Comparison of hydrofluoroalkane-beclomethasone dipropionate autohaler™ with budesonide turbuhaler™ in asthma control

Background. Hydrofluoroalkane-beclomethasone dipropionate Autohaler (TM) (HFA-BDP AH) is a breath-actuated chlorofluorocarbon (CFC)-free metered dose inhaler in which BDP is in a solution of HFA propellant. Budesonide Turbuhaler (TM) (BUD TH) is a breath-dependent dry powder inhaler. Objectives: To test the hypothesis that half the daily dose of HFA-BDP AH would provide an equivalent control of asthma symptoms to the BUD TH. Methods: This was an 8-week open study in patients with symptomatic moderate-to-severe asthma, previously on BUD 500-1,000 mug day(-1), or an equivalent. After 5-14 days' run-in, patients were randomized to HFA-BDP AH 800 mug day(-1) or BUD TH 1,600 mug day(-1). The intent-to-treat population consisted of 111 patients on HFA-BDP AH and 98 patients on BUD TH. Results., Mean change from baseline in PEF in the morning (AM PEF) at week 8 was 23.95 liters min(-1) for HFA-BDP AH and 24.46 liters min(-1) for BUD TH. A two-sided equivalence test using the 0.51 liter min(-1) difference gave 95% confidence intervals within a defined equivalence interval of (-infinity, 25 liters min(-1)) indicating that the mean change in AM PEF was equivalent for the two groups. There were no significant differences in the mean change from baseline in FEV, or P-agonist use. Patients using HFA-BDP AH had a significantly greater mean change from baseline in the percentage of days free from shortness of breath (p = 0.05), chest tightness (p = 0.02) and nights without sleep disturbance (p = 0.04) at week 3, and wheeze (p = 0.01), shortness of breath (p = 0.02), chest tightness (p < 0.01) and daily asthma symptoms (p = 0.03) at week 8. The incidence, type and severity of adverse events were similar in each group. At week 8, the mean change from baseline in corrected urine cortisol/creatinine ratio in a subgroup of patients was -0.36 for HFA-BDP and -4.88 for BUD TH (p < 0.01). Conclusions: HFA-BDP 800 pg day-1 provided control of moderate-to-severe asthma with efficacy and safety at least similar to BUD TH 1,600 pg day(-1). Copyright (C) 2001 S. Karger AG, Basel.