Clinical Trials
Since Provocholine is a diagnostic agent, there is great value to including methacholine challenge testing as part of clinical trial protocols. It can have a variety of applications depending on the question that is being asked.
Methapharm has experience providing technical support for clinical trials using Provocholine in the following areas:
- Study inclusion/exclusion criteria
- Bioequivalence
- Quantifying a response to investigational medications
- Comparing inhaler devices
- Epidemiological studies
- Specific atopies (allergies)
- Consumer product evaluation
The FDA have issued two guidance’s where methacholine challenge testing is discussed specifically when used in clinical trials: