Hydrofluoroalkane-134a beclomethasone dipropionate, 400 microg, is as effective as chlorofluorocarbon beclomethasone dipropionate, 800 microg, for the treatment of moderate asthma

Chest. 1999 Feb;115(2):343-51. doi: 10.1378/chest.115.2.343.


Objective: The improved lung deposition of hydrofluoroalkane-134a beclomethasone dipropionate (HFA-BDP) extrafine aerosol compared with chlorofluorocarbon beclomethasone dipropionate (CFC-BDP) suggests that lower doses of HFA-BDP may be required to provide equivalent asthma control. The present study was undertaken to test this hypothesis.

Design: A 10- to 12-day run-in period confirmed that patients met established criteria of at least moderate asthma and the asthma was inadequately controlled by current therapy (inhaled beta-agonist and CFC-BDP [< or = 400 microg/d]). A short course of oral prednisone, 30 mg/d for 7 to 12 days, was followed to establish the patients were steroid responsive and to provide an "in-study" baseline of "optimal" asthma control.

Patients: A total of 347 patients were then randomized to HFA-BDP 400 microg/d, CFC-BDP 800 microg/d, or HFA-placebo for 12 weeks.

Results: Morning peak expiratory flow (AM PEF) measurements showed that HFA-BDP 400 microg/d achieved equivalent control of asthma to CFC-BDP 800 microg/d at all time intervals after oral steroid treatment. All other efficacy variables supported the AM PEF results and both active treatments were more effective than placebo. The safety profile of HFA-BDP compared favorably with that of CFC-BDP with no unexpected adverse events reported.

Conclusions: These findings demonstrate that HFA-BDP provides equivalent control of moderate or moderately severe asthma as CFC-BDP in the population studied, but at half the total daily dose.

Publication types

  • Clinical Trial
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Aerosols
  • Anti-Asthmatic Agents / administration & dosage*
  • Asthma / drug therapy*
  • Asthma / physiopathology
  • Beclomethasone / administration & dosage*
  • Chlorofluorocarbons
  • Double-Blind Method
  • Drug Combinations
  • Female
  • Glucocorticoids / administration & dosage*
  • Humans
  • Hydrocarbons, Fluorinated / administration & dosage*
  • Male
  • Peak Expiratory Flow Rate
  • Treatment Outcome


  • Aerosols
  • Anti-Asthmatic Agents
  • Chlorofluorocarbons
  • Drug Combinations
  • Glucocorticoids
  • Hydrocarbons, Fluorinated
  • Beclomethasone
  • apaflurane