Equivalent asthma control after dose reduction with HFA-134a beclomethasone solution aerosol. Comparative Inhaled Steroid Investigation Group (CISIG).
OBJECTIVE
The replacement of chlorofluorocarbon (CFC) by hydrofluoroalkane has the potential to improve airway deposition of BDP. We investigated whether HFA-BDP extra-fine solution aerosol 400 microg day(-1) is as effective as CFC-BDP 1000 micro day(-1) in patients with stable, moderate asthma, having persistent bronchial hyperresponsiveness.


METHODS
One hundred and fifty patients with moderate asthma from 20 centres, on inhaled steroids for < or = 3 months, entered a 4-week run-in period with 1000 microg day(-1) CFC-BDP. Patients were then allocated to a 10-week study phase, receiving CFC-BDP 1000 microg day(-1) or HFA-BDP 400 microg day(-1). Symptom score and PEF were measured daily and recorded as biweekly means. Spirometry, PC20FEV1, blood eosinophils and serum ECP were determined on days 15, 29, 43 and 71, and compared to the last visit of the run-in period. All group members were trained in a quality control centre.


RESULTS
Treating the population of the HFA-BDP group (n = 72) and the CFC-BDP group (n = 78) did not show significant differences in terms of symptoms, lung function, airway hyperresponsiveness and serum markers of inflammation at the end of the run-in period and the end of the study phase.


CONCLUSIONS
Using HFA instead of a CFC metered dose inhaler, containing less than half the daily dose of BDP, allows control of symptoms and lung function parameters, without changes in bronchial hyperresponsiveness.
Krankenhaus Grosshansdorf, Zentrum für Pneumologie und Thoraxchirurgie, Germany. magnussen@pulmoresearch.de
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D000280:Administration, Inhalation; D000293:Adolescent; D000328:Adult; D000368:Aged; D018927:Anti-Asthmatic Agents / Q000008:administration & dosage*; D001249:Asthma / Q000188:drug therapy* / Q000503:physiopathology; D001507:Beclomethasone / Q000008:administration & dosage*; D017402:Chlorofluorocarbons; D004311:Double-Blind Method; D005260:Female; D005541:Forced Expiratory Volume / Q000187:drug effects; D006801:Humans; D006845:Hydrocarbons, Fluorinated / Q000008:administration & dosage*; D008297:Male; D008875:Middle Aged; D010349:Patient Compliance; D010366:Peak Expiratory Flow Rate / Q000187:drug effects; D015203:Reproducibility of Results; D005466:Fluorocarbons
D018927:Anti-Asthmatic Agents; D001507:Beclomethasone; D017402:Chlorofluorocarbons; D006845:Hydrocarbons, Fluorinated; C094049:apaflurane; D005466:Fluorocarbons