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Original Research |

Lung clearance index in adults and children with cystic fibrosis

Katherine O’Neill, PhD; Michael M. Tunney, PhD; Elinor Johnston, PhD; Stephen Rowan, PhD, MD; Damian G. Downey, MD; Jacqueline Rendall, MD; Alastair Reid, MD; Ian Bradbury, PhD; J. Stuart Elborn, PhD, MD; Judy. M. Bradley, PhD
Author and Funding Information

KON, MMT, JSE and JB have received grant support from the Northern Ireland Research and Development Division, EU Framework 7 and the Medical Research Council to support this work. All others declare no conflicts of interest.

This work was funded by the Health and Social Care Research and Development Division, Public Health Agency, Northern Ireland and the Medical Research Council through a US-Ireland Partnership Grant.

1Centre for Infection and Immunity, School of Medicine, Dentistry and Biomedical Sciences, Queen’s University Belfast, United Kingdom

2School of Pharmacy, Queen’s University Belfast, United Kingdom

3South Eastern Health and Social Care Trust, Belfast, United Kingdom

4Belfast Health and Social Care Trust, Belfast, United Kingdom

5Frontier Science (Scotland) Ltd, United Kingdom

6Clinical Research Facility, Queen’s University Belfast, United Kingdom

Corresponding author: Katherine O’Neill. Centre for Infection and Immunity, 3rd Floor, Medical Biology Centre, Lisburn Road, Queen's University Belfast, BT9 7BL..


Copyright 2016, . All Rights Reserved.


Chest. 2016. doi:10.1016/j.chest.2016.06.029
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Abstract

Background  Lung clearance index (LCI) has good clinimetric properties and an acceptable feasibility profile as a surrogate endpoint in Cystic Fibrosis (CF). Although most studies to date have been in children, increasing numbers of adults with CF also have normal spirometry. Further study of LCI as an endpoint in CF adults is required. Therefore, the purpose of this study was to determine the clinimetric properties of LCI over the complete age range of people with CF.

Methods  Clinically stable adults and children with CF and age matched healthy controls were recruited.

Results  LCI and spirometry data for 110 CF subjects and 61 controls were collected at a stable visit. CF Questionnaire-Revised (CFQ-R) was completed by 80/110 CF subjects. Fifty-six CF subjects completed a second stable visit. The LCI CV% was 4.1% in adults and 6.3% in children with CF. The coefficient of repeatability of LCI was 1.2 in adults and 1.3 in children. In both adults and children, LCI (AUCROC=0.93 and 0.84) had greater combined sensitivity and specificity to discriminate between people with CF and controls compared to FEV1 (AUCROC=0.88 and 0.60) and FEF25-75 (AUCROC=0.87 and 0.68). LCI correlated significantly with the CFQ-R treatment burden in adults (r=-0.37; p<0.01) and children (r=-0.50; p<0.01). Washout tests were successful in 90% of CF subjects and were perceived as comfortable and easy to perform in both adults and children.

Conclusions  These data support the use of LCI as a surrogate outcome measure in CF clinical trials in adults as well as children.


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