What is Spiolto® Respimat®
(tiotropium/olodaterol)?
The SPIOLTO® RESPIMAT® is a soft mist inhaler delivering tiotropium + olodaterol inhalation solution.1
SPIOLTO® RESPIMAT® is indicated for the long term, once-daily maintenance treatment in patients with COPD (including chronic bronchitis and emphysema), to reduce airflow obstruction, to improve quality of life, to reduce associated dyspnoea, to improve exercise tolerance and to reduce exacerbations.1
What is the safety profile of Spiolto® Respimat®
(tiotropium/olodaterol)?
The clinical development program of SPIOLTO® RESPIMAT® encompassed more than 19000 patients with COPD, of which more than 5900 COPD patients received a dose of 5 microgram tiotropium and 5 microgram olodaterol. In the two pivotal trials (Trials 1 and 2) the overall incidence of AEs in patients treated with SPIOLTO® RESPIMAT® was comparable to patients treated with the mono compound olodaterol at a dose of 5 microgram (74% and 76.6% respectively). In the pooled analysis of all three long-term clinical trials (Trial 1, 2 and Trial 9) the overall incidence of AEs in patients treated with SPIOLTO® RESPIMAT® was comparable to patients treated with the mono components tiotropium at a dose of 5 microgram (74.1% and 74.3% respectively).1
References
1. SPIOLTO® RESPIMAT® Thailand Prescribing Information 19 December 2018