Phase III study of Arikace (Insmed) in Cystic Fibrosis patients with Pseudomonas lung infections begins in Europe

A Phase III study of Arikace (liposomal amikacin for inhalation), from Insmed, for Cystic Fibrosis (CF) patients with Pseudomonas aeruginosa (Pa) lung infections has begun in Europe. CLEAR-108 is a randomized trial comparing Arikace 560 mg, delivered once daily via an optimized, investigational eFlow Nebulizer System (PARI Pharma GmbH) with TOBI (inhaled tobramycin solution), a commercially available inhaled antibiotic that is delivered twice daily. The study will be conducted in approximately 300 patients and the primary endpoint will be change in pulmonary function (FEV-1) measured after three 28 day on-treatment and three 28 day off-treatment cycles (about six months). A key secondary endpoint will be time to pulmonary exacerbation. The study's Principal Investigator is Diana Bilton, M.D., Director of Adult CF Centre at the Royal Brompton Hospital in London, England.