Umeclidinium/vilanterol as step-up therapy from tiotropium in patients with moderate COPD: a randomized, parallel-group, 12-week study
| Autor: | Edward Kerwin, Dmitry V Galkin, John H. Riley, Chang-Qing Zhu, Chris Kalberg, Alison Church, William A. Fahy |
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| Rok vydání: | 2017 |
| Předmět: |
Male
Quinuclidines Time Factors Vital Capacity Pulmonary Disease Chronic Obstructive South Africa chemistry.chemical_compound 0302 clinical medicine tiotropium Forced Expiratory Volume Surveys and Questionnaires Bronchodilator Clinical endpoint 030212 general & internal medicine Lung Original Research step-up COPD Drug Substitution LAMA General Medicine Tiotropium bromide Middle Aged Bronchodilator Agents Intention to Treat Analysis Europe Treatment Outcome Anesthesia Female Vilanterol medicine.drug medicine.drug_class Argentina LABA Muscarinic Antagonists Chlorobenzenes 03 medical and health sciences umeclidinium/vilanterol medicine Humans Least-Squares Analysis Tiotropium Bromide Adverse effect Benzyl Alcohols Aged Intention-to-treat analysis business.industry technology industry and agriculture Recovery of Function medicine.disease United States Confidence interval Logistic Models 030228 respiratory system chemistry business |
| Zdroj: | International Journal of Chronic Obstructive Pulmonary Disease |
| ISSN: | 1178-2005 |
| DOI: | 10.2147/copd.s119032 |
| Popis: | Introduction Patients with COPD who remain symptomatic on long-acting bronchodilator monotherapy may benefit from step-up therapy to a long-acting bronchodilator combination. This study evaluated the efficacy and safety of umeclidinium (UMEC)/vilanterol (VI) in patients with moderate COPD who remained symptomatic on tiotropium (TIO). Methods In this randomized, blinded, double-dummy, parallel-group study (NCT01899742), patients (N=494) who were prescribed TIO for ≥3 months at screening (forced expiratory volume in 1 s [FEV1]: 50%–70% of predicted; modified Medical Research Council [mMRC] score ≥1) and completed a 4-week run-in with TIO were randomized to UMEC/VI 62.5/25 µg or TIO 18 µg for 12 weeks. Efficacy assessments included trough FEV1 at Day 85 (primary end point), 0–3 h serial FEV1, rescue medication use, Transition Dyspnea Index (TDI), St George’s Respiratory Questionnaire (SGRQ), and COPD Assessment Test (CAT). Safety evaluations included adverse events (AEs). Results Compared with TIO, UMEC/VI produced greater improvements in trough FEV1 (least squares [LS] mean difference: 88 mL at Day 85 [95% confidence interval {CI}: 45–131]; P |
| Databáze: | OpenAIRE |
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