Comparison of Hydrofluoroalkane-Beclomethasone Dipropionate AutohalerTM with Budesonide TurbuhalerTM in Asthma Control

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Abstract
Background: Hydrofluoroalkane-beclomethasone dipropionate AutohalerTM (HFA-BDP AH) is a breath-actuated chlorofluorocarbon (CFC)-free metered dose inhaler in which BDP is in a solution of HFA propellant. Budesonide TurbuhalerTM (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 µg day–1, or an equivalent. After 5–14 days’ run-in, patients were randomized to HFA-BDP AH 800 µg day–1 or BUD TH 1,600 µg 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 (–∞, 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 FEV1 or β-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 µg day–1 provided control of moderate-to-severe asthma with efficacy and safety at least similar to BUD TH 1,600 µg day–1.