A systematic review of pharmacotherapeutic clinical trial end-points for bronchiectasis in adults.

ABSTRACT: Bronchiectasis is an increasing clinical problem, but multiple recent clinical trials have failed to reach their primary end-point. Difficulties in achieving "positive" bronchiectasis trials is reflected in a lack of agreement from trialists and regulators on what are the optimal end-points.To evaluate the use of end-points in bronchiectasis trials, we conducted a systematic review of published bronchiectasis trials from 2008 to 2018 and extracted end-points used, definitions, methods of analysis and responsiveness.Our analysis shows that quality of life and exacerbation end-points are most frequently used. Trials using exacerbation end-points have been characterised by varying definitions, multiple methods of analysis and durations of follow-up. There are multiple quality of life tools fo

SUBMITTER: Crichton ML 

PROVIDER: S-EPMC9488648 | biostudies-literature | 2019 Mar

REPOSITORIES: biostudies-literature