Formoterol and beclomethasone versus higher dose beclomethasone as maintenance therapy in adult asthma

A total of 132 adult asthmatics who were symptomatic on 500 mg.day(-1) inha led beclomethasone dipropionate (BDP) were studied in an open-label randomi zed, parallel group, 12 week, clinical trial. The addition of 12 mg formoterol fumarate solution aerosol (pressurized met ered dose inhaler) b.i.d. to BDP at a dose of 500 mg.day(-1) was compared w ith a higher dose of 1,000 mg.day(-1) BDP, Mean morning premedication peak expiratory flow rate (PEF) during the final week of treatment (primary end-point) increased in both groups compared to baseline, The estimated treatment difference of 20.4 L.min(-1) (95% confid ence interval 3.2-37.6) after 12 weeks of treatment was statistically signi ficant (p<0.05) in favour of the formoterol/BDP group. The overall mean mor ning premedication PEF for the entire treatment period was higher in the fo rmaterol/BDP group (p=0.002), The overall number of puffs of rescue medicat ion and asthma symptom scores were less in the formoterol/BDP group (p<0.01 ). Safety and tolerability evaluations were satisfactory in both groups. In conclusion, the results suggest that the addition of formoterol fumarate to the existing dose of an inhaled corticosteroid should be considered as an alternative to increasing the dose of inhaled corticosteroid in the inad equately controlled asthmatic.