COMPARISON OF A NOVEL SALBUTAMOL MULTIDOSE POWDER INHALER WITH A SALBUTAMOL METERED-DOSE INHALER IN PATIENTS WITH ASTHMA

One hundred fifteen adult patients with asthma participated in this op en-label, randomized, parallel-group study that compared the acceptabi lity, clinical efficacy, and tolerability of salbutamol inhalation aer osol and powder in the treatment of asthma. There were no significant differences between groups in terms of demographic variables. Before t he study the patients had used inhaled steroids at least for 6 months and had shown an improvement in forced expiratory volume in 1 second ( FEV1) or in peak expiratory flow rate (PEFR) of more than 15% after th e inhalation of 200 mu g of salbutamol. The treatment period was 12 we eks and was preceded by a 2-week run-in period. The medications were d elivered from a metered dose inhaler (MDI) and from a new multidose po wder inhaler (MDPI). During the study, home PEFR was measured daily in the mornings and in the evenings. In the mornings PEFR was measured b oth before and 15 minutes after the inhalation of 200 mu g of salbutam ol. FEV1 and forced vital capacity (FVC) were measured after the run-i n period and after 4 and 12 weeks of treatment. FEV1 and FVC were meas ured immediately before and 15 and 30 minutes after the inhalation of 200 mu g of salbutamol. Asthma symptom scores, adverse events, and the use of rescue medication were recorded daily. Patients' preference of the inhalers (acceptability) was evaluated during the study after 4 w eeks of treatment. No significant differences were found between the t reatments in any of the efficacy variables measured. Of the 77 patient s allocated to use the new MDPI, 72 gave their opinion about the inhal ers: 34 patients (47%) rated MDPI easier to use than the MDI; 28 (39%) did not find any differences in handling between the two devices; and 10 (14%) felt the MDPI was more difficult to use than the MDI. We con clude that the new MDPI is clinically equivalent to the MDI in the lon g-term treatment of asthma, and the patients found it easy to use.