دورية أكاديمية
Functional respiratory imaging assessment of budesonide/glycopyrrolate/formoterol fumarate and glycopyrrolate/formoterol fumarate metered dose inhalers in patients with COPD : the value of inhaled corticosteroids
| العنوان: | Functional respiratory imaging assessment of budesonide/glycopyrrolate/formoterol fumarate and glycopyrrolate/formoterol fumarate metered dose inhalers in patients with COPD : the value of inhaled corticosteroids |
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| المؤلفون: | van den Berge, Maarten, De Backer, Jan, van Holsbeke, Cedric, De Backer, Wilfried A.K., Trivedi, Roopa, Jenkins, Martin, Dorinsky, Paul, Aurivillius, Magnus |
| المصدر: | 1465-9921 ; Respiratory research |
| سنة النشر: | 2021 |
| المجموعة: | IRUA - Institutional Repository van de Universiteit Antwerpen |
| مصطلحات موضوعية: | Human medicine |
| الوصف: | Background: For patients with chronic obstructive pulmonary disease (COPD), greater improvements in lung function have been demonstrated for triple versus dual inhaled therapies in traditional spirometry studies. This study was the first to use functional respiratory imaging (FRI), known for increased sensitivity to airway changes versus spirometry, to assess the effect of the inhaled corticosteroid (ICS) component (budesonide) on lung function in patients with moderate-to-severe COPD and a blood eosinophil count > 150 cells/mm(3). Methods: Patients in this Phase IIIb (NCT03836677), randomized, double-blind, crossover study received twice-daily budesonide/glycopyrrolate/formoterol fumarate (BGF) 320/18/9.6 mu g fixed-dose triple therapy and glycopyrrolate/formoterol fumarate (GFF) 18/9.6 mu g fixed-dose dual therapy over 4 weeks, each delivered via a single metered dose Aerosphere inhaler. Primary endpoints were the improvements from baseline for each treatment in specific (i.e. corrected for lobar volume) image-based airway volume (siVaw) and resistance (siRaw) measured via FRI taken at total lung capacity (Day 29). Secondary outcomes included spirometry and body plethysmography. Adverse events were monitored throughout the study. Results: A total of 23 patients were randomized and included in the intent-to-treat analysis (mean age 64.9 years, 78.3% males, 43.5% current smokers, mean predicted post-bronchodilator forced expiratory volume in 1 s [FEV1] 63.6%). BGF and GFF both statistically significantly increased siVaw from baseline at Day 29 (geometric mean ratio [GM], 95% confidence interval [CI]: 1.72 [1.38, 2.13] and 1.53 [1.28, 1.83], respectively, both p < 0.0001), with a greater increase observed for BGF versus GFF (GM, 95% CI 1.09 [1.03, 1.16], p = 0.0061). Statistically significant reductions in siRaw were also observed with both BGF and GFF (GM, 95% CI 0.50 [0.39, 0.63] and 0.52 [0.40, 0.67], respectively, both p < 0.0001). Additionally, significant improvements from baseline in ... |
| نوع الوثيقة: | article in journal/newspaper |
| اللغة: | English |
| العلاقة: | info:eu-repo/semantics/altIdentifier/isi/000671816600002 |
| الإتاحة: | https://doi.org/10.1186/S12931-021-01772-2Test https://hdl.handle.net/10067/1797760151162165141Test https://repository.uantwerpen.be/docstore/d:irua:7455Test |
| حقوق: | info:eu-repo/semantics/openAccess |
| رقم الانضمام: | edsbas.FF368450 |
| قاعدة البيانات: | BASE |
| الوصف غير متاح. |