P275 Comparing clinically relevant improvement with umeclidinium/vilanterol and tiotropium/olodaterol in symptomatic copd: a randomised non-inferiority crossover trial
Abstract
Introduction and Objectives Here we report the Results of the first direct comparison of the once-daily fixed-dose long-acting muscarinic antagonist/long-acting β2-agonist (LAMA/LABA) combinations umeclidinium/vilanterol (UMEC/VI) 62.5/25 mcg and tiotropium/olodaterol (TIO/OLO) 5/5 mcg in patients with chronic obstructive pulmonary disease (COPD). Methods This randomised, 2-period crossover study (204990, NCT02799784) included inhaled corticosteroid-free patients with COPD, a modified Medical Research Council dyspnoea score ≥2, forced expiratory volume in 1 s (FEV1)/forced vital capacity ratio of <0.70 and post-salbutamol FEV150%–70% predicted. Patients were randomised to UMEC/VI (62.5/25 mcg once daily) via an ELLIPTA dry powder inhaler followed by TIO/OLO 5/5 mcg (2 puffs once daily) via a RESPIMAT inhaler (each for 8 weeks with an interim 3 week washout period), or vice versa. The primary endpoint was change from baseline (CFB) in trough FEV1 at Week 8 with a non-inferiority (NI) margin of –50 mL in the per protocol (PP) population. Additional outcomes included inspiratory capacity (IC), rescue medication use and ease of inhaler use (assessed using a six-point questionnaire). Adverse events (AEs) were also assessed. Results 236 patients (mean age 64.4 years, 60% male) were included in the intent-to-treat (ITT) population and 227 in the PP population. The primary endpoint of CFB in trough FEV1 at Week 8 confirmed NI of UMEC/VI vs TIO/OLO (175 mL vs 122 mL; least squares…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 236 participants or records.
Read the paper
Related studies
- Characterization and Analysis of Porosity and Pore Structures
- Practical considerations for conducting ecotoxicity test methods with manufactured nanomaterials: what have we learnt so far?
- Dental Optical Coherence Tomography
- Radiation-shielding concrete: A review of materials, performance, and the impact of radiation on concrete properties
- Testing entanglement of annihilation photons
- Calanus finmarchicus seasonal cycle and diapause in relation to gene expression, physiology, and endogenous clocks
Go deeper in Evidence Hub
Evidence Hub adds a study data sheet (design, sample size, evidence level, key numbers), an AI summary and a chat grounded in the paper's text.