TY - JOUR
T1 - Pulmonary exacerbation in adults with bronchiectasis
T2 - a consensus definition for clinical research
AU - EMBARC/BRR definitions working group
AU - Hill, Adam T.
AU - Haworth, Charles S.
AU - Aliberti, Stefano
AU - Barker, Alan
AU - Blasi, Francesco
AU - Boersma, Wim
AU - Chalmers, James D.
AU - De Soyza, Anthony
AU - Dimakou, Katerina
AU - Elborn, J. Stuart
AU - Feldman, Charles
AU - Flume, Patrick
AU - Goeminne, Pieter C.
AU - Loebinger, Michael R.
AU - Menendez, Rosario
AU - Morgan, Lucy
AU - Murris, Marlene
AU - Polverino, Eva
AU - Quittner, Alexandra
AU - Ringshausen, Felix C.
AU - Tino, Gregory
AU - Torres, Antoni
AU - Vendrell, Montserrat
AU - Welte, Tobias
AU - Wilson, Rob
AU - Wong, Conroy
AU - O'Donnell, Anne
AU - Aksamit, Timothy
N1 - Publisher Copyright:
Copyright ©ERS 2017.
Copyright:
This record is sourced from MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
PY - 2017/6/1
Y1 - 2017/6/1
N2 - There is a need for a clear definition of exacerbations used in clinical trials in patients with bronchiectasis. An expert conference was convened to develop a consensus definition of an exacerbation for use in clinical research.A systematic review of exacerbation definitions used in clinical trials from January 2000 until December 2015 and involving adults with bronchiectasis was conducted. A Delphi process followed by a round-table meeting involving bronchiectasis experts was organised to reach a consensus definition. These experts came from Europe (representing the European Multicentre Bronchiectasis Research Collaboration), North America (representing the US Bronchiectasis Research Registry/COPD Foundation), Australasia and South Africa.The definition was unanimously approved by the working group as: a person with bronchiectasis with a deterioration in three or more of the following key symptoms for at least 48 h: cough; sputum volume and/or consistency; sputum purulence; breathlessness and/or exercise tolerance; fatigue and/or malaise; haemoptysis AND a clinician determines that a change in bronchiectasis treatment is required.The working group proposes the use of this consensus-based definition for bronchiectasis exacerbation in future clinical research involving adults with bronchiectasis.
AB - There is a need for a clear definition of exacerbations used in clinical trials in patients with bronchiectasis. An expert conference was convened to develop a consensus definition of an exacerbation for use in clinical research.A systematic review of exacerbation definitions used in clinical trials from January 2000 until December 2015 and involving adults with bronchiectasis was conducted. A Delphi process followed by a round-table meeting involving bronchiectasis experts was organised to reach a consensus definition. These experts came from Europe (representing the European Multicentre Bronchiectasis Research Collaboration), North America (representing the US Bronchiectasis Research Registry/COPD Foundation), Australasia and South Africa.The definition was unanimously approved by the working group as: a person with bronchiectasis with a deterioration in three or more of the following key symptoms for at least 48 h: cough; sputum volume and/or consistency; sputum purulence; breathlessness and/or exercise tolerance; fatigue and/or malaise; haemoptysis AND a clinician determines that a change in bronchiectasis treatment is required.The working group proposes the use of this consensus-based definition for bronchiectasis exacerbation in future clinical research involving adults with bronchiectasis.
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U2 - 10.1183/13993003.00051-2017
DO - 10.1183/13993003.00051-2017
M3 - Article
C2 - 28596426
AN - SCOPUS:85030033042
VL - 49
JO - European Respiratory Journal
JF - European Respiratory Journal
SN - 0903-1936
IS - 6
ER -