Objective: To compare the effect of
hydrofluoroalkane-134a (HFA) beclomethasone dipropionate (BDP; 400μ
g/d) with that of chlorofluorocarbon (CFC) BDP (800 μg/d) on
asthma health-related quality of life in a 12-week, parallel-group,
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 400μ
g/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other oral and inhaled steroids were withdrawn).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 (400μ
g/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.