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European Journal of Clinical Pharmacology

, Volume 39, Issue 3, pp 281–285 | Cite as

Comparison of the efficacy and systemic effects of 4 mg and 8 mg formulations of salbutamol controlled release in patients with asthma

  • B. J. Lipworth
  • R. A. Clark
  • D. P. Dhillon
  • J. B. D. Palmer
  • D. G. McDevitt
Originals

Summary

The purpose of the present study was to compare the efficacy and systemic effects of 4 mg and 8 mg doses of salbutamol controlled release (SCR) after single dosing and at steady state in patients with asthma. Fifteen asthmatic patients (Age 36 y, FEV1 85% predicted) were given SCR 4 mg and 8 mg twice daily for 7 days in a randomised double-blind cross-over design, with at least 7 days washout between treatments.

There were no differences between the bronchodilator effects of 4 mg and 8 mg doses. There was no evidence of tolerance to the bronchodilator effects after chronic dosing. Morning and evening PEFR measurements also showed improvements during treatment with SCR 4 mg and SCR 8 mg, although there were no differences between the two formulations. Both doses of SCR caused significant objective tremor responses which were maintained after chronic dosing. The 8 mg dose produced a larger tremor response after single dosing, but not at steady-state. Subjective tremor occurred in 7 patients with SCR 8 mg, and in 2 patients with SCR 4 mg. There were no cardiac arrhythmias on Holter ECG monitoring.

These results suggest that the 8 mg dose of SCR was no more effective than the 4 mg formulation, and was associated with more systemic adverse effects.

Key words

salbutamol asthma beta-adrenoceptor controlled release formulation adverse effects 

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Copyright information

© Springer-Verlag 1990

Authors and Affiliations

  • B. J. Lipworth
    • 1
    • 2
  • R. A. Clark
    • 2
  • D. P. Dhillon
    • 2
  • J. B. D. Palmer
    • 3
  • D. G. McDevitt
    • 1
  1. 1.Department of Clinical PharmacologyNinewells Hospital and Medical SchoolDundeeUK
  2. 2.Department of Thoracic MedicineKing's Cross HospitalDundeeUK
  3. 3.Glaxo Group ResearchGreenfordUK

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