Characteristics of Patients With and Without COPD Exacerbations During the Tiotropium + Olodaterol TONADO Studies

Abstract

SESSION TITLE: Airways 3 SESSION TYPE: Original Investigation Poster PRESENTED ON: Wednesday, October 26, 2016 at 01:30 PM - 02:30 PM PURPOSE: The efficacy and safety of once-daily tiotropium + olodaterol (T+O) in moderate to very severe COPD were demonstrated in the pivotal, Phase III TONADO studies. Preventing exacerbations is a key aim of COPD management due to their adverse effects on lung function and patients’ health status. We investigated characteristics of patients with/without COPD exacerbations in the TONADO studies. METHODS: TONADO 1 and 2 were replicate, 52-week, double-blind, parallel-group studies (1237.5, NCT01431274; 1237.6, NCT01431287). Patients received once-daily T+O 2.5/5 or 5/5 µg, T 2.5 or 5 µg, or O 5 µg via the Respimat® inhaler. Continuation of prescribed ICS was permitted. Characteristics of patients with/without a moderate or severe COPD exacerbation during the study are presented. RESULTS: Of 5162 patients, there were 1484/3678 (28.7%/71.3%) with/without a moderate or severe on-study COPD exacerbation: T+O 5/5 µg (285/744), T 5 µg (297/736), and O 5 µg (331/707). Demographics were generally similar including mean age (64.4/63.8 years) and the proportions of current smokers (35.7%/37.5%) and their mean pack-years (46.9/45.9), but there were more women (32.5%/25.0%) and fewer Asian patients (18.2%/28.2%) in the exacerbation group. Patients who had an on-study exacerbation were more likely to have had an exacerbation in the past year (804/1392 [54.2%/37.8%]), and have received at least one course of antibiotics (52.5%/37.1%) and oral or intravenous steroids (39.8%/22.1%) in the past year. The exacerbation group had longer median (range) duration of COPD (6.0 [0-43.0]/4.8 [0-45.3] years), had lower post-bronchodilator mean FEV1 (1.238/1.429 L) and a higher proportion were GOLD 3/4 (60.6%/45.4%). Pulmonary medication use at baseline was higher in the exacerbation group (87.6%/76.3%), including ICS use at baseline (59.2%/42.6%). CONCLUSIONS: While demographics were similar in patients with and without on-study exacerbations, patients with exacerbations had longer duration of COPD and more severe COPD in terms of lung function, prior exacerbations, and use of baseline pulmonary and other medications. CLINICAL IMPLICATIONS: Analysis of this population, in which approximately one-third of patients had an exacerbation, confirms earlier findings that prior exacerbations are the major risk factor for future events. Funding: Boehringer Ingelheim. Editorial assistance: Complete HealthVizion. DISCLOSURE: Roger Abrahams: Other: Boehringer-Ingelheim Gary Ferguson: Consultant fee, speaker bureau, advisory committee, etc.: Boehringer-Ingelheim, AstraZeneca, Pearl Therapeutics, Novartis, Forest, Sunovion, Verona, Receptos, GlaxoSmithKline, Other: Boehringer-Ingelheim, AstraZeneca, Pearl Therapeutics, Sunovion, Sunovion, Theravance, Sanofi, Forest, GlaxoSmithKline Florian Voss: Employee: Boehringer-Ingelheim Pharma GmbH & Co. KG Carlos Tafur: Employee: Boehringer-Ingelheim Roland Buhl: Consultant fee, speaker bureau, advisory committee, etc.: AstraZeneca, Boehringer-Ingelheim, Chiesi, GlaxoSmithKline, Novartis, TEVA, Roche, Other: Boehringer-Ingelheim, GlaxoSmithKline, Novartis, Roche The following authors have nothing to disclose: Leif Bjermer, Emilio Pizzichini No Product/Research Disclosure Information