title: Pulmonary exacerbation: towards a definition for use in clinical trials. Report from the EuroCareCF Working Group on outcome parameters in clinical trials.
abstract: Pulmonary exacerbations represent a key outcome variable in clinical trials of cystic fibrosis (CF). As there is variation in the trigger for use of intravenous antibiotics compared to the use of oral antibiotics or new nebulised therapy for treatment of exacerbations, the consensus view is that use of intravenous antibiotics cannot be regarded as the key defining character for an exacerbation on its own. The consensus view is that the clinical need for additional treatment as indicated by a recent change in clinical parameters provides the best definition of an exacerbation. Which parameters to include as well as the problems associated with the use of scoring systems and symptom clusters are being discussed.
authors.affiliation: Royal Brompton Hospital, Respiratory Medicine, London, UK. D.Bilton@rbht.nhs.uk
authors.forename: D
authors.initials: D
authors.lastname: Bilton
authors.forename: G
authors.initials: G
authors.lastname: Canny
authors.forename: S
authors.initials: S
authors.lastname: Conway
authors.forename: S
authors.initials: S
authors.lastname: Dumcius
authors.forename: L
authors.initials: L
authors.lastname: Hjelte
authors.forename: M
authors.initials: M
authors.lastname: Proesmans
authors.forename: B
authors.initials: B
authors.lastname: Tümmler
authors.forename: V
authors.initials: V
authors.lastname: Vavrova
authors.forename: K
authors.initials: K
authors.lastname: De Boeck
mesh_terms: D000900:Anti-Bacterial Agents / Q000627:therapeutic use*; D002986:Clinical Trials as Topic / Q000379:methods*; D003550:Cystic Fibrosis / Q000382:microbiology / Q000503:physiopathology / Q000628:therapy; D018450:Disease Progression; D005060:Europe; D006801:Humans; D018410:Pneumonia, Bacterial / Q000188:drug therapy* / Q000503:physiopathology*
chemical_list: D000900:Anti-Bacterial Agents