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Clinical Investigations: ASTHMA |

Hydrofluoroalkane-134a Beclomethasone Dipropionate, 400 μg, Is as Effective as Chlorofluorocarbon Beclomethasone Dipropionate, 800 μg, for the Treatment of Moderate Asthma*

Gary Gross, MD; Philip J. Thompson, MD, FCCP; Paul Chervinsky, MD; Jennifer Vanden Burgt, BS, BA; the Study Group
Author and Funding Information

*From the Dallas Allergy and Asthma Center (Dr. Gross), Dallas, TX; Asthma and Allergy Research Unit, Department of Medicine, University of Western Australia (Prof. Thompson), Perth, Australia; New England Clinical Studies (Dr. Chervinsky), North Dartmouth, MA; 3M Pharmaceuticals (Ms. Vanden Burgt), St. Paul, MN.

*From the Dallas Allergy and Asthma Center (Dr. Gross), Dallas, TX; Asthma and Allergy Research Unit, Department of Medicine, University of Western Australia (Prof. Thompson), Perth, Australia; New England Clinical Studies (Dr. Chervinsky), North Dartmouth, MA; 3M Pharmaceuticals (Ms. Vanden Burgt), St. Paul, MN.


*From the Dallas Allergy and Asthma Center (Dr. Gross), Dallas, TX; Asthma and Allergy Research Unit, Department of Medicine, University of Western Australia (Prof. Thompson), Perth, Australia; New England Clinical Studies (Dr. Chervinsky), North Dartmouth, MA; 3M Pharmaceuticals (Ms. Vanden Burgt), St. Paul, MN.


Chest. 1999;115(2):343-351. doi:10.1378/chest.115.2.343
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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 β-agonist and CFC-BDP [≤ 400 μg/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 μg/d, CFC-BDP 800 μg/d, or HFA-placebo for 12 weeks.

Results: Morning peak expiratory flow (am PEF) measurements showed that HFA-BDP 400 μg/d achieved equivalent control of asthma to CFC-BDP 800 μg/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.

Abbreviations: am PEF = morning peak expiratory flow; ANOVA = analysis of variance; BDP = beclomethasone dipropionate; CFC = chlorofluorocarbon; CI = confidence interval; HFA = hydrofluoroalkane-134a; MDI = metered-dose inhaler; pm PEF = evening peak expiratory flow

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