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From the Department of Clinical Epidemiology and Biostatistics (Prof. Juniper), McMaster University Medical Centre, Ontario, Canada; and the Department of Pulmonary and Critical Care Medicine (Dr. Buist), Oregon Health Sciences University Hospital, Portland, OR.
A complete list of participants is located in the Appendix.
Correspondence to: Elizabeth F. Juniper, MCSP, MSc, Clinical Epidemiology and Biostatistics, McMaster University Medical Centre, 1200 Main Street West, Hamilton, Ontario L8S 3Z5, Canada
Objective: To compare the effect of hydrofluoroalkane-134a (HFA) beclomethasone dipropionate (BDP; 400 µg/d) with that of chlorofluorocarbon (CFC) BDP (800 µg/d) on asthma health-related quality of life in a 12-week, parallel-group, multicenter study.
Background: HFA-BDP is a new CFC-free preparation of BDP, which was developed as a result of CFCs being phased out from metered dose inhalers.
Methods: Following 7 to 12 days of prednisone, 30 mg/d, 347 adults with moderate asthma were randomized to receive either 400 µg/d HFA-BDP, 800 µg/d CFC-BDP, or HFA placebo for 12 weeks (all other oral and inhaled steroids were withdrawn). Patients completed the Asthma Quality of Life Questionnaire (AQLQ), and clinical asthma status was measured at the end of a run-in period, at randomization (after oral steroid treatment), and at the end of the study treatment.
Results: Sixty-one patients withdrew, 43 due to worsening
asthma (33 placebo; 5 HFA-BDP; 5 CFC-BDP). There was a deterioration in
the AQLQ score (- 0.81) in the placebo group, and the difference
between this and the stability observed in both the HFA-BDP group
(+ 0.13) and the CFC-BDP group (- 0.03) was statistically
significant (p
0.003). The difference between the two
active treatments was not significant (p = 0.290). The calculated
number of patients who needed to be treated in order to see a benefit
in one patient (with the placebo as the standard treatment) was 2.4 for
HFA-BDP and 3.0 for CFC-BDP. Only weak to moderate correlations
were observed between changes in AQLQ scores and between asthma
clinical status measures.
Conclusion: HFA-BDP (400 µg/d) was as effective as CFC-BDP (800 µg/d) in sustaining improvements in asthma quality of life following withdrawal of 7 to 12 days of prednisone treatment in moderate asthma.
Key Words: asthma beclomethasone dipropionate chlorofluorocarbon hydrofluoroalkane quality of life
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