Dataset Information


Single-inhaler fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) triple therapy versus tiotropium monotherapy in patients with COPD.

ABSTRACT: Chronic obstructive pulmonary disease (COPD) treatment guidelines do not currently include recommendations for escalation directly from monotherapy to triple therapy. This 12-week, double-blind, double-dummy study randomized 800 symptomatic moderate-to-very-severe COPD patients receiving tiotropium (TIO) for ≥3 months to once-daily fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) 100/62.5/25 mcg via ELLIPTA (n = 400) or TIO 18 mcg via HandiHaler (n = 400) plus matched placebo. Study endpoints included change from baseline in trough forced expiratory volume in 1 s (FEV1) at Days 85 (primary), 28 and 84 (secondary), health status (St George's Respiratory Questionnaire [SGRQ] and COPD Assessment Test [CAT]) and safety. FF/UMEC/VI significantly improved trough FEV1 at all timepoints (Day 85 treatment difference [95% CI] 95 mL [62-128]; P < 0.001), and significantly improved SGRQ and CAT versus TIO. Treatment safety profiles were similar. Once-daily single-inhaler FF/UMEC/VI significantly improved lung function and health status versus once-daily TIO in symptomatic moderate-to-very-severe COPD patients, with a similar safety profile.

PROVIDER: S-EPMC8149706 | BioStudies |

REPOSITORIES: biostudies

Similar Datasets

| S-EPMC5126189 | BioStudies
| S-EPMC4875926 | BioStudies
| S-EPMC6245710 | BioStudies
| S-EPMC8181617 | BioStudies
| S-EPMC5702366 | BioStudies
| S-EPMC7444357 | BioStudies
| S-EPMC8047616 | BioStudies
| S-EPMC5778187 | BioStudies
| S-EPMC7257245 | BioStudies
| S-EPMC5934530 | BioStudies