Multicentre, randomised, parallel-group study of the efficacy and tolerability of flunisolide administered once daily via AeroChamber® in the treatment of mild to moderate asthma

Objective: To evaluate the efficacy and tolerability of flunisolide given once-daily in patients with persistent asthma versus other inhaled corticosteroids given in standard multidose regimens. Patients and Methods: A total of 515 patients aged 16 to 75 years with mild to moderate asthma stabilised on multidose regimens of various inhaled corticosteroids were enrolled in an 8-week, open-label, multicentre, randomised, parallel-group study. Patients were randomised in a 4:1 ratio to receive either once-daily flunisolide (1000 mu g at 6pm increased if necessary up to 2000 mu g; n = 416) administered via AeroChamber(R) or their previous corticosteroid regimens (triamcinolone, beclomethasone or fluticasone propionate; n = 99), which were continued on a 2- to 4-times daily basis at the previously established dosages. The transfer to once-daily flunisolide from the previous regimen was made directly without a run-in period. Results: The treatment 'success rate' [percentage of patients whose forced expiratory volume in 1 second (FEV1) values at the study end-point were at least 90% of baseline values] was 85.7% in both treatment groups. Other efficacy parameters, including percentage predicted FEV1, morning and evening peak expiratory flow rate (PEFR) values, asthma symptom scores, salbutamol (albuterol) usage, nocturnal awakenings, quality-of-life scores and global rating of change were also similar in the two groups. The incidence of drug-related adverse events such as headache, increased cough, pharyngitis, nausea and oral candidiasis were low in both groups (less than or equal to 1.7% with flunisolide), and there were no notable changes in vital signs or physical examination variables in either group. The majority of patients expressed a preference for the once-daily flunisolide dosage regimen. Conclusions: Once-daily flunisolide provided asthma therapy that was at least as effective and as well tolerated as the patients' previous inhaled corticosteroid medication, indicating that individuals with mild to moderate asthma can be directly transferred to once-daily flunisolide therapy without compromising efficacy and tolerability.