Treatment response in COPD: does FEV1 say it all? A post hoc analysis of the CRYSTAL study
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 exace...
| Main Authors: | , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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European Respiratory Society
2019-02-01
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| Series: | ERJ Open Research |
| Online Access: | http://openres.ersjournals.com/content/5/1/00243-2018.full |
| _version_ | 1828311746697232384 |
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| author | Konstantinos Kostikas Timm Greulich Alexander J. Mackay Nadine S. Lossi Maryam Aalamian-Mattheis Xavier Nunez Veronica A. Pagano Francesco Patalano Andreas Clemens Claus F. Vogelmeier |
| author_facet | Konstantinos Kostikas Timm Greulich Alexander J. Mackay Nadine S. Lossi Maryam Aalamian-Mattheis Xavier Nunez Veronica A. Pagano Francesco Patalano Andreas Clemens Claus F. Vogelmeier |
| author_sort | Konstantinos Kostikas |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-04-13T16:05:41Z |
| format | Article |
| id | doaj.art-75c52731c0634d439a9d3d283f4146f6 |
| institution | Directory Open Access Journal |
| issn | 2312-0541 |
| language | English |
| last_indexed | 2024-04-13T16:05:41Z |
| publishDate | 2019-02-01 |
| publisher | European Respiratory Society |
| record_format | Article |
| series | ERJ Open Research |
| spelling | doaj.art-75c52731c0634d439a9d3d283f4146f62022-12-22T02:40:25ZengEuropean Respiratory SocietyERJ Open Research2312-05412019-02-015110.1183/23120541.00243-201800243-2018Treatment response in COPD: does FEV1 say it all? A post hoc analysis of the CRYSTAL studyKonstantinos Kostikas0Timm Greulich1Alexander J. Mackay2Nadine S. Lossi3Maryam Aalamian-Mattheis4Xavier Nunez5Veronica A. Pagano6Francesco Patalano7Andreas Clemens8Claus F. Vogelmeier9 Respiratory Medicine Dept, University of Ioannina, Ioannina, Greece 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 Airways Disease Section, National Heart and Lung Institute, Imperial College London, London, UK Novartis Pharma GmbH, Nuremberg, Germany Novartis Pharma AG, Basel, Switzerland TFS Develop, Barcelona, Spain TFS Develop, Barcelona, Spain Novartis Pharma AG, Basel, Switzerland Novartis Pharma AG, Basel, Switzerland 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 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.http://openres.ersjournals.com/content/5/1/00243-2018.full |
| spellingShingle | Konstantinos Kostikas Timm Greulich Alexander J. Mackay Nadine S. Lossi Maryam Aalamian-Mattheis Xavier Nunez Veronica A. Pagano Francesco Patalano Andreas Clemens Claus F. Vogelmeier Treatment response in COPD: does FEV1 say it all? A post hoc analysis of the CRYSTAL study ERJ Open Research |
| title | Treatment response in COPD: does FEV1 say it all? A post hoc analysis of the CRYSTAL study |
| title_full | Treatment response in COPD: does FEV1 say it all? A post hoc analysis of the CRYSTAL study |
| title_fullStr | Treatment response in COPD: does FEV1 say it all? A post hoc analysis of the CRYSTAL study |
| title_full_unstemmed | Treatment response in COPD: does FEV1 say it all? A post hoc analysis of the CRYSTAL study |
| title_short | Treatment response in COPD: does FEV1 say it all? A post hoc analysis of the CRYSTAL study |
| title_sort | treatment response in copd does fev1 say it all a post hoc analysis of the crystal study |
| url | http://openres.ersjournals.com/content/5/1/00243-2018.full |
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