BACKGROUND: Lung clearance index (LCI) detects early ventilation inhomogeneity and has been suggested as sensitive endpoint in multicenter intervention trials in infants and preschoolers with cystic fibrosis (CF). However, the feasibility of multicenter LCI in this age group has not been determined. We, therefore, investigated the feasibility of LCI in infants and preschoolers with and without CF in a three-center setting. METHODS: Following central training, standardized SF6-MBW measurements were performed in 73 sedated children (10 controls, 49 with CF and 14 with other lung diseases), mean age 2.3+/-1.2years across three centers, and data were analyzed centrally. RESULTS: Overall success rate of LCI measurements was 91.8% ranging from 78.9% to 100% across study sites. LCI was increased in patients with CF (P<0.05) and with other lung diseases (P<0.05) compared to controls. CONCLUSION: Our results support feasibility of LCI as multicenter endpoint in clinical trials in infants and preschoolers with CF.
- Stahl, M.
- Graeber, S. Y.
- Joachim, C.
- Barth, S.
- Ricklefs, I.
- Diekmann, G.
- Kopp, M. V.
- Naehrlich, L.
- Mall, M. A.
Keywords
- Clinical trial endpoint
- Early CF lung disease
- Infant lung function test
- Lung clearance index
- Multiple breath washout
