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 inclinical trials:

Research

Research on asthma and other respiratory conditions has evolved over the years. Provocholine is frequently used as the primary outcome or in conjunction with other drugs/procedures. In recent years, research using Provocholine has been effectively used to rule out asthma in patients, especially children, given that family history and other variables are taken into consideration.