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 FEV(1) 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 microg; ipratropium bromide HFA, 84 microg; HFA placebo; ipratropium bromide inhalation aerosol, 42 microg; or CFC placebo.

MEASUREMENTS AND RESULTS:

Patients in all active treatment groups had significant bronchodilator responses as shown by increases in mean FEV(1) from baseline of at least 15%. Bronchodilator response in all active treatment groups was also significantly more than their respective placebo treatments based on FEV(1), area under the time-response curve from 0 to 6 h, and peak response. FVC results were similar to those seen with FEV(1). There were no significant differences in adverse events, laboratory findings, or ECG findings among the treatment groups.

CONCLUSIONS:

Ipratropium bromide HFA, 42 and mgr;g, provided bronchodilation comparable to the marketed ipratropium bromide CFC, 42 and mgr;g, over 12 weeks of regular use.

• Authors: J Taylor, A Kotch, K Rice, M Ghafouri, C L Kurland, N M Fagan, T J Witek Jr, Ipratropium Bromide HFA Study Group
• Journal: Chest (Chest) Vol. 120 Issue 4 Pg. 1253-61 (Oct 2001) ISSN: 0012-3692 [Print] United States
• PMID: 11591569 (Publication Type: Clinical Trial, Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Aerosol Propellants
• Chlorofluorocarbons
• Hydrocarbons, Fluorinated
• Ipratropium
• apaflurane

Topics

• Adult
• Aerosol Propellants (administration & dosage)
• Aged
• Aged, 80 and over
• Airway Resistance (drug effects)
• Chlorofluorocarbons (adverse effects)
• Double-Blind Method
• Female
• Forced Expiratory Volume (drug effects)
• Humans
• Hydrocarbons, Fluorinated (adverse effects)
• Ipratropium (administration & dosage, adverse effects)
• Male
• Middle Aged
• Nebulizers and Vaporizers