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Home spirometry in patients with idiopathic pulmonary fibrosis: data from the INMARK trial

Imre Noth, Vincent Cottin, Nazia Chaudhuri, Tamera J Corte, Kerri A Johannson, Marlies Wijsenbeek, Stephane Jouneau, Andreas Michael, Manuel Quaresma, Klaus B Rohr, Anne-Marie Russell, Susanne Stowasser, Toby M Maher on behalf of the INMARK trial investigators
European Respiratory Journal 2021; DOI: 10.1183/13993003.01518-2020
Imre Noth
1Division of Pulmonary and Critical Care Medicine, University of Virginia, Charlottesville, Virginia, USA
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Vincent Cottin
2National Reference Centre for Rare Pulmonary Diseases, Louis Pradel Hospital, Hospices Civils de Lyon, Claude Bernard University Lyon 1, Lyon, France
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Nazia Chaudhuri
3North West Interstitial Lung Disease Unit, Manchester University Foundation Trust, Wythenshawe, Manchester, UK
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Tamera J Corte
4Royal Prince Alfred Hospital, Camperdown, New South Wales, Australia
5Australia and University of Sydney, New South Wales, Australia
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Kerri A Johannson
6Medicine & Community Health Sciences, University of Calgary, Calgary, Canada
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Marlies Wijsenbeek
7Department of Respiratory Medicine, Erasmus MC, University Medical Centre, Rotterdam, The Netherlands
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Stephane Jouneau
8Hôpital Pontchaillou - CHU de Rennes, IRSET UMR 1085, Université de Rennes 1, Rennes, France
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Andreas Michael
9Syneos Health, Farnborough, UK
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Manuel Quaresma
10Boehringer Ingelheim International GmbH, Ingelheim am Rhein, Germany
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Klaus B Rohr
10Boehringer Ingelheim International GmbH, Ingelheim am Rhein, Germany
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Anne-Marie Russell
11College of Medicine and Health University of Exeter, Exeter, UK
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Susanne Stowasser
10Boehringer Ingelheim International GmbH, Ingelheim am Rhein, Germany
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Toby M Maher
12National Heart and Lung Institute, Imperial College London, London, UK
13National Institute for Health Research Clinical Research Facility, Royal Brompton Hospital, London, UK
14Keck School of Medicine, University of Southern California, Los Angeles, California, USA
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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

This manuscript has recently been accepted for publication in the European Respiratory Journal. It is published here in its accepted form prior to copyediting and typesetting by our production team. After these production processes are complete and the authors have approved the resulting proofs, the article will move to the latest issue of the ERJ online. Please open or download the PDF to view this article.

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;.

This is a PDF-only article. Please click on the PDF link above to read it.

  • Received May 1, 2020.
  • Accepted December 9, 2020.
  • Copyright ©ERS 2021
http://creativecommons.org/licenses/by/4.0/

This version is distributed under the terms of the Creative Commons Attribution Licence 4.0.

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Home spirometry in patients with idiopathic pulmonary fibrosis: data from the INMARK trial
Imre Noth, Vincent Cottin, Nazia Chaudhuri, Tamera J Corte, Kerri A Johannson, Marlies Wijsenbeek, Stephane Jouneau, Andreas Michael, Manuel Quaresma, Klaus B Rohr, Anne-Marie Russell, Susanne Stowasser, Toby M Maher
European Respiratory Journal Jan 2021, 2001518; DOI: 10.1183/13993003.01518-2020

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Home spirometry in patients with idiopathic pulmonary fibrosis: data from the INMARK trial
Imre Noth, Vincent Cottin, Nazia Chaudhuri, Tamera J Corte, Kerri A Johannson, Marlies Wijsenbeek, Stephane Jouneau, Andreas Michael, Manuel Quaresma, Klaus B Rohr, Anne-Marie Russell, Susanne Stowasser, Toby M Maher
European Respiratory Journal Jan 2021, 2001518; DOI: 10.1183/13993003.01518-2020
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