Lung clearance index: Evidence for use in clinical trials in cystic fibrosis

• Published in: Journal of cystic fibrosis 2014-03, Vol.13 (2), p.123-138
• Main Authors: Kent, L, Reix, P, Innes, J.A, Zielen, S, Le Bourgeois, M, Braggion, C, Lever, S, Arets, H.G.M, Brownlee, K, Bradley, J.M, Bayfield, K, O'Neill, K, Savi, D, Bilton, D, Lindblad, A, Davies, J.C, Sermet, I, De Boeck, K
• Format: Article
• Language: English
• Subjects: Biomarkers; Breath Tests - methods; Clinimetric properties; Cystic Fibrosis - diagnosis; Cystic Fibrosis - physiopathology; Cystic Fibrosis - therapy; Feasibility Studies; Humans; Lung clearance index; Multiple breath washout; Outcome Assessment (Health Care) - methods; Outcome Assessment (Health Care) - standards; Outcome measures; Pulmonary/Respiratory; Randomized Controlled Trials as Topic - methods; Reproducibility of Results; Respiratory Function Tests - methods; Respiratory Function Tests - standards; Severity of Illness Index; Surrogate endpoints
• ISSN: 1569-1993; 1873-5010
• DOI: 10.1016/j.jcf.2013.09.005

Abstract The ECFS-CTN Standardisation Committee has undertaken this review of lung clearance index as part of the group's work on evaluation of clinical endpoints with regard to their use in multicentre clinical trials in CF. The aims were 1) to review the literature on reliability, validity and responsiveness of LCI in patients with CF, 2) to gain consensus of the group on feasibility of LCI and 3) to gain consensus on answers to key questions regarding the promotion of LCI to surrogate endpoint status. It was concluded that LCI has an attractive feasibility and clinimetric properties profile and is particularly indicated for multicentre trials in young children with CF and patients with early or mild CF lung disease. This is the first article to collate the literature in this manner and support the use of LCI in clinical trials in CF.