Regulatory aspects of Phase 3 endpoints for new inhaled antibiotics for cystic fibrosis patients with chronic Pseudomonas aeruginosa infections.

Available regulatory guidelines for developing inhaled anti-infective therapies offer general advice, but specific guidance often provides conflicting and outdated advice in regard to clinical trial design. For instance, the availability of two approved drugs makes the conduct of placebo-controlled trials longer than 28 days problematic. Comparator drugs require use per the product label, making comparator trials difficult to blind as taste, foaming, regimen, device, and delivery time differences are present.