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Salbutamol via Easyhaler® Produces Equivalent Bronchodilation to Terbutaline via Turbuhaler® following Inhalation of a Single Dose of Equipotent β2-Sympathomimetic

  • Clinical Pharmacodynamics
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Abstract

Objective: The aim of this study was to compare the bronchodilating effect, tolerability and acceptability of a single 100μg dose of salbutamol inhaled via Easyhaler® multidose dry powder inhaler with a single 250μg dose of terbutaline inhaled via Turbuhaler®, also a multidose dry powder inhaler.

Design, Setting and Patients: The study was conducted according to a single-dose, crossover, randomised, double-blind with double-dummy design in four centres in Finland. A total of 29 adult patients with stable asthma without previous experience with the tested devices completed the study, which comprised 2 study days with 4-hour follow-up periods including spirometric measurements. The acceptability of the devices to the patients in the study was also evaluated.

Results: The mean (SD) maximum value of forced expiratory volume in 1 second (FEV1max) after salbutamol Easyhaler® was 3.14L (1.26L), and after terbutaline Turbuhaler® was 3.07L(1.11L). The mean (SD) percentage change from baseline of forced expiratory volume in 1 second (FEV1) to FEV1max was 12.7% (12.4%) after Easyhaler® and 13.1% (10.8%) after Turbuhaler®. The observed differences in the increase in FEV1 and in the area under the curve (AUC) of FEV1 between the treatments were not statistically significant. Four patients reported mild adverse events after inhaling salbutamol via Easyhaler®, compared with five patients who reported adverse events after inhaling terbutaline via Turbuhaler®. Based on the VAS assessment of the acceptability, Easyhaler® was found to be better accepted than Turbuhaler® in terms of ease of administration, ease of inhaling, and the strength of sensation on receiving a dose. Overall, 62% of the patients would have chosen Easyhaler®.

Conclusions: Easyhaler® containing salbutamol (100μg/dose) is comparable in efficacy and as well tolerated as Turbuhaler® containing terbutaline (250μg/dose), and Easyhaler® was well accepted by patients.

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Acknowledgements

The authors wish to thank the participating investigators Dr T. Kava, Joensuu, Dr S. Krogerus, Kinkomaa, Dr M. Lehtiniemi, Joensuu, Dr L.-H. Pláthin, Harjavalta, Dr M. Pietiläinen, Harjavalta and Dr K. Venho, Kinkomaa for their valuable contribution to the study. This study was funded by Orion Pharma, Finland.

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Authors and Affiliations

  1. Orion Pharma, Easyhaler Project, Kuopio, Finland

    A. Malinen, T. Koskela & M. Silvasti

  2. Department of Respiratory Medicine, Tampere University Hospital, Tampere, Finland

    J. Hedman

  3. Orion Pharma, Biostatistics and Data Management, Kuopio, Finland

    P. Toivanen

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  1. A. Malinen
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  2. J. Hedman
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  3. T. Koskela
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  4. M. Silvasti
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  5. P. Toivanen
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Correspondence to A. Malinen.

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Malinen, A., Hedman, J., Koskela, T. et al. Salbutamol via Easyhaler® Produces Equivalent Bronchodilation to Terbutaline via Turbuhaler® following Inhalation of a Single Dose of Equipotent β2-Sympathomimetic. Clin. Drug Investig. 20, 165–171 (2000). https://doi.org/10.2165/00044011-200020030-00004

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  • DOI: https://doi.org/10.2165/00044011-200020030-00004

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