Tiotropium/Olodaterol Significantly Benefits Steroid-Free COPD Patients

Dr. Peter M.A. Calverley

Dual inhaler therapy tiotropium/olodaterol (T/O; Stiolto) significantly improved lung function and quality of life symptoms among patients with chronic obstructive pulmonary disease (COPD) when compared to monotherapy in new study results.

In a late-breaking data presentation at the CHEST 2019 Annual Meeting in New Orleans this week, Dr. Peter M.A. Calverley of the Clinical Science Center, Institute of Aging and Chronic Disease, University of Liverpool, showed findings indicating steroid-free patients with COPD benefitted significantly from the long-acting meta antagonist/long-acting beta agonist (LAMA/LABA) dual therapy.

The new data adds to a relatively small focus of COPD clinical evidence showing the effect of LAMA/LABA therapy among patients not already on therapies including inhaled corticosteroid (ICS).

Calverley and colleagues pooled data from the TONADO 1 and 2, and OTEMTO 1 and 2, phase 3 clinical trials—particularly, that of patients with COPD who were not receiving lone or combination ICS at baseline. They conducted subgroup analyses by GOLD (stages 2 and 3) and symptoms at baseline including bronchodilation (as per BDI) and the St. George’s Respiratory Questionnaire (SGRQ).

The team sought to understand the effectiveness of dual bronchodilator therapy in patients not using ICS, and to compare the efficacy and safety of T/O 5/5 mcg versus tiotropium 5 mcg monotherapy in the same patient population.

Their patient population included 1596 patients from the TONADO studies (GOLD stage 2-4) and 506 patients from the OTEMTO studies (GOLD stage 2-3) not on ICS at baseline, split to either dual or monotherapy. At week 12, investigators examined trough forced expiratory volume at 1 second (FEV₁), transition dyspnea indexes (TDI), and SGRQ total score change from baseline.

Patient demographics across T/O (n = 771) and tiotropium (n = 825) were similar; mean T/O patient age was 63.6 years, with 68.1% being male, and 51.8% being an ex-smoker. Mean baseline SGRQ score was 42.0, and BDI score was 6.7.

Calverley reported patients on T/O had significantly greater improvement in trough FEV₁ change versus tiotropium in all patients, and by GOLD subgroups, at week 12. Overall, T/O patients reported a 0.054 L improvement in adjusted mean response at 85 days (0.141 vs 0.086; 95% CI, .036 - .073; P <.0001).

Similar improvement across all patient groups and subgroups were reported in SGRQ total score changes, with overall patients treated with T/O reporting a 1.918-point greater mean adjusted response at 85 days versus tiotropium patients (-6.317 vs -4.309; 95% CI, -2.994 to -0.843; P = .0005).

Investigators concluded optimizing bronchodilator treatment with T/O was associated with a significantly improved lung function, symptoms, and COPD patient quality of life versus tiotropium monotherapy among steroid-free patients—irrespective of disease severity and baseline symptoms.

“These improvements were consistent across all subgroups of severity and symptomatology—and perhaps frustratingly, we can’t personalize the medicine,” Calverley said at CHEST. “Everybody seemed to get benefit across the board, and that benefit was broadly similar.”

As a result of their findings, Calverley suggested T/O become considered as an earlier treatment option for most patients beginning care for COPD.

The study, “Tiotropium/olodaterol therapy improves lung function, symptoms and impact of disease versus monotherapies in steroid-free patients with COPD,” was presented at CHEST 2019.