PT - JOURNAL ARTICLE AU - Megan L. Crichton AU - Stefano Aliberti AU - James D. Chalmers TI - A systematic review of pharmacotherapeutic clinical trial end-points for bronchiectasis in adults AID - 10.1183/16000617.0108-2018 DP - 2019 Mar 31 TA - European Respiratory Review PG - 180108 VI - 28 IP - 151 4099 - http://err.ersjournals.com/content/28/151/180108.short 4100 - http://err.ersjournals.com/content/28/151/180108.full SO - EUROPEAN RESPIRATORY REVIEW2019 Mar 31; 28 AB - 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 for bronchiectasis (Quality of Life – Bronchiectasis questionnaire, St George's Respiratory Questionnaire, etc.). The majority of studies measure lung function (e.g. forced expiratory volume in 1 s), but this is shown to be nonresponsive to the majority of interventions. Microbiology end-points frequently show statistically significant differences in phase 2 antibiotic studies but their correlation with clinical end-points is unknown.This systematic review demonstrates a need for guidance to standardise definitions and design features to improve reproducibility and increase the likelihood of demonstrating statistically significant benefits with new therapies.There is an urgent need to standardise clinical trial end-points in bronchiectasis. This systematic review shows the diversity of end-points used in bronchiectasis and suggests approaches that may improve the success rate and reproducibility of trials. http://ow.ly/d4HR30nvvS3