Package Insert Indication
Provocholine is indicated for the diagnosis of bronchial airway hyperreactivity in subjects who do not have clinically apparent asthma.
The Provocholine (methacholine chloride) challenge test is highly sensitive, and the results are very accurate. The low incidence of false-negative or false-positive results with Provocholine is due to the specificity of cholinergic stimulation. A negative methacholine challenge test in a patient, rules out asthma with reasonable certainly.
Provocholine is precision weighed to ensure the accuracy of the 100mg of product in each vial. With the methacholine challenge test being a dose response test, this measurement is essential.
Provocholine is the only FDA-approved methacholine chloride for human use and, as such, is the subject to the FDA’s stringent regulations on drug purity. Each vial is labeled with the product NDC and is packaged in airtight vials to ensure that the quality and potency of the drug is not compromised.
Starting with a premeasured vial of powder, serial dilutions can be prepared quickly. The spirometry measurements taken during the challenge testare collected within five minutes of each concentration beingdelivered, providing immediate results.
Always consider objective measurements when contemplating an asthma diagnosis. There are several consequences associated with improper treatment such as: lost opportunity to diagnose the cause of symptoms, potential exposure to inappropriate medications, lost employment opportunities (i.e., military, public services), social consequences and economic factors.
Several studies have shown that patients with physician diagnosed asthma may have been misdiagnosed in approximately 1/3 of cases. To confirm a diagnosis of asthma, objective testing should be performed.The pathway for diagnosing asthma is outlined in the visual below the listed indications.
Methacholine challenge testing is most often considered when asthma is a serious possibility and traditional methods, most notably spirometry performed before and after administration of a bronchodilator, have not established or eliminated the diagnosis.
Apart from epidemiological or clinical research, these tests are most often done to exclude or confirm a suspected diagnosis of asthma. Demonstration by spirometry of reversible airflow obstruction is considered confirmatory; however, spirometry is often not available at the time of symptoms and may be inconclusive when it is done, especially in those with normal or near-normal lung function values. If symptoms, spirometry or response to therapy are atypical, a BCT is appropriate and can increase or decrease the probability of asthma. In the setting of ongoing clinical symptoms, a negative result to a test with relatively high sensitivity, such as a MCT, may be most helpful in making current asthma unlikely. In Contrast, a positive MCT, unless at a very low dose, cannot confirm asthma. BCTs are also used in screening applicants for situations where AHR would present a high safety risk, such as commercial diving, submarine service and some occupational exposures