Initial treatment of symptomatic mild to moderate bronchial asthma with the salmeterol/fluticasone propionate (50/250 microg) combination product (SAS 40023).

BACKGROUND: Chronic controller therapy, particularly with inhaled corticosteroids, is required in patients with persistent bronchial asthma. Long-acting beta agonists provide prolonged bronchodilatation, improve symptoms and reduce exacerbations. A powder inhaler containing both fluticasone propionate and salmeterol xinafoate combines anti-inflammatory treatment and bronchodilatation in a single user-friendly device (Diskus).

OBJECTIVE: The goal of the present study was to evaluate the efficacy and safety of salmeterol/ fluticasone (50/250 microg twice daily) as initial treatment for symptomatic patients with mild to moderate bronchial asthma who had not previously received appropriate anti-asthma medication.

METHODS: This prospective study was conducted in 17 study centres located predominantly in private practices. 127 patients with mild to moderate asthma (FEV(1) >60% of predicted) aged 12 years and older were recruited into a one-week screening phase. If they used rescue medication on > or =3 of 7 days or had a total asthma symptom score of > or =5 points, they were admitted to the treatment phase and received salmeterol xinafoate (50 microg) and fluticasone propionate (250 microg) in a single dry powder inhaler (Diskus) for four weeks.

RESULTS: Combined salmeterol/fluticasone therapy improved morning and evening peak expiratory flow rates (PEFR) as measured by patients and reported in asthma diaries within the first week of treatment (by 35 and 28 L/min, respectively). At week 4, morning PEFR had increased by 57 L/min or 13.0 % predicted compared to baseline, and forced expiratory volume in one second (FEV1) had improved by 12.5% of predicted (p<0.001). Use of rescue medication declined by 1.9 puffs per day. Both patients and physicians regarded treatment as a major benefit: two thirds assessed treatment as "excellent". The combination was well tolerated.

CONCLUSIONS: The combined inhalation of salmeterol and fluticasone from a single dry powder inhaler (DiskuS) was an effective initial treatment for patients with mild to moderate asthma. Improvements of symptoms and lung function were documented by the first week of treatment. This combination provides rapid and effective asthma control that is highly acceptable to both the patient and physician.