Lung Clearance Index Rationale Sample Clauses

Lung Clearance Index Rationale. Spirometric measures, such as forced expired volume in one second (FEV1), have traditionally been used in the assessment of CF lung disease due to their direct correlation with morbidity and mortality15 . However, FEV1 tends to remain within normal limits in a high percentage of patients, despite radiographic evidence of airway damage.16 This is likely due to the fact that these measures are primarily influenced by resistive changes in the large airways and thus not reflective of the patchy distribution of small airway pathology characteristic of early CF lung disease. The LCI, as measured by multiple breath washouts, reflects global ventilation inhomogeneity and as such is a highly sensitive marker for early obstructive lung disease.17-19 Furthermore, LCI is more sensitive than other measures of lung function in detecting structural changes identified by high resolution CT imaging.20-22 Importantly, LCI tracks from preschool to school-age and was found to precede subsequent abnormalities in spirometry indices23 and is independent of patient effort. Previous studies using interventions such as hypertonic saline and dornase alfa have demonstrated that fewer number of CF subjects are required to detect a treatment effect using LCI in comparison with spirometric measures.24, 25 This was supported by a multicenter study with ivacaftor in CF patients carrying at least one G551D allele; where LCI improved significantly in ivacaftor treated patients.26 Post-hoc analyses showed that the number of subjects required to demonstrate a treatment effect was about 1/3 of that required for a study using FEV1 as an outcome measure. Multiple breath washout (MBW) testings will be performed in a subset of subjects enrolled in the Part B CORE study to evaluate the suitability of LCI as an outcome measure to detect and track treatment effects in patients receiving CFTR directed pharmacotherapy.
Sample 1
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