Abstract
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).
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.
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 to 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).
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.
Footnotes
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Conflict of interest: Dr. Murray reports personal fees from AstraZeneca, personal fees from Thermo Fisher, personal fees from Boehringer Ingelheim, personal fees from GSK, personal fees from Novartis, outside the submitted work.
Conflict of interest: Dr. Noth reports personal fees from Boehringer Ingelheim, personal fees from Genentech, personal fees from ImmuneWorks, outside the submitted work;.
Conflict of interest: Dr. Cottin reports personal fees and non-financial support from Actelion, grants, personal fees and non-financial support from Boehringer Ingelheim, personal fees from Bayer / MSD, personal fees from Novartis, personal fees and non-financial support from Roche, personal fees from Sanofi, personal fees from Promedior, personal fees from Celgene, personal fees from Galapagos, personal fees from Galecto, outside the submitted work;.
Conflict of interest: Dr. Chaudhuri reports grants from Roche, personal fees from Roche, other from Roche, grants from Boehringer Ingelheim, personal fees from Boehringer Ingelheim, other from Boehringer Ingelheim, outside the submitted work;.
Conflict of interest: Dr. Corte reports grants and personal fees from Boehringer Ingelheim, grants and personal fees from Roche, grants from Gilead, grants from Bayer, grants from Intermune, personal fees from AstraZeneca, grants and personal fees from BMS, personal fees from Promedior, personal fees from Ad Alta, from null, during the conduct of the study;.
Conflict of interest: Dr. Johannson reports personal fees and other from Boehringer-Ingelheim, personal fees and other from Hoffman La Roche Ltd, personal fees and other from Theravance, personal fees and other from Blade Therapeutics, grants from Chest Foundation, grants from University of Calgary School of Medicine, grants from Pulmonary Fibrosis Society of Calgary, grants from UCB Biopharma SPRL, other from Three Lakes Foundation , outside the submitted work;.
Conflict of interest: Dr. Wijsenbeek reports grants and personal fees from Boehringer Ingelheim and Hoffman La Roche , personal fees from Galapagos, outside the submitted work. This article was based on discussions held at a meeting supported by Boehringer Ingelheim in June 2017.
Conflict of interest: Dr. Jouneau reports personal fees from Actelion, personal fees from AIRB, personal fees from AstraZeneca, personal fees from Bristol-Myers Squibb, personal fees from Boehringer Ingelheim, personal fees from Chiesi, personal fees from Galecto , personal fees from Gilead, personal fees from GlaxoSmithKline, personal fees from LVL, personal fees from Mundipharma, personal fees from Novartis, personal fees from Pfizer, personal fees from Roche, personal fees from Savara-Serendex, outside the submitted work;.
Conflict of interest: The author (Andy Michael) is a contractor to Boehringer Ingelheim.
Conflict of interest: The author (Manuel Quaresma) is an employee of Boehringer Ingelheim International GmbH.
Conflict of interest: The author (Klaus Rohr) is an employee of Boehringer Ingelheim International GmbH.
Conflict of interest: Dr. Russell reports grants and personal fees from Boehringer Ingelheim , grants from Imperial Health Charity, grants from Pulmonary Fibrosis Trust UK, personal fees from Irish Lung Fibrosis Association, grants from Action for Pulmonary Fibrosis, personal fees from Hoffman La Roche, outside the submitted work;.
Conflict of interest: The author (Susanne Stowasser) is an employee of Boehringer Ingelheim International GmbH.
Conflict of interest: Dr. Maher reports personal fees from Apellis, personal fees from Boehringer Ingelheim, grants and personal fees from UCB, personal fees from Roche, personal fees from Bayer, personal fees from Biogen Idec, personal fees from Apellis, personal fees from Galapagos, personal fees from Indalo, personal fees from Galecto, personal fees from Blade, personal fees from Bristol-Myers Squibb, grants and personal fees from GlaxoSmithKline, personal fees from Novartis, personal fees from Respivent, personal fees from Trevi, outside the submitted work;.
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- Received May 1, 2020.
- Accepted December 9, 2020.
- Copyright ©ERS 2021
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