Sanja Stanojevic1, Renee Jensen2, Dasiga Sundaralingam2, Juliana Giraldo Salazar2, Sophie Yammine3, Florian Singer4, Philipp Latzin5, Reshma Amin6, Padmaja Subbarao7, Per Gustafsson8, Felix Ratjen7. 1. Division of Respiratory Medicine, Department of Pediatrics, Hospital for Sick Children, Toronto, Canada; Physiology and Experimental Medicine, Research Institute, Hospital for Sick Children, Toronto, Canada; University of Toronto, Canada. Electronic address: Sanja.Stanojevic@sickkids.ca. 2. Division of Respiratory Medicine, Department of Pediatrics, Hospital for Sick Children, Toronto, Canada. 3. University Children's Hospital Bern, 3010 Bern, Switzerland. 4. University Children's Hospital Bern, 3010 Bern, Switzerland.; University Children's Hospital Zurich, 8032 Zurich, Switzerland. 5. University Children's Hospital Bern, 3010 Bern, Switzerland.; University Children's Hospital Basel, UKBB, 4031 Basel, Switzerland. 6. Division of Respiratory Medicine, Department of Pediatrics, Hospital for Sick Children, Toronto, Canada; University of Toronto, Canada. 7. Division of Respiratory Medicine, Department of Pediatrics, Hospital for Sick Children, Toronto, Canada; Physiology and Experimental Medicine, Research Institute, Hospital for Sick Children, Toronto, Canada; University of Toronto, Canada. 8. Department of Pediatrics, Central Hospital, Skövde, Sweden.
Abstract
BACKGROUND: The lung clearance index (LCI) measured by multiple-breath washout (MBW) has been proposed as an outcome for clinical trials; however, MBW is time consuming and LCI can be affected by breathing pattern. We aimed to evaluate moment ratios and abbreviated LCI in school-aged children with mild-to-moderate CF lung disease. METHODS: Using existing data from three studies we assessed the sensitivity of moment ratios and abbreviated LCIs to (i) detect mild-to-moderate CF lung disease and (ii) detect treatment effects after 4 weeks of hypertonic saline or dornase alfa inhalation. MBW was measured by respiratory mass spectrometry using 4% ""sulphur hexafluoride as a tracer gas. RESULTS: Compared to the traditional LCI, moment ratios and abbreviated LCIs were similarly sensitive to detect CF lung disease. Moment ratios consistently demonstrated treatment effects, whereas abbreviated LCIs were less sensitive. CONCLUSIONS: Both moment ratios and abbreviated LCI are suitable to differentiate health from disease. Sensitivity is decreased for abbreviated LCIs in interventional studies in mild CF lung disease.
RCT Entities:
BACKGROUND: The lung clearance index (LCI) measured by multiple-breath washout (MBW) has been proposed as an outcome for clinical trials; however, MBW is time consuming and LCI can be affected by breathing pattern. We aimed to evaluate moment ratios and abbreviated LCI in school-aged children with mild-to-moderate CF lung disease. METHODS: Using existing data from three studies we assessed the sensitivity of moment ratios and abbreviated LCIs to (i) detect mild-to-moderate CF lung disease and (ii) detect treatment effects after 4 weeks of hypertonic saline or dornase alfa inhalation. MBW was measured by respiratory mass spectrometry using 4% ""sulphur hexafluoride as a tracer gas. RESULTS: Compared to the traditional LCI, moment ratios and abbreviated LCIs were similarly sensitive to detect CF lung disease. Moment ratios consistently demonstrated treatment effects, whereas abbreviated LCIs were less sensitive. CONCLUSIONS: Both moment ratios and abbreviated LCI are suitable to differentiate health from disease. Sensitivity is decreased for abbreviated LCIs in interventional studies in mild CF lung disease.
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