Risk of hemoptysis in cystic fibrosis clinical trials: A retrospective cohort study.
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.
Seattle Children's Research Institute, 2001 8th Ave Ste 400, Seattle, WA 98145-5005, United States. Electronic address: valeria.thompson@seattlechildrens.org.
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Thompson
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.
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Mayer-Hamblett
Seattle Children's Research Institute, 2001 8th Ave Ste 400, Seattle, WA 98145-5005, United States. Electronic address: margaret.kloster@seattlechildrens.org.
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Kloster
Department of Respiratory Medicine, Royal Brompton Hospital, Sydney Street, London SW3 6NP, United Kingdom. Electronic address: d.bilton@rbht.nhs.uk.
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Bilton
Medical University of South Carolina, 96 Jonathan Lucas St., Room 812-CSB, Charleston, SC 29425, United States. Electronic address: flumepa@musc.edu.
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Flume
D000293:Adolescent; D000900:Anti-Bacterial Agents / Q000009:adverse effects*; D001424:Bacterial Infections / Q000150:complications* / Q000188:drug therapy; D002648:Child; D003550:Cystic Fibrosis / Q000150:complications* / Q000503:physiopathology / Q000628:therapy; D005260:Female; D005500:Follow-Up Studies; D005540:Forced Expiratory Flow Rates; D006469:Hemoptysis / Q000453:epidemiology* / Q000209:etiology; D006801:Humans; D015994:Incidence; D008297:Male; D026741:Physical Therapy Modalities / Q000009:adverse effects*; D012189:Retrospective Studies; D018570:Risk Assessment / Q000379:methods*; D012307:Risk Factors; D013997:Time Factors; D006113:United Kingdom / Q000453:epidemiology; D014481:United States / Q000453:epidemiology
D000900:Anti-Bacterial Agents
Clinical trial; Cystic fibrosis; Hemoptysis