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Abstract
An open cross-over and randomized study was carried out in order to compare the efficacy and safety of inhaled salbutamol delivered from a new 50 μ g dose−1metered-dose dry powder inhaler Taifun®, and a commercially available 50 μ g dose−1dry powder inhaler Turbuhaler®, and a conventional 100 μ g dose−1pressurized metered-dose inhaler with a spacer (pMDI+S). Twenty-one patients, aged 21–70 years, with stable asthma and with demonstrated reversibility upon inhalation of salbutamol were included in the study. On three separate study days, the patients received a total dose of 400μ g of salbutamol from the dry powder inhalers and a dose of 800 μ g from the pMDI+S in a cumulative fashion: 1, 1, 2 and 4 doses at 30 min intervals. The per cent change in forced expiratory volume in 1 sec (FEV1), was used as the primary efficacy variable. Salbutamol inhaled via the Taifun®produced greater bronchodilation than the other devices. The difference in percent change in FEV1between the Taifun®and the other devices was statistically significant at the two first dose levels, but diminished towards the higher doses when the plateau of the dose–response curve was reached. The estimated relative dose potency of the Taifun®was approximately 1·9- and 2·8-fold compared to the Turbuhaler®and the pMDI+S, respectively. The Taifun®caused a slight, but clinically insignificant, decrease in serum potassium concentration. There were no significant changes in the other safety parameters (blood pressure, heart rate and electrocardiogram recordings) with any of the used devices. In conclusion, this study indicates that salbutamol inhaled via the Taifun®is more potent than salbutamol inhaled from the other devices tested. In practise, a smaller total dose of salbutamol from the Taifun®is needed to produce a similar bronchodilatory response. All treatments were equally well tolerated.
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References
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Article info
Publication history
Accepted:
July 13,
2001
Received:
January 8,
2001
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© 2001 Harcourt Publishers Ltd. Published by Elsevier Inc.
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