D R VanDevanter1, S L Heltshe2, D B Sanders3, N E West4, M Skalland5, P A Flume6, C H Goss7. 1. Department of Pediatrics, Case Western Reserve University School of Medicine, Cleveland, OH, United States. Electronic address: drv15@case.edu. 2. CFF Therapeutics Development Network Coordinating Center, Seattle Children's Research Institute, Seattle, WA, United States; Departments of Pediatrics, University of Washington, Seattle, WA, United States. 3. Department of Pediatrics, Indiana University School of Medicine, Indianapolis, IN, United States. 4. Department of Medicine, Johns Hopkins University, Baltimore, MD, United States. 5. CFF Therapeutics Development Network Coordinating Center, Seattle Children's Research Institute, Seattle, WA, United States. 6. Departments of Medicine and Pediatrics, Medical University of South Carolina, Charleston, SC, United States. 7. CFF Therapeutics Development Network Coordinating Center, Seattle Children's Research Institute, Seattle, WA, United States; Departments of Pediatrics, University of Washington, Seattle, WA, United States; Department of Medicine, University of Washington, Seattle, WA, United States.
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.
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.
Authors: Sonya L Heltshe; Natalie E West; Donald R VanDevanter; D B Sanders; Valeria V Beckett; Patrick A Flume; Christopher H Goss Journal: Contemp Clin Trials Date: 2017-11-21 Impact factor: 2.226
Authors: Don B Sanders; George M Solomon; Valeria V Beckett; Natalie E West; Cori L Daines; Sonya L Heltshe; Donald R VanDevanter; Jonathan E Spahr; Ronald L Gibson; Jerry A Nick; Bruce C Marshall; Patrick A Flume; Christopher H Goss Journal: J Cyst Fibros Date: 2017-04-29 Impact factor: 5.482
Authors: Laura S Gold; Donald L Patrick; Ryan N Hansen; Valeria Beckett; Christopher H Goss; Larry Kessler Journal: J Cyst Fibros Date: 2018-08-29 Impact factor: 5.482
Authors: Noah Lechtzin; Nicole Mayer-Hamblett; Natalie E West; Sarah Allgood; Ellen Wilhelm; Umer Khan; Moira L Aitken; Bonnie W Ramsey; Michael P Boyle; Peter J Mogayzel; Ronald L Gibson; David Orenstein; Carlos Milla; John P Clancy; Veena Antony; Christopher H Goss Journal: Am J Respir Crit Care Med Date: 2017-11-01 Impact factor: 21.405
Authors: D R VanDevanter; S L Heltshe; J Spahr; V V Beckett; C L Daines; E C Dasenbrook; R L Gibson; Jain Raksha; D B Sanders; C H Goss; P A Flume Journal: J Cyst Fibros Date: 2017-04-21 Impact factor: 5.482
Authors: D R VanDevanter; S L Heltshe; M Skalland; N E West; D B Sanders; C H Goss; P A Flume Journal: J Cyst Fibros Date: 2021-12-18 Impact factor: 5.527
Authors: Natalie Franz; Hannah Rapp; Ryan N Hansen; Laura S Gold; Christopher H Goss; Noah Lechtzin; Larry G Kessler Journal: J Cyst Fibros Date: 2021-03-12 Impact factor: 5.482
Authors: Alex H Gifford; Deepika Polineni; Jianghua He; Jessica L D'Amico; Dana B Dorman; Molly A Williams; Amanda B Nymon; Akshu Balwan; Theodore Budden; Jonathan B Zuckerman Journal: Sci Rep Date: 2021-03-01 Impact factor: 4.379