Risk of hemoptysis in cystic fibrosis clinical trials: A retrospective cohort study

Journal of Cystic Fibrosis : Official Journal of the European Cystic Fibrosis Society
V ThompsonP A Flume

Abstract

Cystic fibrosis (CF) is characterized by airway infection and inflammation resulting in respiratory complications including hemoptysis. The objectives of this study were to characterize the risk of hemoptysis attributable to underlying disease and in the presence of standard of care therapy. This retrospective cohort study estimated hemoptysis rates overall and by relevant risk factors utilizing adverse event data from longitudinal prospective CF clinical trials. Of the 1008 participants, 73% were ≤18 years old; of 929 with available spirometry, 27% had an FEV1<70% predicted. During the average 8.2 months of follow-up, 8% experienced ≥1 hemoptysis events (95% CI: 6%, 10%). Of the 125 events, 76% were mild in severity and only 9% were serious. Hemoptysis rates were greater among adults than children, those with FEV1<70% predicted, and participants infected with P. aeruginosa but not with S. aureus. Hemoptysis is a common adverse event among CF clinical trial participants, and particularly in adults with more severe lung disease. These results can be used to predict event occurrence in future clinical trials.

References

Jun 17, 1995·BMJ : British Medical Journal·D S ArmstrongP D Phelan
Jul 1, 1994·American Journal of Respiratory and Critical Care Medicine·P BirrerR G Crystal
Jan 5, 1999·American Journal of Respiratory and Critical Care Medicine·J L HankinsonK B Fedan
Oct 2, 2003·JAMA : the Journal of the American Medical Association·Lisa SaimanUNKNOWN Macrolide Study Group
Aug 16, 2005·Chest·Patrick A FlumeLeslie L Clark
Aug 1, 2006·Contemporary Clinical Trials·Heidi SucharewUNKNOWN Cystic Fibrosis Therapeutics Development Network
Feb 6, 2008·Journal of Cystic Fibrosis : Official Journal of the European Cystic Fibrosis Society·Ori EfratiDalit Modan-Moses
May 6, 2010·JAMA : the Journal of the American Medical Association·Lisa SaimanUNKNOWN AZ0004 Azithromycin Study Group
Nov 4, 2011·The New England Journal of Medicine·Bonnie W RamseyUNKNOWN VX08-770-102 Study Group
Jun 12, 2012·Pediatric Pulmonology·Lisa SaimanUNKNOWN AZ0004 Macrolide Study Team
Oct 17, 2012·Paediatric Respiratory Reviews·K Hurt, N J Simmonds

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Citations

Jun 2, 2020·Journal of Clinical Pharmacy and Therapeutics·Elizabeth Gavioli, Cho Cho Aung
Mar 16, 2017·Cardiovascular and Interventional Radiology·W G FlightA M Jones
Dec 19, 2018·ELife·Sandra Breum AndersenAshleigh S Griffin
Jul 2, 2019·Journal of Cystic Fibrosis : Official Journal of the European Cystic Fibrosis Society·Don B SandersWayne J Morgan
Mar 16, 2021·Journal of Cystic Fibrosis : Official Journal of the European Cystic Fibrosis Society·Patrick A FlumeMoira L Aitken
Mar 18, 2021·Hospital Practice·Elizabeth Marie GavioliMatthew Harrington
Mar 23, 2021·Journal of Cystic Fibrosis : Official Journal of the European Cystic Fibrosis Society·Jessica E PittmanDon B Sanders

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