Exacerbation recovery patterns in newly diagnosed or maintenance treatment-naïve patients with COPD: secondary analyses of TICARI 1 trial data
| Autor: | Nancy Kline Leidy, Naitee Ting, Emmanuelle Clerisme-Beaty, David M. Mannino, Joanne Franceschina |
|---|---|
| Jazyk: | angličtina |
| Rok vydání: | 2018 |
| Předmět: |
Male
Acute exacerbation of chronic obstructive pulmonary disease Time Factors Exacerbation Severity of Illness Index law.invention Pulmonary function testing Pulmonary Disease Chronic Obstructive 0302 clinical medicine Randomized controlled trial Maintenance therapy tiotropium law Adrenal Cortex Hormones Forced Expiratory Volume Surveys and Questionnaires 030212 general & internal medicine COPD Assessment Test™ Lung Respiratory Tract Infections Original Research Aged 80 and over COPD pulmonary function General Medicine Middle Aged Anti-Bacterial Agents Bronchodilator Agents acute respiratory tract infection symptoms Treatment Outcome Early Termination of Clinical Trials Disease Progression Drug Therapy Combination Female Adult medicine.medical_specialty Randomization maintenance therapy Work Capacity Evaluation Muscarinic Antagonists International Journal of Chronic Obstructive Pulmonary Disease acute exacerbation of chronic obstructive pulmonary disease Placebo Drug Administration Schedule 03 medical and health sciences Double-Blind Method Internal medicine EXACT Administration Inhalation medicine Humans Tiotropium Bromide Adrenergic beta-2 Receptor Agonists Aged AECOPD business.industry Recovery of Function medicine.disease United States 030228 respiratory system business |
| Zdroj: | International Journal of Chronic Obstructive Pulmonary Disease |
| ISSN: | 1178-2005 1176-9106 |
| Popis: | 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 |
| Databáze: | OpenAIRE |
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