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

James Taylor, Arthur Kotch, Kathryn Rice, Mo Ghafouri, Caryn L. Kurland, Nora M. Fagan, Theodore J. Witek, Roblee Allen, Theodore Amgott, Horst Blumberg, Shari Anne Brazinsky, James R. Castle, Peter J. Costantini, William T. Ellison, Joe Garcia, W. Thomas Garland, Michael Goldman, Fredric Jackson, Mitchell Kaye, Steven KnoperArthur Kotch, Stephen M. Kreitzer, Robert Lapidus, H. Charles Miller, K. Scott Miller, M. Brooke Nicotra, Bohdan Pichurko, Kathryn L. Rice, Andrew Ries, Joseph Sokolowski, James Taylor, James Tita, Michael P. Tonner, Bernhard Votteri, Andrew S. Wachtel, Laurence A. Weiss, Lewis Wesselius, Jan Westerman

Research output: Contribution to journalArticlepeer-review

23 Scopus citations

Abstract

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.

Original languageEnglish (US)
Pages (from-to)1253-1261
Number of pages9
JournalCHEST
Volume120
Issue number4
DOIs
StatePublished - Oct 2001

Keywords

  • COPD
  • Chlorofluorocarbon
  • Hydrofluoroalkane-134a
  • Ipratropium bromide

ASJC Scopus subject areas

  • Pulmonary and Respiratory Medicine
  • Critical Care and Intensive Care Medicine
  • Cardiology and Cardiovascular Medicine

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