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Pharmaxis Previews New Bronchial Challenge Test at the Annual Meeting of the American College of Allergy, Asthma and Immunology
Date:11/10/2010

s complete in approximately 20 minutes, compared to an average of 44 minutes for a methacholine test.(1)  A methacholine test requires a nebulizer to administer, a 20% reduction in FEV1 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.

How ARIDOL Works

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 test result.   A positive response is indicated when there is a 15% reduction in (FEV1) from baseline or a 10% incremental reduction in (FEV1) between successive doses.  The lower the dose required to cause bronchoconstriction, the more severe the bronchial hyperresponsiveness.  

Safety/Efficacy Profile

The safety and efficacy of ARIDOL as a bronchial challenge test were demonstrated in two global Phase III clinical trials, which assessed the effectiveness of the ARIDOL bronchial challenge test in patients with symptoms suggestive of asthma and in clinically diagnosed asthmatic patients six years of age and older.  ARIDOL demonstrated consistent effectiveness across both study populations.  Approved for use in 19 countries, ARIDOL has been used by more than 44,000 patients, and is marketed in Australia, major European countries and Korea.  

ARIDOL is included in official international guidelines for the clinical assessment of asthma. Organizations and guidelines endorsing ARIDOL include: the International Olympic Committee Medical Commission's Independent Panel on Asthma, the U.S.
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Related medicine technology :

1. Pharmaxis Long-Term Safety Study of Bronchitol Completes
2. Pharmaxis Establishes Named Patient Program for Bronchitol
3. Pharmaxis Concludes Special Protocol Assessment with FDA for Bronchitol Phase 3 Trial
4. ASX/NASDAQ Media Release: Pharmaxis Files First Marketing Application for Bronchitol in Australia
5. Pharmaxis Announces New Drug Application Submission for Aridol(TM)
6. Pharmaxis Announces Milestone in Phase III Trial for Cystic Fibrosis
7. Pharmaxis Announces Positive Results of Phase 3 Cystic Fibrosis Trial
8. FDA Approves Pharmaxis ARIDOL™ (Mannitol Inhalation Powder) Bronchial Challenge Test Kit for the Assessment of Bronchial Hyperresponsiveness
9. Pharmaxis Announces Positive Combined Phase 3 Cystic Fibrosis Trial Results
10. Emphasys Medical Granted Expedited Review From FDA for Zephyr(R) Endobronchial Valve
11. Pivotal Data Show Bronchial Thermoplasty Can Improve Quality of Life and Reduce Asthma Attacks and Emergency Room Visits for Adults with Severe Asthma
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