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Clinical Investigations: COPD |

Ipratropium Bromide Hydrofluoroalkane Inhalation Aerosol Is Safe and Effective in Patients With COPD*

James Taylor, MD, FCCP; Arthur Kotch, MD, FCCP; Kathryn Rice, MD, FCCP; Mo Ghafouri, PhD; Caryn L. Kurland, PhD; Nora M. Fagan, MS; Theodore J. Witek, Jr, DrPH; the Ipratropium Bromide HFA Study Group
Author and Funding Information

Affiliations: *From Pulmonary Consultants (Dr. Taylor), Tacoma, WA; Danbury Hospital (Dr. Kotch), Danbury, CT; VA Medical Center (Dr. Rice), Minneapolis, MN; and Boehringer Ingelheim Pharmaceuticals, Inc. (Drs. Ghafouri, Kurland, Witek, and Ms. Fagan), Ridgefield, CT. ,  The study investigators are listed in the Appendix.

Correspondence to: Mo Ghafouri, PhD, Senior Associate Director, Clinical Research, Boehringer Ingelheim Pharmaceuticals, Inc., 900 Ridgebury Rd, PO Box 368, Ridgefield, CT 06877-0368; e-mail: mghafour@rdg.boehringer-ingelheim.com


Affiliations: *From Pulmonary Consultants (Dr. Taylor), Tacoma, WA; Danbury Hospital (Dr. Kotch), Danbury, CT; VA Medical Center (Dr. Rice), Minneapolis, MN; and Boehringer Ingelheim Pharmaceuticals, Inc. (Drs. Ghafouri, Kurland, Witek, and Ms. Fagan), Ridgefield, CT. ,  The study investigators are listed in the Appendix.


Chest. 2001;120(4):1253-1261. doi:10.1378/chest.120.4.1253
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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.

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