Safety, tolerability and acceptability of two dry powder inhalers in the administration of budesonide in steroid-treated asthmatic patients.

The purpose of this randomized, double-blind parallel group study was to compare the safety, tolerability and acceptability of Easyhaler and Turbuhaler dry powder inhalers for the delivery of budesonide 800 microg day(-1) in adult asthmatic patients who had already been treated with inhaled corticosteroids for at least 6 months prior to the study Additionally the efficacy of the products was evaluated. The main objective was to evaluate the systemic safety of budesonide inhaled from Easyhaler (Giona Easyhaler, Orion Pharma, Finland) as determined by serum and urine cortisol measurements. The secondary objective was to compare the tolerability acceptability and efficacy of the two devices in the administration of budesonide. After a 2-week run-in period (baseline), patients were randomized on a 2:1 basis to receive budesonide from Easyhaler (n = 103) or from Turbuhaler (Pulmicort Turbuhaler, AstraZeneca, Sweden) (n = 58) 200 g dose(-1), two inhalations twice daily for 12 weeks. There was no statistically significant change in morning serum cortisol values from baseline to the end of treatment in either group. Urine free cortisol and urine cortisol/ creatinine ratio increased from baseline in both groups. There were no significant differences between the groups in terms of morning serum cortisol, urine cortisol, adverse events or efficacy variables, but Easyhaler was generally considered more acceptable to the patients. In conclusion, at 800 microg day(-1), Giona Easyhaler is as safe and efficacious as Pulmicort Turbuhaler in adult asthmatic patients previously treated with corticosteroids, but more acceptable to patients.

Salbutamol via Easyhaler is at least as effective as salbutamol via Turbuhaler in the treatment of histamine-induced bronchoconstriction.

The aim of this study was to compare the clinical efficacy and acceptability of salbutamol inhaled via Easyhaler and Turbuhaler multi-dose dry powder inhalers in the treatment of histamine-induced bronchoconstriction. Thirty-two adult patients with asthma and/or bronchial hyper-reactivity were included in the study, which was carried out according to a randomized, double-blind, double-dummy, cross-over design. Histamine challenge test was performed on 2 study days separated by at least 7 days. The challenge test was continued until a > or = 20% fall in forced expiratory volume in 1 sec (FEV1) was achieved. The patients then inhaled a single 100 microg dose of salbutamol from Easyhaler, or from Turbuhaler. FEV1 was assessed by flow-volume spirometry before and after histamine challenge and 1.5, 3, 5, 10, 15, 20, 30 and 60 min after salbutamol inhalation. The primary efficacy variable was the maximum percentage change in FEV1 from the post-challenge value. The secondary efficacy variable was area under the curve (AUC) of FEV1. At the end of the study, acceptability of salbutamol Easyhaler was evaluated using a questionnaire and Easyhaler was also compared with the inhalation device the patient had used earlier. Twenty-six patients completed the study. Both salbutamol Easyhaler and salbutamol Turbuhaler produced a rapid and significant increase in FEV1, with maximum percentage changes being 43.9% (+/-15.3) and 40.5% (+/-21.9) from the post-challenge value, respectively. There were no significant differences between the two inhalation devices in terms of changes in FEV1 or AUC of FEV1. The use of Easyhaler and getting a new dose from Easyhaler was considered to be very easy by 65% and easy by 35% of the patients. None considered it difficult. Of 16 patients who had used Turbuhaler earlier, 19% considered Easyhaler much better, 44% better, and 38% the same as Turbuhaler, and none considered it worse. In conclusion, the results show that salbutamol Easyhaler was at least as effective as salbutamol Turbuhaler in the treatment of histamine-induced bronchoconstriction. In addition, the patients considered Easyhaler very easy or easy to use. The majority of patients who reported Turbuhaler as their own inhaler considered Easyhaler better or much better than Turbuhaler.

Efficacy of salbutamol via Easyhaler unaffected by low inspiratory flow.

The fine particle dose delivered via dry powder inhalers (DPIs) is often affected by the inspiratory flow rate generated during inhalation. This has clinical implications, since the fine particle dose determines the amount of drug reaching the lungs. With Easyhaler DPI the fine particle dose remains relatively constant over the range of inspiratory flow rates from 30-60 l min(-1). The aim of this study was to confirm that clinical efficacy is maintained even at low flow rates by comparing the bronchodilating effect of salbutamol (100 microg) delivered via Easyhaler at a target inspiratory flow of 30 l min(-1) with the same dose of salbutamol via pressurised metered-dose inhaler (pMDI) plus spacer. This was a double-blind, randomized, cross-over study with double-dummy technique. Twenty-one paediatric and adult asthmatic patients completed the study, which was conducted over 2 study days. The main outcome parameter was forced expiratory volume in 1 sec (FEV1). The patients were trained to generate a low peak inspiratory flow rate (PIFR) of 30 l min(-1), and the actual PIFR through Easyhaler was recorded. The average PIFR through Easyhaler was 28.7 l min(-1). The difference in the maximum value of FEV1 (FEV1max) between the treatments after drug inhalation was 0.01 l. The mean of FEV1max was 2.67 l after pMDI plus spacer compared to 2.69 l after Easyhaler. Improvements in FEV1 were clinically significant. No significant differences between treatments were found. A reasonably low inspiratory flow rate through Easyhaler produces an equivalent improvement in lung function to a correctly used pMDI plus spacer. Hence, Easyhaler can be used with confidence in patients who may have difficulty in generating a high inspiratory flow rate, such as children and the elderly.