AIR-CF1: Respiratory Symptoms Clinical Data

CAYSTON improved respiratory symptoms such as coughing, wheezing, and sputum production as measured by CFQ-R* score

  • The CAYSTON Prescribing Information does not present quantitative data on changes in CFQ-R
  • The FDA determined the CFQ-R was not validated in accordance with its Guidance for Industry: Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims5
  • CFQ-R score has not been shown to correlate directly with a change in FEV15
CAYSTON AIR-CF1: Respiratory Symptoms
  • Improvement in respiratory symptoms was noted for CAYSTON-treated patients vs placebo on the last day of drug treatment (9.7 points; 95% CI; 4.3, 15.1; p<0.001)1
  • Statistically significant improvements were seen in adults and pediatric patients, but were substantially smaller in adults
  • A difference in respiratory symptoms between treatment groups was present 2 weeks after completion of treatment, although the difference was smaller (6.3 points; 95% CI: 1.2, 11.4; p=0.015)1

*Cystic Fibrosis Questionnaire-Revised.

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