Safety and Efficacy of HFA-134a Beclomethasone Dipropionate Extra-Fine Aerosol over Six MonthsReport as inadecuate

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Canadian Respiratory Journal - Volume 11 2004, Issue 2, Pages 123-130

Original Article

Institut universitaire de cardiologie et de pneumologie, l’Université Laval, Hôpital Laval, Sainte-Foy, Quebec, Canada

Service de pneumologie, Hôpital du Sacré-Coeur, Montreal, Quebec, Canada

Hôpital Général de Montréal, Montreal, Quebec, Canada

Centre hospitalier universitaire de Sherbrooke, Sherbrooke, Quebec, Canada

Copyright © 2004 Hindawi Publishing Corporation. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.


OBJECTIVE: To compare the systemic safety and efficacy of hydrofluoroalkane beclomethasone dipropionate HFA-BDP extra-fine aerosol 800 µg-day with chlorofluorocarbon CFC-BDP 1500 µg-day.

DESIGN: Six-month, randomized, parallel-group, double-blind, double-dummy study.

PATIENTS: Patients n=141 with moderate to severe asthma adequately controlled by CFC-BDP 1000 µg-day to 2000 µg-day.

INTERVENTIONS: Patients received CFC-BDP 1500 µg-day during a two-week run-in period and were then randomized to either HFA-BDP n=70 or CFC-BDP n=71.

RESULTS: Similar proportions of HFA-BDP and CFC-BDP patients had a 24 h urinary free cortisol values below the reference range at month 6 15% versus 25%, P=0.35. Measures of adrenocorticotrophic hormone stimulation and morning plasma cortisol levels were also similar in each group. The frequency of skin bruising and oral candidiasis was low for both treatments. No change in intraocular pressure was reported for either treatment. Pulmonary function was similar in both groups; however, the onset of the first asthma exacerbation or increased asthma symptoms tended to be earlier for CFC-BDP than for HFA-BDP P=0.076; 27% of CFC-BDP patients reported increased asthma symptoms, compared with 14% of HFA-BDP patients P=0.095.

CONCLUSIONS: HFA-BDP 800 µg-day has a systemic adverse event profile comparable to that of CFC-BDP 1500 µg-day, and further control of asthma symptoms may be achieved after a switch from CFC-BDP 1500 µg-day to HFA-BDP 800 µg-day.

Author: Louis-Philippe Boulet, André Cartier, Pierre Ernst, Pierre Larivée, and Michel Laviolette



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