SESSION TITLE: Emerging Therapies in COPD
SESSION TYPE: Original Investigation Slide
PRESENTED ON: Tuesday, October 27, 2015 at 02:45 PM - 04:15 PM
PURPOSE: To determine whether the response to tiotropium (T) + olodaterol (O) in patients (pts) with COPD differs across age groups.
METHODS: Two sets of randomized, double-blind, parallel-group studies (52-week TONADO 1 & 2 [NCT01431274; NCT01431287] and 12-week OTEMTO 1 & 2 [NCT01964352; NCT02006732]) investigated the efficacy of T+O 2.5/5 µg or 5/5 µg once daily (QD) compared to T 2.5 or 5 µg QD, O 5 µg, or placebo, via Respimat®, in pts with moderate to very severe (only TONADO) COPD. Key end points were forced expiratory volume in 1 s (FEV1), area under the curve from 0-3 h post-dose (AUC0-3), and trough FEV1. This analysis evaluates the response to T+O in pts <65, 65-<75, 75-<85, and ≥85 years (y) old.
RESULTS: 5162 pts were treated in the TONADO studies (2654 aged <65 y, 1967 aged 65-<75 y, 528 aged 75-<85 y, and 13 aged ≥85 y), and 1621 were treated in OTEMTO 1 & 2 (365 and 384 aged <65 y, 343 and 331 aged 65-<75 y, 99 and 87 aged 75-<85 y, and 5 and 7 aged ≥85 y, respectively). T+O 5/5 µg improved FEV1 AUC0-3 compared to monocomponents across all age groups after 24 weeks in TONADO 1 & 2. Treatment differences in adjusted mean FEV1 AUC0-3 responses for T+O 5/5 µg versus T 5 µg or O 5 µg (combined analysis of both studies) were 0.120 L and 0.151 L in pts aged <65 y, 0.104 L and 0.096 L in pts aged 65-<75 y, and 0.085 L and 0.126 L in pts aged 75-<85 y, respectively (all comparisons p<0.0001). In OTEMTO 1 & 2, treatment differences in adjusted mean FEV1 AUC0-3 responses for T+O versus T 5 µg or placebo after 12 weeks were 0.116 L (p=0.0003), 0.376 L (p<0.0001) and 0.094 L (p=0.004), 0.322 L (p<0.0001) in pts aged <65 y; 0.120 L, 0.292 L and 0.120 L, 0.303 L (all p<0.0001) in pts aged 65-<75 y; and 0.085 L (p=0.18), 0.301 (p<0.0001) and 0.092 L (p=0.21), 0.174 L (p=0.24) in pts aged 75-<85 y, respectively. T+O 5/5 µg generally improved trough FEV1 response compared to monocomponents or placebo across age groups in both sets of studies; there was a trend towards smaller improvement in pts aged 75-<85 y. T+O 2.5/5 µg gave similar results in both sets of studies.
CONCLUSIONS: T+O showed generally greater improvements in lung function compared to monocomponents or placebo across all age groups, consistent between studies.
CLINICAL IMPLICATIONS: Data from these studies demonstrate lung-function responses with T+O across age groups, including elderly pts with COPD. Funding: Boehringer Ingelheim. Editorial assistance: Complete HealthVizion.
DISCLOSURE: Gary Ferguson: Grant monies (from industry related sources): Boehringer Ingelheim, Novartis, Pearl Therapeutics, AstraZeneca, Sunovian, Forest/Almirall, Consultant fee, speaker bureau, advisory committee, etc.: Boehringer Ingelheim, Novartis, Sunovian, AstraZeneca, Pearl Therapeutics, Fiduciary position (of any organization, association, society, etc, other than ACCP: GlaxoSmithKline Emmanuelle Clerisme-Beaty: Employee: Boehringer Ingelheim Lars Groenke: Employee: Boehringer Ingelheim Florian Voss: Employee: Boehringer Ingelheim Jill Karpel: Grant monies (from industry related sources): Boehringer Ingelheim
Tiotripium+Olodaterol 5/5ug has been submitted to European and US regulatory authorities; currently awaiting approval decision