Long-term safety of flunisolide hydrofluoroalkane metered-dose inhaler in adults and adolescents with asthma

Objective: To determine the long-term safety of flunisolide hydrofluoroalkane (HFA) in adults and adolescents with mild-to-moderate asthma. Design and Setting: A 1-year multicentre, randomised, open-label, parallel-group study was conducted at 24 centres in the United States. Patients: A total of 215 male or female patients aged 12 to 60 years with mild-to-moderate asthma were eligible to enter the 52-week open-label phase. Intervention: Eligible patients were randomly assigned in a 3:1 ratio to receive inhaled flunisolide (85 mug per puff) or beclomethasone dipropionate chlorofluorocarbon (BDP CFC) [84 mug per puff] as an active control. Results: The incidence of adverse events was comparable in the flunisolide HFA (n = 162) and BDP (n = 53) groups; most were mild or moderate and considered unrelated to treatment. The flunisolide HFA group reported fewer respiratory complaints and had a significantly lower incidence of sinusitis (14.2 vs 26.4%, p = 0.04). No clinically important differences were observed for physical or laboratory parameters. The flunisolide HFA group had consistently fewer positive smears and cultures for Candida albicans, as well as a consistently lower incidence of candidiasis. Thrush infection occurred almost eight times more frequently in the BDP group (9.4 vs 1.2% for flunisolide HFA, p = 0.004). Conclusions: Flunisolide HFA, at one-third the daily dose (median daily dose of 340 mug) of flunisolide CFC, was well tolerated and effective when administered to adult and adolescent patients with mild-to-moderate asthma.