ATLANTA, Georgia — Patients with chronic obstructive pulmonary disease (COPD) experience few adverse events and discontinuations when treated with an ipratropium plus albuterol inhalation spray (CVT-R; Combivent Respimat, Boehringer Ingelheim) than when treated with the same drug formulated as a metered-dose inhaler (CVT-MDI), according to a large randomized controlled trial.
Gary Ferguson, MD, from the Pulmonary Research Institute of Southeast Michigan in Livonia, reported the findings in a poster presentation here at CHEST 2012: American College of Chest Physicians Annual Meeting.
CVT-MDI "is the last metered-dose inhaler on the market that has been given a waiver to allow chlorofluorocarbons [CFC]," Dr. Ferguson told Medscape Medical News during the poster session. "The purpose of this study was to show that the Respimat delivery system in conjunction with these known medicines is effective and well tolerated," he said.
According to Dr. Ferguson, because CFCs are known to harm the environment by depleting the ozone layer, "CVT-MDI is being phased out and will not be available for sale after December 2013."
Respimat is a novel CFC-propellant-free inhaler device that relies on a mechanical spring to generate a slow-moving cloud of medicine. The US Food and Drug Administration recently approved the Respimat inhaler for patients with COPD.
Dr. Ferguson and colleagues sought to compare patient acceptance and the long-term safety of CVT-R, CVT-MDI, and the free combination of ipratropium bromide plus albuterol (I+A). A total of 688 patients with COPD were enrolled in this phase 3 open-label randomized study, which lasted 48 weeks.
Adverse events were similar in the CVT-R, CVT-MDI, and I+A groups (69.4% vs 72.7% vs 74.0%), but the number of patients with adverse events leading to discontinuation was lower with CVT-R than with CVT-MDI or I+A (7.0% vs 9.7% vs 12.3%). Serious adverse events were similar in the 3 groups, ranging from 13% to just over 16% of patients. Fewer fatal adverse events occurred with CVT-R than with CVT-MDI or I+A (0.6% vs 1.3% vs 2.6%), although none considered to be related to the study drug.
Fewer patients in the CVT-R group than in the other 2 groups withdrew from the study (P = .0059). In addition, the risk of withdrawing from the study early was significantly lower in the CVT-R group than in the I+A group (hazard ratio, 0.487; P = .0046). According to Dr. Ferguson, this "highlights the tolerability of CVT-R."
"We looked at all the adverse events and showed that, at the end of the day, CVT-R is as safe as or safer across the board in all of these outcomes, with no problems at all," he explained.
According to Dr. Ferguson, the manufacturer is now developing newer drugs to be used with the Respimat device, which has been approved in Europe for about 15 years.
Richard ZuWallack, MD, a pulmonologist from the Saint Francis Medical Group in Hartford, Connecticut, told Medscape Medical News that he thinks the data are reassuring. This is an "effective combination bronchodilator, delivered by a new device that is quite popular with patients, and has a good safety profile," he said.
The study was funded by Boehringer Ingelheim Pharmaceuticals and Pfizer. The study authors report financial relationships with Boehringer Ingelheim and Pfizer. Dr. ZuWallack has disclosed no relevant financial relationships.
CHEST 2012: American College of Chest Physicians Annual Meeting. Presented October 24, 2012.
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Cite this: Combivent Inhalation Spray as Safe as Metered-Dose Inhaler - Medscape - Oct 31, 2012.