Research

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

BIOEQUIVALENCE

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

PHARMACODYNAMIC

FDA Draft Guidance on Albuterol Sulfate⁵
Pharmacodynamic Studies to Demonstrate Bioequivalence of Oral Inhalation Products⁶

BIOLOGICS

Effect of omalizumab on adenosine 5’-monophosphate responsiveness in subjects with allergic asthma⁷
Monoclonal antibodies and other biologic agents in the treatment of asthma⁸

To purchase Provocholine for your clinical studies, please contact Shannon Kapitor, Key Account
Manager, by phone (+1) 519.751.3602 ext. 7244 or by email skapitor@methapharm.com.

REFERENCES:

1. Guidance for Clinical Investigators, Sponsors, and IRBs. Investigational New Drug Applications (INDs) — Determining Whether Human Research
Studies Can Be Conducted Without an IND. FDA September 2013
2. Prabhakaran S, et al. Methacholine challenge as a clinical bioassay of pulmonary delivery of a long-acting β2-Adrenergic agonist. Pharmacotherapy
2011;31(5):449-457
3. Ahrens RC, et al. Therapeutic equivalence of Spiros dry powder inhaler and Ventolin metered dose inhaler: a bioassay using methacholine. AM J Respir
Crit Care Med 1999; 160:1238-1243
4. Nair P, et al. Clinical equivalence testing of inhaled bronchodilators. Pol Arch Med Wewn 2009;119(11):731-735
5. FDA Draft Guidance on Albuterol Sulfate Revised June 2013
6. Hendeles L, et al. Pharmacodynamic studies to demonstrate bioequivalence of oral inhalation products. AAPS J 2015 May;17(3):758-768
7. Prieto L, et al. Effect of Omalizumab on adenosine 5’-monophosphate responsiveness in subjects with allergic asthma. Int Arch Allergy Immunol.
2006;139(2):122-131
8. Long AA. Monoclonal antibodies and other biologic agents in the treatment of asthma. MAbs. 2009;May-Jun;1(3):237–246