Allergy and Airway |

Health Status of Patients With COPD Receiving the Combination of Olodaterol Respimat and Tiotropium HandiHaler Compared With Tiotropium: Results From Two Replicate, Randomized, Double-Blind Studies FREE TO VIEW

Richard ZuWallack; Lisa Allen; Gemzel Hernandez; Naitee Ting; Roger Abrahams
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St Francis Hospital and Medical Center, Hartford, CT

Chest. 2014;146(4_MeetingAbstracts):46A. doi:10.1378/chest.1994369
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SESSION TITLE: COPD Treatment Posters

SESSION TYPE: Original Investigation Poster

PRESENTED ON: Wednesday, October 29, 2014 at 01:30 PM - 02:30 PM

PURPOSE: To determine whether combining long-acting β-agonists (LABAs) with long-acting muscarinic antagonists (LAMAs) once daily will improve the health status of patients with chronic obstructive pulmonary disease (COPD).

METHODS: We report on two replicate, double-blind, randomized, 12-week studies comparing the effects of (a) the free combination of the LABA olodaterol 5 µg once daily (via Respimat®) and the LAMA tiotropium 18 µg once daily (via HandiHaler®) [T+O] with (b) tiotropium 18 µg once daily (HandiHaler®) in combination with placebo (Respimat®) [T+P] on health status in patients with moderate to severe COPD (ANHELTO-1 [NCT01694771] and ANHELTO-2 [NCT01696058]). Health-related quality of life was evaluated using St. George’s Respiratory Questionnaire (SGRQ) total scores, and symptoms, activity, and impact sub-scores; these were assessed on Day 1 and Week 12. SGRQ total score at Week 12 from the combined dataset was identified as a key secondary end point.

RESULTS: The mean SGRQ was lower (improved) at Week 12 with T+O (41.2) than with T+P (43.1); the mean (standard error) difference between treatments was -1.85 (0.46; p<0.0001). SGRQ subscale scores were also lower with T+O than T+P at Week 12: mean (95% confidence interval) differences between treatments were ‑3.771 (-5.232, -2.309) for SGRQ symptom score, -1.791 (-2.945, -0.636) for SGRQ activity score, and -1.145 (-2.125, -0.165) for SGRQ impact score.

CONCLUSIONS: Compared with tiotropium alone, the use of olodaterol with tiotropium once daily resulted in a significant, further improvement in health-related quality of life in patients with COPD.

CLINICAL IMPLICATIONS: Combining tiotropium (HandiHaler®) and olodaterol (Respimat®) once daily provides benefits for patients’ health status 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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