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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 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.
Original language | English |
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Article number | 180108 |
Pages (from-to) | 1-14 |
Number of pages | 14 |
Journal | European Respiratory Review |
Volume | 28 |
Issue number | 151 |
Early online date | 14 Mar 2019 |
DOIs | |
Publication status | Published - 31 Mar 2019 |
Keywords
- Bronchiectasis/diagnosis
- Clinical Trials as Topic/methods
- Disease Progression
- Endpoint Determination/standards
- Humans
- Lung/drug effects
- Quality of Life
- Recovery of Function
- Research Design/standards
- Respiratory System Agents/adverse effects
- Treatment Outcome
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Dive into the research topics of 'A systematic review of pharmacotherapeutic clinical trial end-points for bronchiectasis in adults'. Together they form a unique fingerprint.Projects
- 1 Finished
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Inhaled Antibiotics in Bronchiectasis and Cystic Fibrosis (iABC) (Joint with 19 Partners)
Chalmers, J. (Investigator) & Shoemark, A. (Investigator)
COMMISSION OF THE EUROPEAN COMMUNITIES
1/09/15 → 30/06/23
Project: Research