Rationale Tiotropium (T), a long-acting muscarinic antagonist, and olodaterol (O), a long-acting β2-agonist (both administered once daily), have been studied as a once-daily combination. Two Phase III studies have demonstrated that T+O significantly improved lung function and symptoms over T and O monotherapy treatments in patients with moderate to very severe chronic obstructive pulmonary disease (COPD).1 During these studies, patients were allowed to continue existing treatment with inhaled corticosteroids (ICS); this analysis was conducted to determine the effects of study treatment in patients receiving or not receiving ICS as reported at baseline.
Methods A total of 5162 patients were randomised to treatment with O 5 µg, T 2.5 µg, T 5 µg, T+O 2.5/5 µg or T+O 5/5 µg (Respimat® inhaler) in two 52-week, double-blind, parallel-group studies (NCT01431274 and NCT01431287). Primary efficacy end points were trough forced expiratory volume in 1 s (FEV1) response (ie, change from baseline), FEV1 area under the curve from 0–3 h (AUC0–3) response and St George’s Respiratory Questionnaire (SGRQ) total score after 24 weeks. Pooled data are presented for the patient subgroups either using or not using ICS at baseline.
Results In the overall population, all treatments resulted in clinically relevant improvements in lung function, with significant increases with both T+O doses over the individual components (p < 0.01).1 These effects on lung function were observed irrespective of whether or not patients had reported concomitant use of ICS at baseline (see Table 1). In the ‘ICS usage’ and ‘no ICS usage’ subgroups, there were no statistically significant differences between the combinations and monotherapy treatments in changes in SGRQ total scores from baseline to Week 24, although SGRQ total scores were improved during this period with T+O.
Conclusions In patients with COPD, T+O 5/5 µg significantly improved lung function over T 5 µg and O 5 µg monotherapy, irrespective of whether patients had reported ICS use at baseline.
Funding Boehringer Ingelheim.
Reference 1 Buhl R, et al. Eur Respir J. 2015;45:969–979