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


METHODS
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.


METHODS
Thirty-one clinical centers in the United States participated in this project.


METHODS
A total of 507 patients with moderate-to-severe COPD were randomized, and 444 patients completed the trial.


METHODS
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.


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.
Taylor
J
J
Clinical Research, Boehringer Ingelheim Pharmaceuticals, Ridgefield, CT 06877-0368, USA.
Kotch
A
A
Rice
K
K
Ghafouri
M
M
Kurland
C L
CL
Fagan
N M
NM
Witek
T J
TJ
D000328:Adult; D000335:Aerosol Propellants / Q000008:administration & dosage; D000368:Aged; D000369:Aged, 80 and over; D000403:Airway Resistance / Q000187:drug effects; D017402:Chlorofluorocarbons / Q000009:adverse effects; D004311:Double-Blind Method; D005260:Female; D005541:Forced Expiratory Volume / Q000187:drug effects; D006801:Humans; D006845:Hydrocarbons, Fluorinated / Q000009:adverse effects; D009241:Ipratropium / Q000008:administration & dosage* / Q000009:adverse effects; D008297:Male; D008875:Middle Aged; D009330:Nebulizers and Vaporizers; D005466:Fluorocarbons
D000335:Aerosol Propellants; D017402:Chlorofluorocarbons; D006845:Hydrocarbons, Fluorinated; D009241:Ipratropium; C094049:apaflurane; D005466:Fluorocarbons