Trial of Stiolto Respimat (tiotropium/olodaterol) in COPD meets all endpoints- Boehringer Ingelheim

Boehringer Ingelheim has announced new data that show increase in FEV1 AUC_0–12, a measure of lung function, with Stiolto Respimat (tiotropium/olodaterol, approved in the EU as Spiolto Respimat) compared to a European formulation of a combination of long-acting beta agonist (LABA), salmeterol, and inhaled corticosteroid (ICS), fluticasone propionate (50/500 µg, 50/250 µg). The study was conducted in patients with moderate to severe chronic obstructive pulmonary disease (COPD).

In the six week ENERGITO randomised, double-blind, double-dummy, active-controlled, four-treatment, four-period, complete crossover study (NCT01969721), once daily Stiolto Respimat met all lung function endpoints (FEV1 AUC_0–12, the primary endpoint; FEV1 AUC_0–24, FEV1 AUC_12–24 and trough FEV1, the secondary endpoints, which were descriptive only). In addition, FEV1 AUC_0-12 was increased with once daily Stiolto Respimat after six weeks compared to two doses of twice daily LABA/ICS salmeterol/fluticasone propionate (50/500 µg: 129 mL; 50/250 µg: 125 mL). Finally, in the OTEMTO 1&2 post-hoc analysis (NCT01964352 / NCT02006732), SGRQ total scores were lower (which means an improvement in score), with Stiolto Respimat compared to placebo or tiotropium alone in COPD patients with GOLD stage 2 disease.

The frequency of adverse events (AEs) was similar between all treatment groups. These data – from the ENERGITO study – were presented at the annual European Respiratory Society (ERS) International Congress.

Comment: Stiolto Respimat is the fourth Respimat inhaled drug that the FDA has approved for market for chronic obstructive pulmonary disease. It is a once-a-day treatment that improves lung function in five minutes and reduces patients’ dependence on rescue inhalers. In clinical trials of more than 5,000 patients with differing severities of COPD, Stiolto Respimat was able to provide greater improvements in lung function than Spiriva Respimat (tiotropium bromide) or Striverdi Respimat (olodaterol) alone. Spiriva Respimat was launched in the US in January 2015, following FDA approval in September 2014. Striverdi Respimat was approved a month earlier, while the older Combivent Respimat (ipratropium bromide & albuterol) gained approval in 2011.