Abstract
Background Data from the INMARK trial were used to investigate the feasibility and validity of home spirometry as a measure of lung function decline in patients with idiopathic pulmonary fibrosis (IPF). Methods Subjects with IPF and preserved forced vital capacity (FVC) were randomised to receive nintedanib or placebo for 12 weeks followed by open-label nintedanib for 40 weeks. Clinic spirometry was conducted at baseline and weeks 4, 8, 12, 16, 20, 24, 36 and 52. Subjects were asked to perform home spirometry at least once a week and ideally daily. Correlations between home- and clinic-measured FVC and rates of change in FVC were assessed using Pearson correlation coefficients. Results In total, 346 subjects were treated. Mean adherence to weekly home spirometry decreased over time but remained above 75% in every 4-week period. Over 52 weeks, mean adherence was 86%. Variability in change from baseline in FVC was greater when measured by home rather than clinic spirometry. Strong correlations were observed between home- and clinic-measured FVC at all time-points (r=0.72-0.84), but correlations between home- and clinic-measured rates of change in FVC were weak (r=0.26 for rate of decline in FVC over 52 weeks). Conclusion Home spirometry was a feasible and valid measure of lung function in patients with IPF and preserved FVC, but estimates of the rate of FVC decline obtained using home spirometry were poorly correlated with those based on clinic spirometry.
| Original language | English |
|---|---|
| Article number | 2001518 |
| Journal | European Respiratory Journal |
| Volume | 58 |
| Issue number | 1 |
| DOIs | |
| Publication status | Published - 1 Jul 2021 |
Bibliographical note
Funding Information:Support statement: The INMARK trial was funded by Boehringer Ingelheim. Funding information for this article has been deposited with the Crossref Funder Registry.
Acknowledgements: The authors thank the patients who participated in this trial. The authors did not receive payment for development of this manuscript. Writing assistance was provided by Julie Fleming and Wendy Morris of FleishmanHillard Fishburn (London, UK), which was contracted and funded by Boehringer Ingelheim. Boehringer Ingelheim was given the opportunity to review the manuscript for medical and scientific accuracy as well as intellectual property considerations.
Publisher Copyright:
© ERS 2021