Changes in symptom scores as a potential clinical endpoint for studies of cystic fibrosis pulmonary exacerbation treatment |
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| Authors: | DR VanDevanter SL Heltshe DB Sanders NE West M Skalland PA Flume CH Goss |
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| Affiliation: | 1. Department of Pediatrics, Case Western Reserve University School of Medicine, Cleveland, OH, United States;2. CFF Therapeutics Development Network Coordinating Center, Seattle Children''s Research Institute, Seattle, WA, United States;3. Departments of Pediatrics, University of Washington, Seattle, WA, United States;4. Department of Pediatrics, Indiana University School of Medicine, Indianapolis, IN, United States;5. Department of Medicine, Johns Hopkins University, Baltimore, MD, United States;6. Departments of Medicine and Pediatrics, Medical University of South Carolina, Charleston, SC, United States;7. Department of Medicine, University of Washington, Seattle, WA, United States |
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| Abstract: | Introduction: Symptom improvement was assessed as changes in the Chronic Respiratory Infection Symptom Score (CRISS) during intravenous antimicrobial exacerbation treatments among subjects from study NCT02109822.Methods: Median daily CRISS reduction (i.e., improvement) and covariates associated with CRISS reduction by Day 14 were assessed by logistic regression.Results: Among 173 subjects, median baseline CRISS was 49 [IQR 41, 56]; 93.6% had a CRISS reduction of ≥11 (minimal clinically important difference); median time to –11 reduction was 2 days [95% CI 2, 3]. The greatest median CRISS difference from baseline, on Day 17, was –26 [–29, –23]. Odds of –26 CRISS change by Day 14 were greater in subjects with higher baseline CRISS (P=.006) and younger ages (P=.041).Conclusions: CRISS response has good dynamic range and may be a useful efficacy endpoint for PEx interventional trials. The optimal use of CRISS change as an endpoint remains uncharacterized. |
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