Therapeutic Equivalence and Acceptability of Two Multidose Powder Inhalers in the Treatment of Asthma

Abstract

Background: Problems in using conventional inhalation aerosols, in addition to environmental reasons, have driven development of the dry powder inhalers. Objective: To compare therapeutic equivalence and acceptability of two dry powder inhalers, Easyhaler (EH) and Diskhaler (DH), in the delivery of beclomethasone dipropionate (BDP) in the treatment of asthma. Methods: Adult asthmatics (n = 185), previously treated with inhaled steroids, were recruited in this open parallel-group study. After a run-in period of 2 weeks during which the patients inhaled 800 μg/day of BDP via DH, the patients were randomly allocated into three groups: EH 200 group (62 patients) using EH 200 μg/dose inhaler (1 inhalation q.i.d.), EH 400 group (62 patients) using EH 400 μg/dose inhaler (1 inhalation b.i.d.), and DH group (61 patients) using DH 200 μg/dose inhaler (1 inhalation q.i.d.) for 12 weeks. The primary outcome variables were PEF and FEV₁. Results: The 95% CI for treatment difference in morning PEF between the EH 200 and DH groups was –16 to 23 litres/min and between the EH 400 and DH groups –18 to 21 litres/min. There was an increase in the morning PEF of 13 litres/min (p < 0.05) in the EH 200 group, and 9 and 11 litres/min in the DH and EH 400 groups. No differences between the groups were seen in the lung function parameters, in the symptom scores, in the use of rescue medication or in the incidence of adverse events. The treatments had no effects on morning cortisol levels. The patients in the EH groups compared the inhalers by using an 11-item questionnaire. In 8 questions the majority of the patients rated EH superior to DH. Conclusion: The tested inhalers were therapeutically equal. However, based on the acceptability data, the EH was better accepted by the patients than DH.

Clinical Equivalence Trial on Budesonide Delivered either by the Novolizer^® Multidose Dry Powder Inhaler or the Turbuhaler^® in Asthmatic Patients

“…In fact, the improvements were seen not only in the subset of GCS naïves, but also in the subset of GCS-pre-treated patients. However, the degree of improvements observed in our GCS-pre-treated patients is very similar to that observed in the 5 studies in GCS-pre-treated patients [16, 17, 18, 19, 20, 21]. …”

“…We identified 6 studies that were similar in their objectives and design to our study: 3 studies compared a hydrofluoroalkane (HFA) propellant fluticasone device with a CFC device [16, 17, 18], 1 study compared an HFA propellant BDP device with a CFC device [19], and 2 studies compared two powder devices of BDP [20, 21]. Our study is about in the middle of the extremes with regard to sample size and duration of observation.…”

Do patients show the same level of adherence with all dry powder inhalers?

“…Patients vary in their preference for different dry powder inhalers, as shown in numerous studies of patient attitudes (Tables 2 and 3)(24–36). These findings suggest that patients do not see different devices as interchangeable.…”

Dosing powder inhaler Turbuhaler, its characteristics and a place among other inhalation devices

“…Такой фактор, как наличие цифрового счетчика доз, также значительно облегчает исполь зование ДПИ и улучшает комплаенс больных к ин галяционной терапии [48,49].…”