Pharmaxis, Exton, Pa, has received approval from the US Food and Drug Administration (FDA) to market ARIDOL™ (mannitol inhalation powder) Bronchial Challenge Test Kit. ARIDOL is used for the assessment of bronchial hyperresponsiveness in patients 6 years of age and older who do not have clinically apparent asthma.
ARIDOL should not be used as a stand alone tool to assess asthma, but as a part of a physician’s overall assessment of asthma, advises the company. It is expected to be commercially available early next year.
The ARIDOL test requires patients to inhale increasing doses of dry powder mannitol from a 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 1-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. According to the company, a positive ARIDOL test is complete in approximately 20 minutes.