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ERJ Open Res. 2019 Feb 25;5(1). pii: 00243-2018. doi: 10.1183/23120541.00243-2018. eCollection 2019 Feb.

Treatment response in COPD: does FEV1 say it all? A post hoc analysis of the CRYSTAL study.

Author information

1
Respiratory Medicine Dept, University of Ioannina, Ioannina, Greece.
2
Dept of Medicine, Pulmonary and Critical Care Medicine, University Medical Center Giessen and Marburg, Philipps-Universität Marburg, Member of the German Center for Lung Research (DZL), Giessen, Germany.
3
Airways Disease Section, National Heart and Lung Institute, Imperial College London, London, UK.
4
Novartis Pharma GmbH, Nuremberg, Germany.
5
Novartis Pharma AG, Basel, Switzerland.
6
TFS Develop, Barcelona, Spain.
7
Dept of Cardiology and Angiology I, Heart Center Freiburg University, Faculty of Medicine, University of Freiburg, Freiburg, Germany.
8
These two authors contributed equally to this work.

Abstract

The association between clinically relevant changes in patient-reported outcomes (PROs) and forced expiratory volume in 1 s (FEV1) in patients with chronic obstructive pulmonary disease (COPD) has rarely been investigated. Using CRYSTAL, a 12-week open-label study in symptomatic, nonfrequently exacerbating patients with moderate COPD, we assessed at baseline the correlations between several PROs (Baseline Dyspnoea Index, modified Medical Research Council dyspnoea scale, COPD Assessment Test (CAT) and Clinical COPD Questionnaire (CCQ)), and between FEV1 and PROs. Associations between clinically relevant responses in FEV1, CAT, CCQ and Transition Dyspnoea Index (TDI) at week 12 were also assessed. Using data from 4324 patients, a strong correlation was observed between CAT and CCQ (rs=0.793) at baseline, with moderate or weak correlations between other PROs, and no correlation between FEV1 and any PRO. At week 12, 2774 (64.2%) patients were responders regarding TDI, CAT or CCQ, with 583 (13.5%) responding using all three measures. In comparison, 3235 (74.8%) were responders regarding FEV1, TDI, CAT or CCQ, with 307 (7.1%) responding concerning all four parameters. Increases in lung function were accompanied by clinically relevant improvements of PROs in a minority of patients. Our results also suggest that PROs are not interchangeable. Thus, the observed treatment success in a clinical trial may depend on the selected parameters.

Conflict of interest statement

Conflict of interest: K. Kostikas was an employee of Novartis until October 31, 2018. Conflict of interest: T. Greulich reports receiving support from Novartis for participation as a centre in the current the study; and personal fees for lectures and advisory boards from AstraZeneca, Berlin-Chemie, Boehringer Ingelheim, Chiesi, CSL Behring, GSK and Novartis, grants and personal fees for lectures and advisory boards from Grifols, and grants from the German Centre for Lung Research (DZL), Marburg, Germany, outside the submitted work. Conflict of interest: A.J. Mackay was a European Respiratory Society Fellow in Industry at Novartis during the preparation of the manuscript. He is a current employee of AstraZeneca and has received speaker fees from Pfizer outside the submitted work. Conflict of interest: N.S. Lossi is currently an employee of Novartis Pharma GmbH. Conflict of interest: M. Aalamian-Mattheis is an employee of Novartis Pharma AG. Conflict of interest: X. Nunez analysed the data in the present study as a statistician employed by TFS. Conflict of interest: V.A. Pagano analysed the data in the present study as a statistician employed by TFS. Conflict of interest: F. Patalano is an employee and a shareholder of Novartis Pharma AG. Conflict of interest: A. Clemens is a full-time employee and shareholder at Novartis Pharma AG. Conflict of interest: C.F. Vogelmeier reports personal fees from Almirall, Cipla, Berlin-Chemie/Menarini, CSL Behring and Teva, grants and personal fees from AstraZeneca, Ingelheim, Chiesi, GSK, Grifols, Mundipharma, Novartis and Takeda, grants from German Federal Ministry of Education and Research (BMBF) Competence Network Asthma and COPD (ASCONET), Bayer Schering Pharma AG, MSD and Pfizer, outside the submitted work.

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