Striving for optimal bronchodilation: focus on olodaterol

Figures & data

Table 1 Details of Phase III trials investigating efficacy and safety of olodaterol alone or combined with tiotropium

Trial	Patients (N)	Duration	Olodaterol	Control	Results
Ferguson et al^Citation27	624 and 642	48 weeks	5 μg (via Respimat^®) 10 μg (via Respimat^®)	Placebo	Olodaterol 5 and 10 μg significantly improved the FEV1 AUC0–3 and trough FEV1 response. Weekly mean daytime and nighttime rescue medication use was significantly reduced versus placebo. The incidences of adverse events were similar to those for placebo.
Koch et al^Citation28	904 and 934	48 weeks	5 μg (via Respimat^®) 10 μg (via Respimat^®)	Placebo Formoterol 12 μg TD (via Aerolizer^®)	Olodaterol significantly improved FEV1 AUC0–3 and trough FEV1 responses versus placebo. SGRQ total score was significantly improved with olodaterol versus placebo. No abnormalities in vital signs, laboratory parameters, or electrocardiogram results were observed.
ZuWallack et al^Citation29	1,132 and 1,135	12 weeks	5 μg (via Respimat^®) combined with tiotropium 18 μg (via HandiHaler^®)	Tiotropium 18 μg (via HandiHaler^®) combined with placebo	Olodaterol + tiotropium resulted in significant improvements in FEV1 AUC0–3 and trough FEV1 over tiotropium + placebo. SGRQ total scores were significantly improved with olodaterol + tiotropium than with tiotropium + placebo. The safety profile of olodaterol + tiotropium was similar to tiotropium monotherapy.
Buhl et al^Citation30	2,624 and 2,539	52 weeks	FDC tiotropium + olodaterol 2.5/5 μg FDC tiotropium + olodaterol 5/5 μg (both via Respimat^®)	Tiotropium 2.5 μg Tiotropium 5 μg Olodaterol 5 μg (all via Respimat^®)	Both FDCs significantly improved FEV1 AUC0–3 and trough FEV1 response versus the monocomponents. Statistically significant improvements in SGRQ total score versus the monocomponents were only seen for FDC 5/5 μg. Incidence of adverse events was comparable between the FDCs and the monocomponents.

Abbreviations: TD, twice daily; FDC, fixed-dose combination; SGRQ, St George’s Respiratory Questionnaire; FEV₁, forced expiratory volume in 1 second; AUC_0–3, area under the curve from 0 to 3 hours.

FergusonGTFeldmanGJHofbauerPEfficacy and safety of olodaterol once daily delivered via Respimat® in patients with GOLD 2–4 COPD: results from two replicate 48-week studiesInt J Chron Obstruct Pulmon Dis2014962964524966672

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KochAPizzichiniEHamiltonALung function efficacy and symptomatic benefit of olodaterol once daily delivered via Respimat® versus placebo and formoterol twice daily in patients with GOLD 2–4 COPD: results from two replicate 48-week studiesInt J Chron Obstruct Pulmon Dis2014969771425045258

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ZuWallackRAllenLHernandezGEfficacy and safety of combining olodaterol Respimat® and tiotropium HandiHaler® in patients with COPD: results of two randomized, double-blind, active-controlled studiesInt J Chron Obstruct Pulmon Dis201491133114425342898

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BuhlRMaltaisFAbrahamsRTiotropium and olodaterol fixed-dose combination versus mono-components in COPD (GOLD 2–4)Eur Respir J201545496997925573406

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