Health-related quality of life in moderate asthma: 400 microg hydrofluoroalkane beclomethasone dipropionate vs 800 microg chlorofluorocarbon beclomethasone dipropionate. The Study Group.

OBJECTIVE

To compare the effect of hydrofluoroalkane-134a (HFA) beclomethasone dipropionate (BDP; 400 microg/d) with that of chlorofluorocarbon (CFC) BDP (800 microg/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400 microg/d HFA-BDP, 800 microg/d CFC-BDP, or HFA placebo for 12 weeks (all other oral and inhaled steroids were withdrawn).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 microg/d) was as effective as CFC-BDP (800 microg/d) in sustaining improvements in asthma quality of life following withdrawal of 7 to 12 days of prednisone treatment in moderate asthma.