Task Force report: European Respiratory Society statement for defining respiratory exacerbations in children and adolescents with bronchiectasis for clinical trials

Bronchiectasis is being diagnosed increasingly in children and adolescents. Recurrent respiratory exacerbations are common in children and adolescents with this chronic pulmonary disorder. Respiratory exacerbations are associated with an impaired quality-of-life, poorer long-term clinical outcomes and substantial costs to the family and health systems. The European Respiratory Society (ERS) clinical practice guideline for the management of children and adolescents with bronchiectasis provided a definition of acute respiratory exacerbations for clinical use but to date there is no comparable universal definition for clinical research. Given the importance of exacerbations in the field, this ERS task force sought to obtain robust definitions of respiratory exacerbations for clinical research. The panel was a multidisciplinary team of specialists in paediatric and adult respiratory medicine, infectious disease, physiotherapy, primary care, nursing, radiology, methodology, patient advocacy and parents of children and adolescents with bronchiectasis. We used a standardised process that included a systematic literature review, parents’ survey and a Delphi involving 299 physicians (54 countries) caring for children and adolescents with bronchiectasis. Consensus was obtained for all four statements drafted by the panel as the disagreement rate was very low (range 3.6.4. The panel unanimously endorsed the four consensus definitions for: non-severe and severe exacerbations as an outcome measure; non-severe exacerbation for studies initiating treatment and; resolution of a non-severe exacerbation; for clinical trials involving children and adolescents with bronchiectasis. This ERS task force proposes using these internationally derived, consensus-based definitions of respiratory exacerbations for future clinical paediatric bronchiectasis research.

Footnotes This manuscript has recently been accepted for publication in the European Respiratory Journal. It is published here in its accepted form prior to copyediting and typesetting by our production team. After these production processes are complete and the authors have approved the resulting proofs, the article will move to the latest issue of the ERJ online.

Conflict of Interest: Dr. Chang reports grants from National Health and Medical Research Council, Australia, during the conduct of the study; other from IDMC Member of an unlicensed vaccine (GSK), other from Advisory member of study design for unlicensed molecule for chronic cough (Merck), other from IDMC Member of an unlicensed monoclonal antibody (AstraZeneca), personal fees from being an author of two UpToDate chapters, outside the submitted work. Conflict of Interest: Angela Zacharasiewicz has nothing to disclose. Conflict of Interest: Dr. Goyal has nothing to disclose. Conflict of Interest: Ms. Boyd has nothing to disclose. Conflict of Interest: Dr E. Alexopoulou has nothing to discloseConflict of Interest: Dr. Aliberti reports grants and personal fees from INSMED Incorporated, grants and personal fees from CHIESI, grants from Fisher amp; Paykel, personal fees from McGRAW HILL, personal fees from INSMED Italy, personal fees from INSMED Ireland Ltd, personal fees from ZAMBON, personal fees from AstraZeneca UK Limited, personal fees from CSL Behring GmbH, personal fees from Grifols, personal fees from Fondazione Charta, personal fees from Boehringer Ingelheim, personal fees from ZCUBE Srl, personal fees from MENARINI, personal fees from GlaxoSmithKline Spa, outside the submitted work; . Conflict of Interest: Mrs Bell has nothing to disclose. Conflict of Interest: Dr. Bush has nothing to disclose. Conflict of Interest: Dr. Claydon has nothing to disclose. Conflict of Interest: Dr. Constant has nothing to disclose. Conflict of Interest: Dr. Fortescue has nothing to disclose. Conflict of Interest: Prof. Hill has nothing to disclose. Conflict of Interest: Dr. KARADAG has nothing to disclose. Conflict of Interest: Mrs Powell has nothing to disclose. Conflict of Interest: Dr. Wilson has nothing to disclose. Conflict of Interest: Dr. Grimwood reports grants from Australian National Health and Medical Research Council, and Medical Research Futures Fund, during the conduct of the study;Conflict of Interest: Dr. Kantar has nothing to disclose.