V Thompson1, N Mayer-Hamblett2, M Kloster3, D Bilton4, P A Flume5. 1. Seattle Children's Research Institute, 2001 8th Ave Ste 400, Seattle, WA 98145-5005, United States. Electronic address: valeria.thompson@seattlechildrens.org. 2. Seattle Children's Research Institute, 2001 8th Ave Ste 400, Seattle, WA 98145-5005, United States; Department of Biostatistics, University of Washington, Seattle, WA, United States; Department of Pediatrics, University of Washington, 4800 Sand Point Way N.E., Box 5371, Seattle, WA 98105-0371, United States. Electronic address: nicole.hamblett@seattlechildrens.org. 3. Seattle Children's Research Institute, 2001 8th Ave Ste 400, Seattle, WA 98145-5005, United States. Electronic address: margaret.kloster@seattlechildrens.org. 4. Department of Respiratory Medicine, Royal Brompton Hospital, Sydney Street, London SW3 6NP, United Kingdom. Electronic address: d.bilton@rbht.nhs.uk. 5. Medical University of South Carolina, 96 Jonathan Lucas St., Room 812-CSB, Charleston, SC 29425, United States. Electronic address: flumepa@musc.edu.
Abstract
BACKGROUND: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. METHODS: This retrospective cohort study estimated hemoptysis rates overall and by relevant risk factors utilizing adverse event data from longitudinal prospective CF clinical trials. RESULTS: 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. CONCLUSIONS: 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.
RCT Entities:
BACKGROUND: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. METHODS: This retrospective cohort study estimated hemoptysis rates overall and by relevant risk factors utilizing adverse event data from longitudinal prospective CF clinical trials. RESULTS: 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. CONCLUSIONS: 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.
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