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Daily home spirometry: an effective tool for detecting progression in idiopathic pulmonary fibrosis

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Title: Daily home spirometry: an effective tool for detecting progression in idiopathic pulmonary fibrosis
Authors: Russell, AM
Adamali, H
Molyneaux, PL
Lukey, PT
Marshall, RP
Renzoni, EA
Wells, AU
Maher, TM
Item Type: Journal Article
Abstract: Rationale: Recent clinical trial successes have created an urgent need for earlier and more sensitive endpoints of disease progression in idiopathic pulmonary fibrosis (IPF). Domiciliary spirometry permits more frequent measurement of FVC than does hospital-based assessment, which therefore affords the opportunity for a more granular insight into changes in IPF progression. Objectives: To determine the feasibility and reliability of measuring daily FVC in individuals with IPF. Methods: Subjects with IPF were given handheld spirometers and instruction on how to self-administer spirometry. Subjects recorded daily FEV1 and FVC for up to 490 days. Clinical assessment and hospital-based spirometry was undertaken at 6 and 12 months, and outcome data were collected for 3 years. Measurements and Main Results: Daily spirometry was recorded by 50 subjects for a median period of 279 days (range, 13–490 d). There were 18 deaths during the active study period. Home spirometry showed excellent correlation with hospital-obtained readings. The rate of decline in FVC was highly predictive of outcome and subsequent mortality when measured at 3 months (hazard ratio [HR], 1.040; 95% confidence interval [CI], 1.021–1.062; P ≤ 0.001), 6 months (HR, 1.024; 95% CI, 1.014–1.033; P < 0.001), and 12 months (HR, 1.012; 95% CI, 1.007–1.016; P = 0.001). Conclusions: Measurement of daily home spirometry in patients with IPF is highly clinically informative and is feasible to perform for most of these patients. The relationship between mortality and rate of change of FVC at 3 months suggests that daily FVC may be of value as a primary endpoint in short proof-of-concept IPF studies.
Issue Date: 18-Apr-2016
Date of Acceptance: 18-Apr-2016
URI: http://hdl.handle.net/10044/1/32186
DOI: https://dx.doi.org/10.1164/rccm.201511-2152OC
ISSN: 1535-4970
Publisher: American Thoracic Society
Start Page: 989
End Page: 997
Journal / Book Title: American Journal of Respiratory and Critical Care Medicine
Volume: 194
Issue: 8
Copyright Statement: Copyright © 2016 by the American Thoracic Society. The final publication is available at http://dx.doi.org/10.1164/rccm.201511-2152OC
Sponsor/Funder: National Institute for Health Research
NIHR Research for Patient Benefit Programme
Funder's Grant Number: BRU 6535
PB-PG-0712-28073
Keywords: biomarker
clinical trials
interstitial lung disease
personalized medicine
Respiratory System
11 Medical And Health Sciences
Publication Status: Published
Appears in Collections:National Heart and Lung Institute
Faculty of Medicine



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