NEW ORLEANS — In a post hoc analysis of pooled data from four phase 3 studies, combination therapy with tiotropium plus olodaterol resulted in greater improvements in lung function and symptoms than with tiotropium alone in patients with COPD who were not using inhaled corticosteroids.
“Generally, patients who are enrolled in bronchodilator studies are continuing to take inhaled corticosteroids,” Peter M.A. Calverley, MBChB, professor of respiratory medicine at the University of Liverpool in the United Kingdom, said during a presentation at the CHEST Annual Meeting. “Many of the studies I have been involved in have been looking at exacerbations of disease, and inhaled corticosteroid use is a marker for that. However, that then leaves us with a knowledge gap in that we really want to know how well these treatments work in patients who are not regularly using inhaled corticosteroids.”
To gain insight into treatment for this patient population, Calverley and colleagues evaluated pooled data from the TONADO 1 and 2 and the OTEMTO 1 and 2 phase 3 trials in patients with COPD. Specifically, they examined treatment differences in trough FEV1 response and change from baseline in St. George’s Respiratory Questionnaire (SGRQ) total score and Transition Dyspnea Index (TDI) score at 12 weeks between 1,581 steroid-free patients who were taking tiotropium/olodaterol (Stiolto Respimat, Boehringer Ingelheim) or tiotropium alone at 12 weeks.
Results showed greater improvement in trough FEV1 after treatment with tiotropium/olodaterol vs. tiotropium alone (treatment difference, 0.054 L; P < .0001). In subgroup analyses, similar improvements of about 0.05 L, all of which were statistically significant, were observed among patients on combination therapy vs. monotherapy, regardless of GOLD stage, Beck Depression Inventory scores or SGRQ total scores at baseline.
TDI score also increased among patients treated with tiotropium/olodaterol vs. tiotropium alone at 12 weeks (treatment difference, 0.575; P < .0001) — an improvement that again was seen across all GOLD stage, BDI and SGRQ subgroups.
In keeping with other improvements observed with combination therapy, SGRQ total score decreased among patients in the tiotropium/olodaterol group, compared with the tiotropium alone group, at 12 weeks (treatment difference, –1.918; P = .0005). The researchers noted that SGRQ score from baseline also decreased significantly among both patients who were GOLD stage II and those who were GOLD stage III.
“In these pooled data of over 1,500 people who were not taking inhaled corticosteroids for COPD, optimizing bronchodilator treatment with tiotropium/olodaterol significantly improved lung function, symptoms and quality of life, irrespective of disease severity and baseline symptoms. These improvements are broadly consistent across all subgroups of severity and symptomatology, and perhaps, frustratingly, we can’t personalize therapy,” Calverley said.
“Clearly, dual bronchodilator therapy improves key COPD outcomes over single bronchodilator therapy, and this perhaps accounts for why it’s being picked up as an earlier treatment option in some guidelines.” – by Melissa Foster
Calverley PMA. Late Breaking Abstracts. Presented at: CHEST Annual Meeting; Oct. 19-23, 2019; New Orleans.
Disclosures: Calverley reports he has received personal fees from AstraZeneca, Recipharm and Zambon; grants and personal fees from GlaxoSmithKline; and personal and other fees from Boehringer Ingelheim.