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FDA Approves Pharmaxis' ARIDOL™ (Mannitol Inhalation Powder) Bronchial Challenge Test Kit for the Assessment of Bronchial Hyperresponsiveness
Date:10/6/2010

The ARIDOL test requires patients to inhale increasing doses of dry powder mannitol from a simple, hand-held device, which causes airways to narrow and contract when airway inflammation is present. The doses are contained in capsules that are administered at one-minute intervals until a positive response is achieved or until all the capsules have been inhaled, indicating a negative result.  A positive response is indicated when there is a 15% reduction in lung function from baseline compared to a 20% fall required by a methacholine challenge test.(2) The lower the dose required to cause bronchoconstriction, the more severe the bronchial hyperresponsiveness.    

"When testing patients for bronchial hyperresponsiveness with a methacholine test, there is the potential for a large reduction in lung function," added Dr. Storms. "In patients with mild symptoms and good lung function, ARIDOL can be useful to support a diagnosis of asthma.  ARIDOL is well tolerated by patients and has demonstrated fewer large drops in lung function than methacholine or exercise."

Other Bronchial Challenge Tests

Unlike other bronchial challenge tests, ARIDOL is a single-use test that requires less preparation time and eliminates reconstitution, use of a nebulizer to administer, clean-up and sterilization.  A positive ARIDOL test is complete in approximately 20 minutes, compared to an average of 44 minutes for a methacholine test.(1)  A methacholine test requires additional equipment to administer and a designated testing room with ventilation.(2)  Tests that use exercise to assess bronchial hyperresponsiveness require special equipment and conditions, and may not be appropriate for patients with physical limitations.

Safety/Efficacy Profile

The safety and efficacy of ARIDOL as a bronchial challenge test were verified in two global Phase III clinical trials, which assessed the effectiveness of the ARIDOL
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SOURCE Pharmaxis
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