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Bronchiectasis Trials Should Be Longer, Focus On Exacerbation Frequency

 
• By Sue Sutter

Bayer's endpoint for Phase III trials of ciprofloxacin inhaler should have focused on frequency of, rather than delay in, exacerbations, US FDA advisory committee members say; Aradigm's pending NDA in non-cystic fibrosis bronchiectasis could be impacted recommendations on endpoints, trial duration and concerns about long-term development of antibiotic resistance.

Render illustration of Clinical Trial title on medical documents

US FDA advisory committee members thought the Phase III trials for Bayer HealthCare Pharmaceuticals AG's inhalable ciprofloxacin in non-cystic fibrosis bronchiectasis (NCFB) could have been better designed, and their recommendations on endpoints and duration of future studies could impact other biopharma sponsors targeting this rare disease setting.

Late-stage trials in NCFB should be longer, with a greater emphasis on reducing the frequency of exacerbations and assessing the...

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