Blood Eosinophils in Chinese COPD Participants and Response to Treatment with Combination Low-Dose Theophylline and Prednisone: A Post-Hoc Analysis of the TASCS Trial
Thomas Bradbury,1 Gian Luca Di Tanna,1 Anish Scaria,1 Allison Martin,1 Fu-Qiang Wen,2 Nan-Shan Zhong,3 Jin-Ping Zheng,3 Peter J Barnes,4 Bartolome Celli,5 Norbert Berend,1 Christine R Jenkins1 On behalf of the TASCS Investigators1Respiratory Group, The George Institute for Global Health, Sydney, NSW...
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| Format: | Article |
| Language: | English |
| Published: |
Dove Medical Press
2022-02-01
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| Series: | International Journal of COPD |
| Subjects: | |
| Online Access: | https://www.dovepress.com/blood-eosinophils-in-chinese-copd-participants-and-response-to-treatme-peer-reviewed-fulltext-article-COPD |
| _version_ | 1818284945890607104 |
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| author | Bradbury T Di Tanna GL Scaria A Martin A Wen FQ Zhong NS Zheng JP Barnes PJ Celli B Berend N Jenkins CR |
| author_facet | Bradbury T Di Tanna GL Scaria A Martin A Wen FQ Zhong NS Zheng JP Barnes PJ Celli B Berend N Jenkins CR |
| author_sort | Bradbury T |
| collection | DOAJ |
| description | Thomas Bradbury,1 Gian Luca Di Tanna,1 Anish Scaria,1 Allison Martin,1 Fu-Qiang Wen,2 Nan-Shan Zhong,3 Jin-Ping Zheng,3 Peter J Barnes,4 Bartolome Celli,5 Norbert Berend,1 Christine R Jenkins1 On behalf of the TASCS Investigators1Respiratory Group, The George Institute for Global Health, Sydney, NSW 2042, Australia; 2West China Hospital, Sichuan University, Chengdu, People’s Republic of China; 3State Key Laboratory of Respiratory Disease, National Clinical Research Centre for Respiratory Disease, First Affiliated Hospital of Guangzhou Medical University, Guangzhou, People’s Republic of China; 4National Heart & Lung Institute, Imperial College, London, UK; 5Pulmonary and Critical Care Division, Brigham and Women’s Hospital and Harvard Medical School, Boston, MA, USACorrespondence: Thomas BradburyRespiratory Group, The George Institute for Global Health, Level 5, 1 King St, Newtown, Sydney, NSW 2042, Australia, Tel +61 2 8052 4413, Email tbradbury@georgeinstitute.org.auBackground and Objectives: The burden of chronic obstructive pulmonary disease (COPD) disproportionately affects patients in low to middle-income countries. Although the Theophylline and Steroids in COPD Study (TASCS) showed no clinical benefit from administering low-dose theophylline and prednisone in COPD patients compared to placebo, it was hypothesized that those with elevated blood eosinophil counts would receive clinical benefit from the intervention.Methods: This was a post-hoc analysis of the TASCS dataset – a double-blinded, placebo-controlled trial conducted in patients with moderate–severe COPD in China. Participants were allocated 1:1:1 to low-dose oral theophylline (100mg bd) and prednisone (5mg qd; PrT), theophylline (100mg bd) and prednisone-matched placebo (TP), or double-matched placebo (DP) groups and followed-up for 48 weeks. A baseline count of ≥ 300 eosinophils/μL blood was categorized as elevated/eosinophilic, and the primary outcome was the annualized moderate-severe exacerbation rate.Results: Of 1487 participants eligible for analysis, 325 (22%) were eosinophilic. These participants were predominantly male (82%), had a mean (SD) age of 64 (± 8) years and a predicted forced expiratory volume in 1s (FEV1) of 43% (± 16). The annualized moderate–severe exacerbation rate was significantly higher in the PrT group compared to the pooled results of the TP and DP groups (incidence rate ratio = 1.6; ([95% CI 1.06– 1.76]) p = 0.016). Changes in spirometry values and reported disease impact scores (St. George’s Respiratory Questionnaire and COPD Assessment Test) at week 48 were not significantly different between groups.Conclusion: Combination low-dose theophylline and prednisone was associated with a significant increase in the annual moderate-severe exacerbation rate in participants with a blood eosinophil count ≥ 300 cells/μL compared to placebo.Keywords: eosinophil, COPD, clinical trial, China, theophylline, prednisone |
| first_indexed | 2024-12-13T01:00:52Z |
| format | Article |
| id | doaj.art-db48cdb7d9d94db08152699791842485 |
| institution | Directory Open Access Journal |
| issn | 1178-2005 |
| language | English |
| last_indexed | 2024-12-13T01:00:52Z |
| publishDate | 2022-02-01 |
| publisher | Dove Medical Press |
| record_format | Article |
| series | International Journal of COPD |
| spelling | doaj.art-db48cdb7d9d94db081526997918424852022-12-22T00:04:41ZengDove Medical PressInternational Journal of COPD1178-20052022-02-01Volume 1727328272711Blood Eosinophils in Chinese COPD Participants and Response to Treatment with Combination Low-Dose Theophylline and Prednisone: A Post-Hoc Analysis of the TASCS TrialBradbury TDi Tanna GLScaria AMartin AWen FQZhong NSZheng JPBarnes PJCelli BBerend NJenkins CRThomas Bradbury,1 Gian Luca Di Tanna,1 Anish Scaria,1 Allison Martin,1 Fu-Qiang Wen,2 Nan-Shan Zhong,3 Jin-Ping Zheng,3 Peter J Barnes,4 Bartolome Celli,5 Norbert Berend,1 Christine R Jenkins1 On behalf of the TASCS Investigators1Respiratory Group, The George Institute for Global Health, Sydney, NSW 2042, Australia; 2West China Hospital, Sichuan University, Chengdu, People’s Republic of China; 3State Key Laboratory of Respiratory Disease, National Clinical Research Centre for Respiratory Disease, First Affiliated Hospital of Guangzhou Medical University, Guangzhou, People’s Republic of China; 4National Heart & Lung Institute, Imperial College, London, UK; 5Pulmonary and Critical Care Division, Brigham and Women’s Hospital and Harvard Medical School, Boston, MA, USACorrespondence: Thomas BradburyRespiratory Group, The George Institute for Global Health, Level 5, 1 King St, Newtown, Sydney, NSW 2042, Australia, Tel +61 2 8052 4413, Email tbradbury@georgeinstitute.org.auBackground and Objectives: The burden of chronic obstructive pulmonary disease (COPD) disproportionately affects patients in low to middle-income countries. Although the Theophylline and Steroids in COPD Study (TASCS) showed no clinical benefit from administering low-dose theophylline and prednisone in COPD patients compared to placebo, it was hypothesized that those with elevated blood eosinophil counts would receive clinical benefit from the intervention.Methods: This was a post-hoc analysis of the TASCS dataset – a double-blinded, placebo-controlled trial conducted in patients with moderate–severe COPD in China. Participants were allocated 1:1:1 to low-dose oral theophylline (100mg bd) and prednisone (5mg qd; PrT), theophylline (100mg bd) and prednisone-matched placebo (TP), or double-matched placebo (DP) groups and followed-up for 48 weeks. A baseline count of ≥ 300 eosinophils/μL blood was categorized as elevated/eosinophilic, and the primary outcome was the annualized moderate-severe exacerbation rate.Results: Of 1487 participants eligible for analysis, 325 (22%) were eosinophilic. These participants were predominantly male (82%), had a mean (SD) age of 64 (± 8) years and a predicted forced expiratory volume in 1s (FEV1) of 43% (± 16). The annualized moderate–severe exacerbation rate was significantly higher in the PrT group compared to the pooled results of the TP and DP groups (incidence rate ratio = 1.6; ([95% CI 1.06– 1.76]) p = 0.016). Changes in spirometry values and reported disease impact scores (St. George’s Respiratory Questionnaire and COPD Assessment Test) at week 48 were not significantly different between groups.Conclusion: Combination low-dose theophylline and prednisone was associated with a significant increase in the annual moderate-severe exacerbation rate in participants with a blood eosinophil count ≥ 300 cells/μL compared to placebo.Keywords: eosinophil, COPD, clinical trial, China, theophylline, prednisonehttps://www.dovepress.com/blood-eosinophils-in-chinese-copd-participants-and-response-to-treatme-peer-reviewed-fulltext-article-COPDeosinophilcopdclinical trialchinatheophyllineprednisone |
| spellingShingle | Bradbury T Di Tanna GL Scaria A Martin A Wen FQ Zhong NS Zheng JP Barnes PJ Celli B Berend N Jenkins CR Blood Eosinophils in Chinese COPD Participants and Response to Treatment with Combination Low-Dose Theophylline and Prednisone: A Post-Hoc Analysis of the TASCS Trial International Journal of COPD eosinophil copd clinical trial china theophylline prednisone |
| title | Blood Eosinophils in Chinese COPD Participants and Response to Treatment with Combination Low-Dose Theophylline and Prednisone: A Post-Hoc Analysis of the TASCS Trial |
| title_full | Blood Eosinophils in Chinese COPD Participants and Response to Treatment with Combination Low-Dose Theophylline and Prednisone: A Post-Hoc Analysis of the TASCS Trial |
| title_fullStr | Blood Eosinophils in Chinese COPD Participants and Response to Treatment with Combination Low-Dose Theophylline and Prednisone: A Post-Hoc Analysis of the TASCS Trial |
| title_full_unstemmed | Blood Eosinophils in Chinese COPD Participants and Response to Treatment with Combination Low-Dose Theophylline and Prednisone: A Post-Hoc Analysis of the TASCS Trial |
| title_short | Blood Eosinophils in Chinese COPD Participants and Response to Treatment with Combination Low-Dose Theophylline and Prednisone: A Post-Hoc Analysis of the TASCS Trial |
| title_sort | blood eosinophils in chinese copd participants and response to treatment with combination low dose theophylline and prednisone a post hoc analysis of the tascs trial |
| topic | eosinophil copd clinical trial china theophylline prednisone |
| url | https://www.dovepress.com/blood-eosinophils-in-chinese-copd-participants-and-response-to-treatme-peer-reviewed-fulltext-article-COPD |
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