Hill AT,Haworth CS,Aliberti S,Barker A,Blasi F,Boersma W,Chalmers JD,De Soyza A,Dimakou K,Elborn JS,Feldman C,Flume P,Goeminne PC,Loebinger MR,Menendez R,Morgan L,Murris M,Polverino E, et al.

Link to publication page: http://erj.ersjournals.com/content/49/6/1700051

Journal Ref: EurRespirJ.2017Jun8;49(6)

Abstract:

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.