Exacerbation recovery patterns in newly diagnosed or maintenance treatment-naïve patients with COPD: secondary analyses of TICARI 1 trial data
David M Mannino,1 Emmanuelle M Clerisme-Beaty,2 Joanne Franceschina,2 Naitee Ting,2 Nancy K Leidy3 1Department of Preventive Medicine and Environmental Health, University of Kentucky College of Public Health, Lexington, KY, USA; 2Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT, USA; 3Evi...
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| Format: | Article |
| Language: | English |
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Dove Medical Press
2018-05-01
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| Series: | International Journal of COPD |
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| Online Access: | https://www.dovepress.com/exacerbation-recovery-patterns-in-newly-diagnosed-or-maintenance-treat-peer-reviewed-article-COPD |
| _version_ | 1811263114412294144 |
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| author | Mannino DM Clerisme-Beaty EM Franceschina J Ting N Leidy NK |
| author_facet | Mannino DM Clerisme-Beaty EM Franceschina J Ting N Leidy NK |
| author_sort | Mannino DM |
| collection | DOAJ |
| description | David M Mannino,1 Emmanuelle M Clerisme-Beaty,2 Joanne Franceschina,2 Naitee Ting,2 Nancy K Leidy3 1Department of Preventive Medicine and Environmental Health, University of Kentucky College of Public Health, Lexington, KY, USA; 2Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT, USA; 3Evidera, Bethesda, MD, USA Background: Little is known about the recovery patterns from acute exacerbations of chronic obstructive pulmonary disease (AECOPD) in newly diagnosed or maintenance treatment-naïve patients with COPD. This study describes the course of AECOPD in these patients at the time of treatment for the symptoms of acute respiratory tract infection (RTI). Methods: This study was a secondary analysis of data from a 12-week, randomized clinical trial (TICARI 1) testing the efficacy and safety of once-daily tiotropium 18 µg maintenance therapy versus placebo in newly diagnosed or maintenance treatment-naïve COPD patients with acute RTI symptoms for ≤7 days. Patients received standard care for AECOPD and RTI. Due to under-recruitment, the trial ended early and hence was underpowered to detect treatment differences. Data were pooled and exacerbation recovery patterns examined by using the EXAcerbation of Chronic Pulmonary Disease Tool (EXACT), forced expiratory volume in 1 second, rescue medication use, COPD Assessment Test™, Functional Assessment of Chronic Illness Therapy–Short Form, and Work Productivity and Activity Impairment Questionnaire: Respiratory Symptoms. Results: Of 140 patients, 73.6% had a prior COPD diagnosis without maintenance therapy; 80.0% had moderate-to-severe airflow obstruction. In addition to study drug, 40.0% were prescribed pharmacologic therapy (corticosteroids [34.3%], antibiotics [16.4%], and short-acting β2-adrenergic agonists [5.0%]) within ±7 days of randomization. Over 12 weeks, 78.6% exhibited symptomatic recovery (EXACT score) in a median of 5.0 days. Across all patients, 49.3% recovered without relapse, 29.3% recovered and then relapsed, and 21.4% had persistent symptoms (recovery criteria unmet). Conclusion: A substantial portion of newly diagnosed or maintenance treatment-naïve patients with COPD experience relapse or persistent symptoms following a clinic visit for AECOPD with symptoms of RTI. Whether initiating maintenance therapy could improve outcomes and reduce exacerbation risk requires further study. Keywords: acute respiratory tract infection symptoms, acute exacerbation of chronic obstructive pulmonary disease, AECOPD, COPD Assessment Test™, EXACT, maintenance therapy, pulmonary function, tiotropium |
| first_indexed | 2024-04-12T19:38:52Z |
| format | Article |
| id | doaj.art-84d00abeaecd42b787966e44a523d98e |
| institution | Directory Open Access Journal |
| issn | 1178-2005 |
| language | English |
| last_indexed | 2024-04-12T19:38:52Z |
| publishDate | 2018-05-01 |
| publisher | Dove Medical Press |
| record_format | Article |
| series | International Journal of COPD |
| spelling | doaj.art-84d00abeaecd42b787966e44a523d98e2022-12-22T03:19:08ZengDove Medical PressInternational Journal of COPD1178-20052018-05-01Volume 131515152538244Exacerbation recovery patterns in newly diagnosed or maintenance treatment-naïve patients with COPD: secondary analyses of TICARI 1 trial dataMannino DMClerisme-Beaty EMFranceschina JTing NLeidy NKDavid M Mannino,1 Emmanuelle M Clerisme-Beaty,2 Joanne Franceschina,2 Naitee Ting,2 Nancy K Leidy3 1Department of Preventive Medicine and Environmental Health, University of Kentucky College of Public Health, Lexington, KY, USA; 2Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT, USA; 3Evidera, Bethesda, MD, USA Background: Little is known about the recovery patterns from acute exacerbations of chronic obstructive pulmonary disease (AECOPD) in newly diagnosed or maintenance treatment-naïve patients with COPD. This study describes the course of AECOPD in these patients at the time of treatment for the symptoms of acute respiratory tract infection (RTI). Methods: This study was a secondary analysis of data from a 12-week, randomized clinical trial (TICARI 1) testing the efficacy and safety of once-daily tiotropium 18 µg maintenance therapy versus placebo in newly diagnosed or maintenance treatment-naïve COPD patients with acute RTI symptoms for ≤7 days. Patients received standard care for AECOPD and RTI. Due to under-recruitment, the trial ended early and hence was underpowered to detect treatment differences. Data were pooled and exacerbation recovery patterns examined by using the EXAcerbation of Chronic Pulmonary Disease Tool (EXACT), forced expiratory volume in 1 second, rescue medication use, COPD Assessment Test™, Functional Assessment of Chronic Illness Therapy–Short Form, and Work Productivity and Activity Impairment Questionnaire: Respiratory Symptoms. Results: Of 140 patients, 73.6% had a prior COPD diagnosis without maintenance therapy; 80.0% had moderate-to-severe airflow obstruction. In addition to study drug, 40.0% were prescribed pharmacologic therapy (corticosteroids [34.3%], antibiotics [16.4%], and short-acting β2-adrenergic agonists [5.0%]) within ±7 days of randomization. Over 12 weeks, 78.6% exhibited symptomatic recovery (EXACT score) in a median of 5.0 days. Across all patients, 49.3% recovered without relapse, 29.3% recovered and then relapsed, and 21.4% had persistent symptoms (recovery criteria unmet). Conclusion: A substantial portion of newly diagnosed or maintenance treatment-naïve patients with COPD experience relapse or persistent symptoms following a clinic visit for AECOPD with symptoms of RTI. Whether initiating maintenance therapy could improve outcomes and reduce exacerbation risk requires further study. Keywords: acute respiratory tract infection symptoms, acute exacerbation of chronic obstructive pulmonary disease, AECOPD, COPD Assessment Test™, EXACT, maintenance therapy, pulmonary function, tiotropiumhttps://www.dovepress.com/exacerbation-recovery-patterns-in-newly-diagnosed-or-maintenance-treat-peer-reviewed-article-COPDacute respiratory tract infection symptomsacute exacerbation of chronic obstructive pulmonary disease (AECOPD)COPD Assessment Test™EXACTmaintenance therapypulmonary functiontiotropium |
| spellingShingle | Mannino DM Clerisme-Beaty EM Franceschina J Ting N Leidy NK Exacerbation recovery patterns in newly diagnosed or maintenance treatment-naïve patients with COPD: secondary analyses of TICARI 1 trial data International Journal of COPD acute respiratory tract infection symptoms acute exacerbation of chronic obstructive pulmonary disease (AECOPD) COPD Assessment Test™ EXACT maintenance therapy pulmonary function tiotropium |
| title | Exacerbation recovery patterns in newly diagnosed or maintenance treatment-naïve patients with COPD: secondary analyses of TICARI 1 trial data |
| title_full | Exacerbation recovery patterns in newly diagnosed or maintenance treatment-naïve patients with COPD: secondary analyses of TICARI 1 trial data |
| title_fullStr | Exacerbation recovery patterns in newly diagnosed or maintenance treatment-naïve patients with COPD: secondary analyses of TICARI 1 trial data |
| title_full_unstemmed | Exacerbation recovery patterns in newly diagnosed or maintenance treatment-naïve patients with COPD: secondary analyses of TICARI 1 trial data |
| title_short | Exacerbation recovery patterns in newly diagnosed or maintenance treatment-naïve patients with COPD: secondary analyses of TICARI 1 trial data |
| title_sort | exacerbation recovery patterns in newly diagnosed or maintenance treatment na iuml ve patients with copd secondary analyses of ticari 1 trial data |
| topic | acute respiratory tract infection symptoms acute exacerbation of chronic obstructive pulmonary disease (AECOPD) COPD Assessment Test™ EXACT maintenance therapy pulmonary function tiotropium |
| url | https://www.dovepress.com/exacerbation-recovery-patterns-in-newly-diagnosed-or-maintenance-treat-peer-reviewed-article-COPD |
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