Bronchial Challenge Test Kit Overview

ARIDOL is a bronchial challenge test kit containing the required capsules of dry powder mannitol for oral inhalation in graduated doses with the supplied single patient use inhaler necessary to perform one bronchial challenge test. Do not swallow ARIDOL capsules.

The airway response to bronchial challenge testing with ARIDOL is measured using forced expiratory volume in one second (FEV1).

Prior to bronchial challenge testing with ARIDOL, standard spirometry should be performed and the reproducibility of the resting FEV1 established.

2.2 Administration Instructions

An overview of the testing procedure can be found below. The ARIDOL bronchial challenge test should only be used with the provided inhaler. All remaining unused (opened and unopened) blister packs and the inhaler should be properly discarded at the completion of the test. See the ARIDOL Bronchial Challenge Test Kit instructions for complete instructions on the dosing and spirometry procedures.

a. A nose clip may be used if preferred. If so, apply nose clip to the patient and direct the patient to breathe through the mouth

b. Insert 0 mg capsule into inhalation device. Puncture capsule by depressing buttons on side of device slowly, and ONCE ONLY (a second puncture may fragment the capsules)

c. The patient should exhale completely, before inhaling from device in a controlled deep inspiration

d. At the end of deep inspiration, start 60 second timer, subject should hold breath for 5 seconds and exhale through mouth before removal of nose clip

e. At the end of 60 seconds, measure the FEV1 in duplicate (the measurement after inhaling the 0 mg capsule is the baseline FEV1)

f. Repeat steps a-e following the mannitol capsule dose steps from Table 1 below until the patient has a positive response or 635 mg of mannitol has been administered (negative test)

2.3 Bronchial Challenge Test Response and Patient Management

A positive response is achieved when the patient experiences a 15% reduction in FEV1 from (0 mg) baseline (or a 10% incremental reduction in FEV1 between consecutive doses). The test result is expressed as a PD15.

Patients with either a positive response to bronchial challenge testing with ARIDOL or significant respiratory symptoms should receive a standard dose of a short-acting inhaled beta-agonist and monitored until fully recovered to within baseline.