SESSION TYPE: COPD Posters II
PRESENTED ON: Wednesday, October 24, 2012 at 01:30 PM - 02:30 PM
PURPOSE: Chronic obstructive pulmonary disease (COPD) medications are preferentially delivered via oral inhalers. This study evaluated the long-term safety and patient acceptance of Combivent Respimat Inhalation Spray (CVT-R; ipratropium plus albuterol) compared with Combivent metered-dose inhaler (CVT-MDI) using a CFC propellant and the free combination of ipratropium HFA plus albuterol HFA metered dose inhalers (I+A).
METHODS: In this Phase III, 1-year, open-label, randomized study, COPD patients received CVT-R, CVT-MDI, or I+A for 48 weeks. Adverse events (AEs) were recorded at each visit; all patients who received ≥1 dose of study medication were included in the safety analysis. Acceptance was assessed using a patient satisfaction questionnaire.
RESULTS: Of 688 patients enrolled at 55 US sites, 470 were randomized, and 465 received study medication. Baseline demographics were similar in all groups. The percent of patients with AEs was similar (CVT-R: 69.4%; CVT-MDI: 72.7%; I+A: 74.0%; Table); those with AEs leading to discontinuation (7.0%, 9.7%, and 12.3%, respectively) was lower with CVT-R. Serious AEs were similar between groups (14.6%, 13.0%, and 16.2%, respectively). Fewer fatal AEs occurred with CVT-R (0.6%, 1.3%, and 2.6%, respectively), with each death reviewed—none considered related to study drug. Patients receiving CVT-R withdrew from the study in fewer numbers, (24, 36 [p>0.05], 44 [p=0.0059], respectively), and time to withdrawal was prolonged vs I+A (p=0.0046).
CONCLUSIONS: The long-term safety profile of CVT-R was comparable to CVT-MDI and I+A, with fewer withdrawals and numerically lower mortality rates in those receiving CVT-R.
CLINICAL IMPLICATIONS: CVT-R is a safe alternative to CVT-MDI.
DISCLOSURE: Gary Ferguson: Consultant fee, speaker bureau, advisory committee, etc.: Provided consultative services, participated in advisory boards, received research funding support and is on the speaker bureaux for Boehringer Ingelheim Pharmaceuticals Inc and Pfizer Inc.
Mo Ghafouri: Employee: Employee of Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT
Luyan Dai: Employee: Employee of Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT
Leonard Dunn: Consultant fee, speaker bureau, advisory committee, etc.: Received consultant fees from Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT
No Product/Research Disclosure InformationPulmonary Research Institute of Southeast Michigan, Livonia, MI