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

J. Taylor, A. Kotch, K. Rice, M. Ghafouri, C. L. Kurland, N. M. Fagan, Jr Witek T.J., R. Allen, T. Amgott, H. Blumberg, S. A. Brazinsky, J. R. Castle, P. J. Costantini, W. T. Ellison, Joe GN Garcia, W. T. Garland, M. Goldman, F. Jackson, M. Kaye, Steven R KnoperA. Kotch, S. M. Kreitzer, R. Lapidus, H. C. Miller, K. S. Miller, M. B. Nicotra, B. Pichurko, K. L. Rice, A. Ries, J. Sokolowski, J. Taylor, J. Tita, M. P. Tonner, B. Votteri, A. S. Wachtel, L. A. Weiss, L. Wesselius, J. Westerman

Research output: Contribution to journalArticle

23 Citations (Scopus)

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 - 2001
Externally publishedYes

Fingerprint

HFA 134a
Ipratropium
Aerosols
Chronic Obstructive Pulmonary Disease
Inhalation
Chlorofluorocarbons
Bronchodilator Agents
Placebos
Therapeutics

Keywords

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

ASJC Scopus subject areas

  • Pulmonary and Respiratory Medicine

Cite this

Taylor, J., Kotch, A., Rice, K., Ghafouri, M., Kurland, C. L., Fagan, N. M., ... Westerman, J. (2001). Ipratropium bromide hydrofluoroalkane inhalation aerosol is safe and effective in patients with COPD. Chest, 120(4), 1253-1261. https://doi.org/10.1378/chest.120.4.1253

Ipratropium bromide hydrofluoroalkane inhalation aerosol is safe and effective in patients with COPD. / Taylor, J.; Kotch, A.; Rice, K.; Ghafouri, M.; Kurland, C. L.; Fagan, N. M.; Witek T.J., Jr; Allen, R.; Amgott, T.; Blumberg, H.; Brazinsky, S. A.; Castle, J. R.; Costantini, P. J.; Ellison, W. T.; Garcia, Joe GN; Garland, W. T.; Goldman, M.; Jackson, F.; Kaye, M.; Knoper, Steven R; Kotch, A.; Kreitzer, S. M.; Lapidus, R.; Miller, H. C.; Miller, K. S.; Nicotra, M. B.; Pichurko, B.; Rice, K. L.; Ries, A.; Sokolowski, J.; Taylor, J.; Tita, J.; Tonner, M. P.; Votteri, B.; Wachtel, A. S.; Weiss, L. A.; Wesselius, L.; Westerman, J.

In: Chest, Vol. 120, No. 4, 2001, p. 1253-1261.

Research output: Contribution to journalArticle

Taylor, J, Kotch, A, Rice, K, Ghafouri, M, Kurland, CL, Fagan, NM, Witek T.J., J, Allen, R, Amgott, T, Blumberg, H, Brazinsky, SA, Castle, JR, Costantini, PJ, Ellison, WT, Garcia, JGN, Garland, WT, Goldman, M, Jackson, F, Kaye, M, Knoper, SR, Kotch, A, Kreitzer, SM, Lapidus, R, Miller, HC, Miller, KS, Nicotra, MB, Pichurko, B, Rice, KL, Ries, A, Sokolowski, J, Taylor, J, Tita, J, Tonner, MP, Votteri, B, Wachtel, AS, Weiss, LA, Wesselius, L & Westerman, J 2001, 'Ipratropium bromide hydrofluoroalkane inhalation aerosol is safe and effective in patients with COPD', Chest, vol. 120, no. 4, pp. 1253-1261. https://doi.org/10.1378/chest.120.4.1253
Taylor, J. ; Kotch, A. ; Rice, K. ; Ghafouri, M. ; Kurland, C. L. ; Fagan, N. M. ; Witek T.J., Jr ; Allen, R. ; Amgott, T. ; Blumberg, H. ; Brazinsky, S. A. ; Castle, J. R. ; Costantini, P. J. ; Ellison, W. T. ; Garcia, Joe GN ; Garland, W. T. ; Goldman, M. ; Jackson, F. ; Kaye, M. ; Knoper, Steven R ; Kotch, A. ; Kreitzer, S. M. ; Lapidus, R. ; Miller, H. C. ; Miller, K. S. ; Nicotra, M. B. ; Pichurko, B. ; Rice, K. L. ; Ries, A. ; Sokolowski, J. ; Taylor, J. ; Tita, J. ; Tonner, M. P. ; Votteri, B. ; Wachtel, A. S. ; Weiss, L. A. ; Wesselius, L. ; Westerman, J. / Ipratropium bromide hydrofluoroalkane inhalation aerosol is safe and effective in patients with COPD. In: Chest. 2001 ; Vol. 120, No. 4. pp. 1253-1261.
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title = "Ipratropium bromide hydrofluoroalkane inhalation aerosol is safe and effective in patients with COPD",
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.",
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author = "J. Taylor and A. Kotch and K. Rice and M. Ghafouri and Kurland, {C. L.} and Fagan, {N. M.} and {Witek T.J.}, Jr and R. Allen and T. Amgott and H. Blumberg and Brazinsky, {S. A.} and Castle, {J. R.} and Costantini, {P. J.} and Ellison, {W. T.} and Garcia, {Joe GN} and Garland, {W. T.} and M. Goldman and F. Jackson and M. Kaye and Knoper, {Steven R} and A. Kotch and Kreitzer, {S. M.} and R. Lapidus and Miller, {H. C.} and Miller, {K. S.} and Nicotra, {M. B.} and B. Pichurko and Rice, {K. L.} and A. Ries and J. Sokolowski and J. Taylor and J. Tita and Tonner, {M. P.} and B. Votteri and Wachtel, {A. S.} and Weiss, {L. A.} and L. Wesselius and J. Westerman",
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T1 - Ipratropium bromide hydrofluoroalkane inhalation aerosol is safe and effective in patients with COPD

AU - Taylor, J.

AU - Kotch, A.

AU - Rice, K.

AU - Ghafouri, M.

AU - Kurland, C. L.

AU - Fagan, N. M.

AU - Witek T.J., Jr

AU - Allen, R.

AU - Amgott, T.

AU - Blumberg, H.

AU - Brazinsky, S. A.

AU - Castle, J. R.

AU - Costantini, P. J.

AU - Ellison, W. T.

AU - Garcia, Joe GN

AU - Garland, W. T.

AU - Goldman, M.

AU - Jackson, F.

AU - Kaye, M.

AU - Knoper, Steven R

AU - Kotch, A.

AU - Kreitzer, S. M.

AU - Lapidus, R.

AU - Miller, H. C.

AU - Miller, K. S.

AU - Nicotra, M. B.

AU - Pichurko, B.

AU - Rice, K. L.

AU - Ries, A.

AU - Sokolowski, J.

AU - Taylor, J.

AU - Tita, J.

AU - Tonner, M. P.

AU - Votteri, B.

AU - Wachtel, A. S.

AU - Weiss, L. A.

AU - Wesselius, L.

AU - Westerman, J.

PY - 2001

Y1 - 2001

N2 - 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.

AB - 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.

KW - Chlorofluorocarbon

KW - COPD

KW - Hydrofluoroalkane-134a

KW - Ipratropium bromide

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