Rationale To evaluate the effect of single-inhaler extrafine BDP/FF/GB pMDI vs two-inhaler (FLF/VIL+TIO) triple therapies on HRQoL in patients with COPD to support market access dossiers in Europe.
Methods In this phase III, multicenter, randomized study patients received BDP/FF/GB 100/6/12.5 µg extrafine pMDI 2 inhalations BID or FLF/VIL 100/25 µg 1 inhalation QD + TIO 18 µg/d 1 inhalation QD for 26 weeks. The primary efficacy variable was the change from baseline in the St. George Respiratory Questionnaire (SGRQ) total score at Wk 26 in the intent-to-treat (ITT) and per-protocol (PP) populations, with non-inferiority defined as an upper confidence limit of the adjusted mean difference between treatments <4 units. Secondary endpoints included SGRQ response (defined as a decrease of ≥4 units in total score), change in pre-dose FEV1 at Wk 26, and rate of moderate-to-severe COPD exacerbations over 26 weeks.
Results A total of 1157 patients were randomized (1095 completed), of whom 53.5% were <65 years of age, 75.5% males, 54.4% current smokers and 84.1% had 1 exacerbation in the past year. Baseline SGRQ total score was 52.8. In both groups the adjusted mean change from baseline in the SGRQ total score significantly decreased at Wk 26, with -6.77 for BDP/FF/GB and -7.82 for FLF/VIL+TIO in the ITT population. Non-inferiority was demonstrated in both ITT and PP populations, with an upper confidence interval of the adjusted mean difference below 4. SGRQ response rates at Week 26 were similar (51.1% and 53.0%) and pre-dose FEV1 mean changes from baseline were 59 and 105 mL (p<0.001). Adjusted rate ratio was 1.086 (p=0.525) for moderate-to-severe exacerbations and 0.568 for severe exacerbations (p=0.068). Serious TEAEs occurred in 39 (6.7%) and 56 (9.7%) in each group, respectively.
Conclusion Treatment with BDP/FF/GB extrafine pMDI for 26 weeks significantly improved HRQoL as measured by the SGRQ and was non-inferior compared to FLF/VIL+TIO. Lung function improved with both treatments but more so with FLF/VIL+TIO whereas a larger reduction in severe exacerbations occurred with extrafine BDP/FF/GB. Both treatments were safe and well tolerated.
Please refer to page A188 for declarations of interest related to this abstract.
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