24-Hour Serial Spirometric Assessment of Once-Daily Fluticasone Furoate/Umeclidinium/Vilanterol Versus Twice-Daily Budes
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ORIGINAL RESEARCH
24-Hour Serial Spirometric Assessment of Once-Daily Fluticasone Furoate/Umeclidinium/Vilanterol Versus Twice-Daily Budesonide/Formoterol in Patients with COPD: Analysis of the FULFIL Study David A. Lipson . Ruby Birk . Noushin Brealey . Chang-Qing Zhu
Received: July 7, 2020 / Accepted: September 3, 2020 Ó The Author(s) 2020
ABSTRACT Introduction: Few studies have utilized 24-h serial spirometry to compare the effects of inhaled chronic obstructive pulmonary disease (COPD) therapies on lung function. The FULFIL study previously reported significant lung function improvements with once-daily singleinhaler fluticasone furoate/umeclidinium/ vilanterol (FF/UMEC/VI) versus twice-daily single-inhaler budesonide/formoterol (BUD/FOR) in patients with symptomatic COPD at risk of exacerbations. Methods: This prespecified analysis evaluated 24-h serial spirometry data from a subgroup of 406 patients in FULFIL. BUD/FOR twice-daily dosing was maintained during 24-h spirometry. A post hoc analysis evaluated serial forced expiratory volume in 1 s (FEV1) at day 1 and
D. A. Lipson (&) GSK, 1250 S Collegeville Rd, Collegeville, PA 19426, USA e-mail: [email protected] D. A. Lipson Perelman School of Medicine, University of Pennsylvania, 3400 Civic Center Blvd, Philadelphia, PA 19104, USA R. Birk N. Brealey C.-Q. Zhu GSK, Stockley Park West, Iron Bridge Rd N, West Drayton, Uxbridge UB11 1BT, UK
week 24 by disease severity at screening (FEV1 \ 50% predicted and no moderate or severe exacerbation in prior year, FEV1 \ 50% predicted and C 1 moderate or severe exacerbation in prior year, and FEV1 C 50% and \ 80% predicted and C 2 moderate or C 1 severe exacerbations in prior year). Results: Odds of achieving a C 100-mL increase from baseline in FEV1 within the first 6 h post dose on day 1 were significantly greater with FF/UMEC/VI than BUD/FOR [odds ratio 2.79 (95% confidence interval 1.56–4.98); p \ 0.001]. FF/UMEC/VI led to greater improvements in weighted mean FEV1 over 0–6, 0–12, 0–24, and 12–24 h on day 1 and at week 24, with the greatest between-group differences at week 24 (range 196–210 mL; all p \ 0.001). Significant between-treatment differences in FEV1 and forced vital capacity (FVC) in favor of FF/UMEC/VI versus BUD/FOR were seen at all time points at week 24 (FEV1 range 156–231 mL, all p \ 0.001; FVC range 139–309 mL, all p B 0.002). Serial FEV1 results were consistent irrespective of disease severity at screening. Conclusion: These findings further demonstrate sustained lung function benefits with once-daily FF/UMEC/VI single-inhaler triple therapy in patients with symptomatic COPD at risk of exacerbations across a range of disease severities.
Adv Ther
Keywords: Chronic obstructive pulmonary disease; Lung function; Single-inhaler triple therapy; Long-acting b2-agonist; Long-acting muscarinic antagonist; Inhaled corticosteroid; Serial FEV1
These data further support the lung function benefits of once-daily FF/UMEC/VI single-inhaler triple therapy in symptomatic patients with COPD at risk of
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