SESSION TITLE: COPD Treatment Posters
SESSION TYPE: Original Investigation Poster
PRESENTED ON: Wednesday, October 30, 2013 at 01:30 PM - 02:30 PM
PURPOSE: The efficacy of olodaterol 5 µg QD versus placebo has been demonstrated in a broad COPD population with moderate to very severe disease receiving background of usual-care COPD therapies. A post hoc pooled analysis was conducted to evaluate the efficacy of olodaterol in a subgroup of patients with moderate to severe disease (GOLD 2-3) who were not receiving background maintenance bronchodilator therapies (trial conditions more closely corresponding to traditional COPD bronchodilator studies).
METHODS: Four randomized, double-blind, placebo-controlled, parallel-group studies (NCT00782210; NCT00782509; NCT00793624; NCT00796653) investigated olodaterol 5 or 10 µg QD via Respimat® versus placebo for 48 weeks, with patients allowed to continue their usual COPD care during the trial, including SAMA, LAMA, ICS, and xanthines. Data from a subgroup of GOLD 2 or 3 patients not receiving SAMA, LAMA, xanthines, or beta-blockers as maintenance therapy during the study was pooled for analysis.
RESULTS: Of the 3104 patients from the total pooled study populations, 1127 were included in the subgroup. A higher treatment response to olodaterol 5 µg versus placebo over 48 weeks was observed in the subgroup compared to the full analysis set (FAS). Mean difference from placebo for FEV1 AUC0-3 response was 0.186 L in the subgroup compared to 0.161 L in the FAS. Mean trough FEV1 response (versus placebo) was 0.101 L in the subgroup compared to 0.071 L in the FAS. Within the subgroup, both FEV1 AUC0-3 and trough FEV1 responses were higher in GOLD 2 (0.197 and 0.121 L, respectively) compared to GOLD 3 patients (0.161 and 0.064 L, respectively).
CONCLUSIONS: The magnitude of bronchodilator response to olodaterol is influenced by baseline disease severity and background concomitant therapies.
CLINICAL IMPLICATIONS: Careful attention to the severity of disease and permitted background therapies is required when interpreting results from bronchodilator studies in COPD. Funding: Boehringer Ingelheim. Editorial assistance: Complete HealthVizion.
DISCLOSURE: Gary Ferguson: Grant monies (from industry related sources): Institution received grant rom Clinical trial centre for PRISM, Other: Institution received fees in return for Gary Ferguson's work as co-ordinating investigator , Other: Writing assistance received on manuscripts by sponsor of study to which manuscript relates Paul Sachs: Consultant fee, speaker bureau, advisory committee, etc.: Boehringer Ingelheim Alan Hamilton: Employee: Boehringer Ingelheim Kay Tetzlaff: Employee: Boehringer Ingelheim Lawrence Korducki: Employee: Boehringer Ingelheim Andrea Koch: Fiduciary position (of any organization, association, society, etc, other than ACCP: Member of the board for German Atemwegsliga, German Society of Pneumology (DGP), Other: Received fees for expert testimony from Boehringer Ingelheim, Germany, Berlin-Chemie, GlaxoSmithKline,, Grant monies (from industry related sources): MSD, Boehringer Ingelheim, Actelion, Bayer, Other: Travel and accommodation expenses received for activities carried out on behalf of Boehringer Ingelheim Germany,
Submitted to regulatory authority for marketing approval