Spiolto Respimat is indicated as a once-daily maintenance treatment to relieve symptoms in adults with moderate to severe chronic obstructive pulmonary disease (COPD). Each puff delivers 2.5 microgram tiotropium and 2.5 microgram olodaterol; the recommended dose is two puffs once daily.
Muscarinic receptors are more prominent in the central airways and β2 adrenoceptors have a higher expression level in the peripheral airways. The combination of a LAMA and a LABA thus provides additive bronchodilatation in all regions of the lungs.
Significant improvement in lung function
The efficacy and safety of the tiotropium/olodaterol combination were assessed in two 52-week, double-blind, parallel-group phase III studies comparing use of the combination with its individual components in patients with moderate to very severe COPD. All study medications were administered once daily in the morning via the Respimat inhaler.
In both studies, improvement in lung function (as assessed by FEV1 AUC0-3h and trough FEV1 responses) after 24 weeks was significantly greater in patients treated with tiotropium/olodaterol (5 microgram/5 microgram, n=522) than in those treated with tiotropium alone (Spiriva) (5 microgram, n=526) or olodaterol alone (Striverdi Respimat) (5 microgram, n=525) (p≤0.0001 for all comparisons).
More patients experienced noticeable improvements in their quality of life after 24 weeks (as indicated by a reduction in St George's Respiratory Questionnaire [SGRQ] total score) with the combination than with tiotropium or olodaterol alone (57.5% vs 48.7% [p=0.0001] or 44.8% [p<0.0001], respectively).
Patients who used the combination showed significant reductions in breathlessness (as measured by a clinically meaningful improvement in focal Transition Dyspnoea Index [TDI] score) compared with those who used tiotropium or olodaterol alone (54.9% vs 50.6% [p=0.0546] or 48.2% [p=0.0026]).
In addition, reductions in the use of rescue medication were observed in patients treated with the combination compared with those who used tiotropium alone (22% and 26% improvement in use of daytime and night-time rescue salbutamol, respectively) or olodaterol alone (13% and 18% improvement in use of daytime and night-time rescue salbutamol, respectively) (p<0.0001 for all comparisons).
The safety and tolerability of the combination were similar to that of tiotropium or olodaterol alone. The only common side-effect was dry mouth, which can be attributed to the anticholinergic properties of tiotropium.