SESSION TITLE: COPD LAMA/LABA
SESSION TYPE: Original Investigation Slide
PRESENTED ON: Monday, October 27, 2014 at 01:30 PM - 02:30 PM
PURPOSE: To evaluate the bronchodilator effectiveness of combining two classes of long-acting bronchodilators (tiotropium and olodaterol) in separate devices in clinically stable patients with chronic obstructive pulmonary disease (COPD).
METHODS: In two replicate, double-blind, randomized, 12-week studies, we compared the effects of (a) olodaterol 5 µg once daily (qd) (via Respimat®) in combination with tiotropium 18 µg qd (via HandiHaler®) [T+O] with (b) tiotropium 18 µg qd (HandiHaler®) in combination with placebo (Respimat®) [T+P] in patients with moderate to severe COPD (ANHELTO-1 [NCT01694771] and ANHELTO-2 [NCT01696058]). Primary efficacy end points were area under the curve from 0-3 hours of forced expiratory volume in 1 second (FEV1 AUC0-3) and trough FEV1 responses (ie, change from baseline) after 12 weeks. Secondary end points included peak FEV1, AUC0-3 of forced vital capacity (FVC), and peak and trough FVC responses and rescue medication usage.
RESULTS: 1132 patients enrolled in ANHELTO-1 and 1135 in ANHELTO-2. Mean age was 64.6 and 64.1 years, respectively; 49.8% and 53.6%, respectively, were male. Mean baseline post-bronchodilator FEV1 was 54.0% and 53.3%, respectively. T+O resulted in significant improvements in lung function compared with T+P after 12 weeks. Mean FEV1 AUC0-3 responses were 0.196 L with T+P and 0.313 L with T+O in ANHELTO-1 (mean difference 0.117 L; p<0.0001); responses in ANHELTO‑2 were 0.191 and 0.297 L, respectively (mean difference 0.106 L; p<0.0001). Mean trough FEV1 responses were 0.133 L with T+P and 0.195 L with T+O in ANHELTO-1 (mean difference 0.062 L; p<0.0001); responses in ANHELTO‑2 were 0.135 and 0.175 L, respectively (mean difference 0.040 L; p=0.0029). Results of secondary end points supported these data.
CONCLUSIONS: Combining olodaterol (Respimat®) and tiotropium (HandiHaler®) qd provided significant bronchodilation above that achieved with tiotropium alone in patients with COPD.
CLINICAL IMPLICATIONS: Combination of tiotropium (HandiHaler®) and olodaterol (Respimat®) qd provides additional lung function improvement versus T+P in COPD. Funding: Boehringer Ingelheim. Editorial assistance: Complete HealthVizion.
DISCLOSURE: Richard ZuWallack: Consultant fee, speaker bureau, advisory committee, etc.: Honoraria from Boehringer-Ingelheim paid to my hospital, Grant monies (from industry related sources): Investigator initiated grants from Boehringer-Ingelheim to my institution, Consultant fee, speaker bureau, advisory committee, etc.: Honoraria from GSK for speaking paid to me Lisa Allen: Employee: Boehringer-Ingelheim Gemzel Hernandez: Employee: Boehringer-Ingelheim Naitee Ting: Employee: Boehringer-Ingelheim Roger Abrahams: Grant monies (from industry related sources): Clinical Research Grant from Boehringer-Ingelheim, Consultant fee, speaker bureau, advisory committee, etc.: Boehringer-Ingelheim steering committee
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