Daily home spirometry: an effective tool for detecting progression in idiopathic pulmonary fibrosis
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Accepted version
Accepted version
Author(s)
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.
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.
Date Issued
2016-04-18
Date Acceptance
2016-04-18
Citation
American Journal of Respiratory and Critical Care Medicine, 2016, 194 (8), pp.989-997
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
National Institute for Health Research
NIHR Research for Patient Benefit Programme
Versus Arthritis
Identifier
https://www.atsjournals.org/doi/10.1164/rccm.201511-2152OC
Grant Number
BRU 6279
PB-PG-0712-28073
20719
Subjects
Science & Technology
Life Sciences & Biomedicine
Critical Care Medicine
Respiratory System
General & Internal Medicine
interstitial lung disease
clinical trials
biomarker
personalized medicine
FORCED VITAL CAPACITY
CLINICAL-COURSE
PIRFENIDONE
NINTEDANIB
MORTALITY
TRIALS
POINT
biomarker
clinical trials
interstitial lung disease
personalized medicine
Aged
Disease Progression
Female
Humans
Idiopathic Pulmonary Fibrosis
Male
Proportional Hazards Models
Self Care
Spirometry
Time Factors
Vital Capacity
Humans
Disease Progression
Vital Capacity
Spirometry
Self Care
Proportional Hazards Models
Time Factors
Aged
Female
Male
Idiopathic Pulmonary Fibrosis
11 Medical and Health Sciences
Respiratory System
Publication Status
Published
Date Publish Online
2016-04-18