التفاصيل البيبلوغرافية
| العنوان: |
Improvements in lung function with budesonide/glycopyrrolate/formoterol fumarate metered dose inhaler versus dual therapies in patients with COPD: a sub-study of the ETHOS trial |
| المؤلفون: |
Rabe, Klaus F., Martinez, Fernando J., Singh, Dave, Trivedi, Roopa, Jenkins, Martin, Darken, Patrick, Aurivillius, Magnus, Dorinsky, Paul |
| المساهمون: |
AstraZeneca |
| المصدر: |
Therapeutic Advances in Respiratory Disease ; volume 15, page 175346662110343 ; ISSN 1753-4666 1753-4666 |
| بيانات النشر: |
SAGE Publications |
| سنة النشر: |
2021 |
| مصطلحات موضوعية: |
Pharmacology (medical), Pulmonary and Respiratory Medicine |
| الوصف: |
Background: In the phase III, 52-week ETHOS study in patients with moderate to very severe chronic obstructive pulmonary disease (COPD), triple therapy with budesonide/glycopyrrolate/formoterol fumarate (BGF), at two inhaled corticosteroid dose levels, resulted in significantly lower moderate/severe exacerbation rates versus glycopyrrolate/formoterol fumarate (GFF) and budesonide/formoterol fumarate (BFF). Here, we report results from the ETHOS pulmonary function test (PFT) sub-study, which assessed lung function in a subset of ETHOS patients. Methods: ETHOS (NCT02465567) was a randomized, double-blind, multi-center, parallel-group study in patients with moderate to very severe COPD who had experienced ⩾1 moderate/severe exacerbation in the previous year. Patients received BGF 320/18/9.6 µg, BGF 160/18/9.6 μg, GFF 18/9.6 µg, or BFF 320/9.6 µg twice daily via a single metered dose Aerosphere inhaler for 52 weeks. A subset of patients participated in the 4-hour PFT sub-study; primary endpoints were change from baseline in morning pre-dose trough forced expiratory volume in one second (FEV 1 ) versus GFF and FEV 1 area under the curve from 0 to 4 hours (AUC 0–4 ) versus BFF at week 24. Results: The PFT modified intent-to-treat population included 3088 patients (mean age 64.4 years; mean reversibility post-albuterol 16.7%; mean post-albuterol FEV 1 % predicted 42.8). BGF 320/18/9.6 µg and 160/18/9.6 µg significantly improved morning pre-dose trough FEV 1 at week 24 versus GFF ( p ⩽ 0.0035 for both). Improvements in trough FEV 1 were also observed at week 52 for BGF 320/18/9.6 µg and 160/18/9.6 µg versus GFF ( p ⩽ 0.0005 for both). For FEV 1 AUC 0–4 at week 24, BGF 320/18/9.6 µg and 160/18/9.6 µg showed significant improvements versus BFF ( p < 0.0001 for both). Improvements were maintained at week 52 ( p < 0.0001). Conclusions: BGF 320/18/9.6 µg and 160/18/9.6 µg significantly improved trough FEV 1 versus GFF and FEV 1 AUC 0–4 versus BFF at week 24. The lung function benefits with both doses of BGF were ... |
| نوع الوثيقة: |
article in journal/newspaper |
| اللغة: |
English |
| DOI: |
10.1177/17534666211034329 |
| الإتاحة: |
https://doi.org/10.1177/17534666211034329Test |
| حقوق: |
https://creativecommons.org/licenses/by-nc/4.0Test/ |
| رقم الانضمام: |
edsbas.4BA10839 |
| قاعدة البيانات: |
BASE |
