Ipratropium bromide hydrofluoroalkane inhalation aerosol is safe and effective in patients with COPD

Study objective: To compare the efficacy and safety of ipratropium bromide reformulated with the chlorofluorocarbon (CFC)-free propellant hydrofluoroalkane (HFA)-134a (ipratropium bromide HFA) to that of the marketed ipratropium bromide inhalation aerosol (containing CFC) in patients with COPD. Design: This was a randomized, double-blind, parallel-group, placebo-controlled, multicenter trial. The primary efficacy parameter was acute bronchodilator response. The primary end points were peak change in FEV₁ from baseline and area under the response-time curve. Setting: Thirty-one clinical centers in the United States participated in this project. Patients: A total of 507 patients with moderate-to-severe COPD were randomized, and 444 patients completed the trial. Interventions: Twelve weeks of treatment four times daily with one of the following: ipratropium bromide HFA, 42 μg; ipratropium bromide HFA, 84 μg; HFA placebo; ipratropium bromide inhalation aerosol, 42 μg; or CFC placebo. Measurements and results: Patients in all active treatment groups had significant bronchodilator responses as shown by increases in mean FEV₁ from baseline of at least 15%. Bronchodilator response in all active treatment groups was also significantly more than their respective placebo treatments based on FEV₁, area under the time-response curve from 0 to 6 h, and peak response. FVC results were similar to those seen with FEV₁. There were no significant differences in adverse events, laboratory findings, or ECG findings among the treatment groups. Conclusions: Ipratropium bromide HFA, 42 μg, provided bronchodilation comparable to the marketed ipratropium bromide CFC, 42 μg, over 12 weeks of regular use.