Int. Journal of Clinical Pharmacology and Therapeutics, Volume 44 - January (27 - 30)

Methacholine challenge tests: sample sizes required in crossover trials
M. Neuhäuser, K.-H. Jöckel
Institute for Medical Informatics, Biometry and Epidemiology, University Hospital Essen, Germany

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DOI 10.5414/CPP44027

Abstract

Objective: Methacholine challenge testing is common for assessing the pharmacodynamic properties of anti-asthma drugs. In order to design studies and to interpret published studies, sample size calculations are essential. Unfortunately, wrong sample sizes were previously reported in the literature. We present correct sample sizes required for the comparison of two treatments based on methacholine challenge testing in a crossover study. Methods and results: Formulas for sample size calculations and the resulting number of subjects required for a specified power are presented for studies designed to show a difference as well as for equivalence and non-inferiority studies. Conclusions: A much larger sample size is required for methacholine challenge testing than previously reported.

Author Details

Authors

Departments

  • Institute for Medical Informatics, Biometry and Epidemiology, University Hospital Essen, Germany

Address

M. Neuhäuser
Institute for Medical Informatics, Biometry and Epidemiology
University Hospital Essen
Hufelandstraße 55
45122 Essen, Germany
Email: [email protected]

Citation

M. Neuhäuser and K.-H. Jöckel.Methacholine challenge tests: sample sizes required in crossover trials. 2006; 44: 27-30. doi: 10.5414/CPP44027.

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