.]