SPIOLTO® RESPIMAT®
Efficacy
In two replicate, randomized, double-blind, parallel-group, multicenter, phase III trials, TONADO 1 and 2, tiotropium + olodaterol 2.5/5 μg or 5/5 μg, tiotropium 2.5 μg or 5 μg, or olodaterol 5 μg delivered once-daily via RESPIMAT® were compared over 52 weeks. Primary end points were FEV1 AUC0–3h response, trough FEV1 response and SGRQ total score at 24 weeks.1
SPIOLTO® RESPIMAT® significantly improved lung function vs. either mono-component in moderate to severe COPD patients1
In both studies, significant improvements were observed in FEV1 AUC0-3h response and trough FEV1 response after 24 weeks for SPIOLTO® RESPIMAT® compared to tiotropium 5 μg and olodaterol 5 μg.1
SPIOLTO® RESPIMAT® significantly improved health-related quality of life vs. either mono-component in moderate to severe COPD patients1
SPIOLTO® RESPIMAT® showed improvement in health-related quality of life as indicated by a reduction in SGRQ total score. After 24 weeks, there was a statistically significant improvement in mean SGRQ total score for SPIOLTO® RESPIMAT® compared to tiotropium 5 μg and olodaterol 5 μg.1
SPIOLTO® RESPIMAT® improves breathlessness vs. either mono-component in moderate to severe COPD patients2
After 24 weeks, mean TDI focal score was 1.98 units for SPIOLTO® RESPIMAT®, with a significant improvement compared to tiotropium 5 μg (mean difference 0.36, p=0.008) and olodaterol 5 μg (mean difference 0.42, p=0.002).2
SPIOLTO® RESPIMAT® improves exercise endurance time vs. SPIRIVA® RESPIMAT®3
In a 12-week, randomized, partially double-blind, placebo-controlled, parallel-group trial in COPD patients, PHYSACTO, the effect of SPIOLTO® RESPIMAT® on exercise endurance time (with or without ExT) was evaluated. All patients were enrolled into SMBM and randomized 1:1:1:1 to once-daily placebo, SPIRIVA® RESPIMAT®, SPIOLTO® RESPIMAT®, or SPIOLTO® RESPIMAT® plus 8 weeks ExT.3
At 8 weeks, there was a 46% improvement in exercise endurance time with SPIOLTO® RESPIMAT® + SMBM and ExT vs placebo + SMBM (p=0.0002). SPIOLTO® RESPIMAT® + SMBM also demonstrated a 29% improvement in exercise endurance time vs placebo + SMBM at 8 weeks (P=0.0109).3
SPIOLTO® RESPIMAT® was associated with a lower rate of moderate to severe COPD exacerbations compared to SPIRIVA® RESPIMAT® over 52 weeks4
DYNAGITO® was a one-year exacerbation trial with 7,880 patients. The primary endpoint of the study was designed to assess the annualized rate of moderate to severe COPD exacerbations over 52 weeks, with SPIOLTO® RESPIMAT® vs. SPIRIVA® RESPIMAT® with a significance level of 1% (p ≤0.01). This was not met.5
In the prespecified analysis of 461 Japanese patients in DYNAGITO, the annualized rate of moderate-to-severe COPD exacerbation was 29% lower in SPIOLTO® RESPIMAT® vs. SPIRIVA® RESPIMAT® (RR 0.71, p=0.0434) and the annualized rate of severe exacerbation was 19% lower in SPIOLTO® RESPIMAT® vs. SPIRIVA® RESPIMAT® (RR 0.81, p=0.3924).6
In the post-hoc analysis of the pooled data from TONADO and DYNAGITO trials, the exacerbation rates were investigated in 4,968 patients who received SPIOLTO® RESPIMAT® vs. 4,974 patients who received SPIRIVA® RESPIMAT®. SPIOLTO® RESPIMAT® was associated with a lower rate of moderate/severe exacerbations compared with SPIRIVA® RESPIMAT®, regardless of exacerbation history.4
Footnote:
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AUC0–3h, area under the curve 0–3 hours; CI, confidence interval; ExT, exercise training; FEV1, forced expiratory volume in one second; RR, relative risk; SGRQ, St George's Respiratory Questionnaire; SMBM, self-management behavior-modification program; TDI, Mahler Transition Dyspnea Index
References:
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Buhl R et al. Eur Respir J 2015;45:969–79.
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SPIOLTO® RESPIMAT® Summary of Product Characteristics.
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Troosters T et al. Am J Respir Crit Care Med. 2018;198(8):1021–32 and supplementary material.
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Wedzicha JA, et al. Adv Ther. 2020 Oct;37(10):4266-4279.
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Calverley P et al. Lancet Respir Med. 2018;6:337–44.
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Ichinose M, et al. Int J Chron Obstruct Pulmon Dis. 2018 Jul 13;13:2147-2156.
