SESSION TITLE: COPD Posters V
SESSION TYPE: Original Investigation Poster
PRESENTED ON: Wednesday, October 28, 2015 at 01:30 PM - 02:30 PM
PURPOSE: Night-time rescue medication has been suggested as a possible marker of symptom control in chronic obstructive pulmonary disease (COPD).1 This analysis evaluated the effects of tiotropium (T) + olodaterol (O) on use of night-time rescue medication in patients with COPD.
METHODS: Two sets of replicate, double-blind, parallel-group studies (52-week TONADO 1 and 2 [NCT01431274; NCT01431287]2 and 12-week OTEMTO 1 and 2 [NCT01964352; NCT02006732]) compared the efficacy of T+O 5/5 μg and T+O 2.5/5 μg with T 5 or 2.5 μg, O 5 μg, and placebo (OTEMTO only), all delivered once daily (QD) via Respimat® with salbutamol/albuterol provided as rescue medication. Number of puffs of rescue medication taken during the day and night were determined by patients and recorded in an electronic diary.
RESULTS: 2624 patients were treated in TONADO 1, 2538 in TONADO 2, 812 in OTEMTO 1, and 809 in OTEMTO 2 (6783 in total). Common mean at baseline for night-time rescue medication use was 2.22 and 2.18 puffs/night in TONADO 1 and 2, and 2.06 and 1.96 in OTEMTO 1 and 2. Overall, there was a sustained reduction in weekly mean night-time rescue medication use with T+O 5/5 and 2.5/5 μg compared to baseline with smaller but sustained reductions for T and O monotherapies. In TONADO, a significant reduction in night-time rescue medication use with T+O versus T was observed over the trial period, with numerical reductions seen versus O. At Week 52, the treatment difference was -0.54 puffs/night for T+O 5/5 μg versus T 5 μg (p<0.0001) and -0.35 versus O 5 μg (p<0.01) in TONADO 1, and -0.58 for T+O 5/5 μg versus T 5 μg (p<0.0001) and -0.20 versus O 5 μg (p=0.11) in TONADO 2. In OTEMTO, night-time rescue medication use was significantly lower with T+O 5/5 μg versus placebo in both trials (mean treatment difference at Week 12 -1.02 in OTEMTO 1 and -0.98 in OTEMTO 2; p<0.001 for both) and significantly lower with T+O 5/5 μg versus T in OTEMTO 1 (mean treatment difference at Week 12 -0.64; p<0.001).
CONCLUSIONS: Further reductions in night-time rescue medication use were demonstrated with T+O QD for up to 52 weeks compared to monotherapy.
CLINICAL IMPLICATIONS: QD maintenance treatment with T+O reduces the need for night-time rescue medication in patients with moderate to very severe COPD. Funding: Boehringer Ingelheim. Editorial assistance: Complete HealthVizion.
DISCLOSURE: Roger Abrahams: Grant monies (from industry related sources): Clinical Research - BI, GSK, Astra Zeneca 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 Lawrence Korducki: Employee: Boehringer Ingelheim Nathan Bennett: Employee: Boehringer Ingelheim Roland Buhl: Grant monies (from industry related sources): Support for Investigator Initiated Trials (IITs) from Boehringer Ingelheim,
GlaxoSmithKline, Novartis and Roche, Grant monies (from industry related sources): Grants from the German Research Foundation, Consultant fee, speaker bureau, advisory committee, etc.: Reimbursement for attending scientific conferences,and/or fees for speaking and/or
consulting from AstraZeneca,Boehringer Ingelheim, Chiesi, GlaxoSmithKline, Grifols, Novartis, Roche, and Takeda
Tiotripium+Olodaterol 5/5ug has been submitted to European and US regulatory authorities; currently awaiting approval decision