Rationale The combination of tiotropium (T), a long-acting muscarinic antagonist (LAMA), plus olodaterol (O), a long-acting β2-agonist (LABA), is approved for once-daily maintenance treatment of COPD. The randomised, double-blind, Phase IIIb OTEMTO® 1 and 2 studies (NCT01431274; NCT01431287) showed improvements in quality of life and lung function after 12 weeks’ treatment with T/O compared to T alone or placebo in patients with moderate to severe COPD. This post hoc analysis investigated whether previous maintenance treatment with a long-acting bronchodilator or inhaled corticosteroid (ICS) influenced symptomatic benefits of T/O.
Methods Patients aged ≥40 years received T/O 2.5/5 µg, T/O 5/5 µg, T 5 µg or placebo once daily for 12 weeks via Respimat® inhaler. St George’s Respiratory Questionnaire (SGRQ) total score was a primary end point, alongside lung function (FEV1 area under the curve from 0–3 hours and trough FEV1 responses). Secondary end points included Mahler Transition Dyspnoea Index (TDI) focal score. Salbutamol/albuterol was provided as rescue medication and use was recorded in an e-diary. We report comparisons between T/O 5/5 µg, T 5 µg and placebo.
Results Of the 1621 patients evaluated, 943 had received prior maintenance treatment (66.7% LABA; 59.4% LAMA; 64.5% ICS) and 678 had not. Similar improvements in mean SGRQ total score were observed with T/O compared to T and placebo, respectively, in patients receiving prior maintenance treatment (−2.02 and −4.59 units) and those without (−2.20 and −4.78 units) (Table). TDI focal scores improved with T/O compared to T and placebo, respectively, in patients receiving prior maintenance treatment (0.60 and 1.87 units) and those without (0.60 and 1.33 units) (Table). Patients with and without prior maintenance treatment demonstrated similar improvements in daytime and night-time rescue medication use and lung-function improvements with T/O compared to T and placebo.
Conclusions T/O provides symptomatic benefits as demonstrated by improvements in SGRQ score, TDI focal score and decreased rescue medication use compared to placebo and T, independent of previous maintenance treatment. These findings suggest T/O is beneficial over monotherapy when used as first COPD maintenance treatment.
Funding Boehringer Ingelheim.
Please refer to page A273 for declarations of interest in relation to abstract P298.