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Outcomes consequent to “early” COPD for interventional studies

Stephen I. Rennard
European Respiratory Journal 2020 55: 1902380; DOI: 10.1183/13993003.02380-2019
Stephen I. Rennard
Division of Pulmonary, Critical Care, Allergy and Sleep Medicine, Dept of Internal Medicine, University of Nebraska Medical Center, Omaha, NE, USA
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Abstract

Data presented in the recent study by Çolak and co-workers permit estimates of trials to alter natural history of COPD using endpoints other than FEV1 http://bit.ly/2sIxMSB

To the Editor:

The recent paper by Çolak et al. [1] and colleagues adds to the growing body of information relating to early COPD. The study confirms the importance of symptoms among individuals prior to meeting the arbitrary threshold of forced expiratory volume in 1 s (FEV1) to forced vital capacity ratio <0.7, and that these individuals are at risk for serious morbidity and mortality. Importantly, this is demonstrated in a population-based sample. The authors clearly address the difficulty in distinguishing “early” from “mild” COPD, but have included younger individuals, which suggests that “early” disease is present in many. Recognition of this group at serious risk for subsequent events invites consideration of interventions designed to alter the disease course. To date, attempts to alter natural history of COPD have been powered on changes in airflow assessed by FEV1. Alternative outcomes could be very useful: could Çolak and colleagues estimate the sample sizes for interventional studies designed to alter the course of COPD using the outcomes they assessed?

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Footnotes

  • Conflict of interest: S.I. Rennard was an employee of AstraZeneca until 30 November, 2019 and holds shares in the company; and has received funding from the tobacco industry for studies relating to harm reduction and to the impact of tobacco smoke on stem cells; he also consulted with RJ Reynolds without personal fee on the topic of harm reduction; he received funding from RJ Reynolds to evaluate the effect of a harm reduction product in normal smokers (1996) and in subjects with chronic bronchitis (1999) and to assess the effect of smoking cessation on lower respiratory tract inflammation (2000); he participated in a Philip Morris multicentre study to assess biomarkers of smoke exposure (2002); he received funding for a clinical trial from the Institute for Science and Health (2005), which receives support from the tobacco industry, to evaluate biomarkers in exhaled breath associated with smoking cessation and reduction; this study was supplemented with funding from Lorillard and RJ Reynolds; he received a grant from the Philip Morris External Research Program (2005) to assess the impact of cigarette smoking on circulating stem cells in the mouse; he consulted with RJ Reynolds on the topic of harm reduction until 2007, but did not receive personal remuneration for this. There are no active tobacco-industry funded projects. All ties with tobacco industry companies and entities supported by tobacco companies were terminated in 2007.

  • Received December 11, 2019.
  • Accepted December 15, 2019.
  • Copyright ©ERS 2020
https://www.ersjournals.com/user-licence

Reference

  1. ↵
    1. Çolak Y,
    2. Nordestgaard BG,
    3. Vestbo J, et al.
    Prognostic significance of chronic respiratory symptoms in individuals with normal spirometry. Eur Respir J 2019; 54: 1900734doi:10.1183/13993003.00734-2019.
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Outcomes consequent to “early” COPD for interventional studies
Stephen I. Rennard
European Respiratory Journal Mar 2020, 55 (3) 1902380; DOI: 10.1183/13993003.02380-2019

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Outcomes consequent to “early” COPD for interventional studies
Stephen I. Rennard
European Respiratory Journal Mar 2020, 55 (3) 1902380; DOI: 10.1183/13993003.02380-2019
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