THE USE OF METHACHOLINE CHALLENGE TESTING IN CLINICAL TRIALS
Methacholine Challenge Testing is often used as part of the inclusion/exclusion criteria, or in determining a subject’s response to an investigational drug, as well as for epidemiological studies where bronchoprovocation testing is indicated. Provocholine is FDA approved and does not require an Investigational New Drug (IND) application for clinical use.
Studies that use a drug product that is prepared from raw materials in place of the approved, finished product marketed by the manufacturer must be conducted under an IND (21 CFR part 312).
These studies cannot meet the criteria for an exemption from the IND requirements for marketed drugs (§ 312.2(b)) because the drug product manufactured by the investigator or research pharmacy is not considered to be the lawfully marketed drug.1
Methacholine Challenge as a Clinical Bioassay of Pulmonary Delivery of a Long-Acting β2-Adrenergic Agonist2
Therapeutic Equivalence of Spiros Dry Powder Inhaler and Ventolin Metered Dose Inhaler: a Bioassay using Methacholine.3
Review Article: Clinical Equivalence Testing of Inhaled Bronchodilators4
FDA Draft Guidance on Albuterol Sulfate5
Pharmacodynamic Studies to Demonstrate Bioequivalence of Oral Inhalation Products6
Effect of omalizumab on adenosine 5’-monophosphate responsiveness in subjects with allergic asthma7
Monoclonal antibodies and other biologic agents in the treatment of asthma8