COMPARISON OF A MULTIDOSE POWDER INHALER CONTAINING BECLOMETHASONE DIPROPIONATE (BDP) WITH A BDP METERED-DOSE INHALER WITH SPACER IN THE TREATMENT OF ASTHMATIC-PATIENTS

Objective: The clinical efficacy, tolerability and acceptability of a new multidose powder inhaler (MDPI) [Easyhaler(R), Orion Pharma, Finla nd] containing a high dose (500 mu g/dose) of beclomethasone dipropion ate (BDP) were compared with those of BDP metered dose inhaler adminis tered with a large volume spacer (MDI-spacer). Patients and Study Desi gn: Recruited patients were adult asthmatics currently receiving 800 t o 1000 mu g/day of inhaled corticosteroid. The dose of BDP during the study was 1000 mu g/day. The study was an open, randomised, parallel-g roup multicentre study and included a 2-week run-in period followed by a 12-week treatment period. Results: 74 patients were randomised to b oth groups. During the run-in period the mean morning peak expiratory flow (PEF) was 489 and 478 L/min in the MDPI and MDI-spacer groups, re spectively. During the last 2 weeks of the study the morning PEF was 4 85 L/min in the MDPI group and 477 L/min in the MDI-spacer group. Asth ma symptom scores and use of rescue medication were low in both groups . The median dose of histamine required to decrease forced expiratory volume in 1 second (FEV1) by 15% was 1.05mg in the MDPI group and 0.64 mg in the MDI-spacer group. The most frequent adverse events were hoar seness and sore throat. Mean serum cortisol levels were not affected i n either treatment group. Patients' personal opinion regarding accepta bility of the devices clearly favoured the MDPI. Conclusion: In conclu sion, the novel powder inhaler was well tolerated and at least equally effective compared with the conventional MDI-spacer combination in th e treatment of asthma with BDP. However, in everyday use the patients clearly favoured the powder inhaler.