Design and powering of cystic fibrosis clinical trials using pulmonary exacerbation as an efficacy endpoint.

@article{VanDevanter2011DesignAP,
  title={Design and powering of cystic fibrosis clinical trials using pulmonary exacerbation as an efficacy endpoint.},
  author={Donald R VanDevanter and Ashley Yegin and Wayne J Morgan and Stefanie J Millar and David J Pasta and Michael W Konstan},
  journal={Journal of cystic fibrosis : official journal of the European Cystic Fibrosis Society},
  year={2011},
  volume={10 6},
  pages={453-9}
}
BACKGROUND Reduction in pulmonary exacerbations is an important efficacy endpoint for CF clinical studies. Powering exacerbation endpoints requires estimation of the future exacerbation incidence in CF study populations, but rates differ across the population. METHODS We have estimated exacerbation rates for Epidemiologic Study of CF subpopulations stratified by age, FEV(1)% predicted, sex, weight-for-age percentile, respiratory signs and symptoms, and history of exacerbation and bacterial… CONTINUE READING
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