Related Experiment Video
Updated: Aug 13, 2026

A Clinical Trial Assessing the Safety, Efficacy, and Delivery of Olive-Oil-Based Three-Chamber Bags for Parenteral Nutrition
Published on: September 20, 2019
Methacholine challenge tests: sample sizes required in crossover trials
1Institute for Medical Informatics, Biometry and Epidemiology, University Hospital Essen, Germany. markus.neuhaeuser@medizin.uni-essen.de
Accurate sample size calculations are crucial for methacholine challenge testing in asthma drug studies. This research provides correct sample sizes, revealing significantly larger requirements than previously reported.
Area of Science:
- Pharmacology and Clinical Trial Design
- Respiratory Medicine and Asthma Research
Background:
- Methacholine challenge testing is a standard method for evaluating the pharmacodynamic effects of asthma medications.
- Accurate sample size calculations are vital for the robust design and interpretation of clinical studies.
- Previous literature has reported incorrect sample size estimations for methacholine challenge studies.
Purpose of the Study:
- To present accurate sample size calculations for comparing two treatments using methacholine challenge testing.
- To provide correct sample size requirements for crossover study designs.
- To address and correct erroneous sample size figures previously published.
Main Methods:
- Development of formulas for sample size calculations.
- Presentation of required subject numbers for specified statistical power.
- Inclusion of calculations for difference, equivalence, and non-inferiority study designs.
Main Results:
- Formulas and subject numbers are provided for various study designs.
- The calculations demonstrate the sample size needed to achieve desired statistical power.
Conclusions:
- Methacholine challenge testing necessitates a substantially larger sample size than previously understood.
- The findings underscore the importance of using correct sample size calculations for reliable study outcomes.
Related Concept Videos
Crossover Experiments
Crossover designs are performed even with smaller sample sizes since the samples can act as their controls. These are better than simple randomized trials since patients are exposed to all the treatments.
Multiple Comparison Tests
It would be easy to compare two samples using a significance alpha level of 0.05. In other words, there is only one sample pair to be compared. However, it would be difficult to identify a significantly different sample if the number...
McNemar's Test
Cochran's Q Test
Test for Homogeneity
Testing a Claim about Population Proportion
There are two methods of testing a claim about a population proportion: (1) Using the sample proportion from the data where a binomial distribution is approximated to the normal distribution and (2) Using the binomial probabilities calculated from the data.
The first method uses normal distribution as an approximation to the binomial distribution. The requirements are as follows: sample size is large...

