Clinical Trials

Bronchitol®

Pharmaxis has conducted a number of clinical trials as part of the regulatory approvals process for Bronchitol.

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Bronchiectasis

No further clinical development is planned for bronchiectasis.

Phase III

Description	B305: Long term administration of Bronchitol
Sites	Australia, EU, LA, New Zealand, US
Subjects	485
Status	Complete
More Information	NCT00669331*
Media Releases	Phase 3 Clinical Trial in Bronchiectasis (B305) Fails Primary Endpoint; Meets Key Secondary Endpoints on Efficacy and Safety Milestone in Phase 3 Trial for Bronchiectasis Major Phase III trial of Bronchitol in Bronchiectasis reaches recruitment target Pharmaxis commences pivotal bronchiestasis study and aligns global Bronchitol registration strategy Pharmaxis concludes special protocol assessment with FDA for Bronchitol Phase 3 Trial Regulatory path for Bronchitol in bronchiectasis No further clinical development planned in Bronchiectasis

Phase III

Description	B301: Pre Registration trial
Sites	Australia, New Zealand, UK
Subjects	360
Status	Complete
More Information	NCT00277537*
Media Releases	12 month Phase 3 trial finds Bronchitol safe in bronchiectasis Long-term safety study of Bronchitol Completes Phase 3 trial finds Pharmaxis' Bronchitol effective Pharmaxis completes phase 3 bronchiectasis trial Phase 3 Bronchitol Clinical trial fully recruited Pharmaxis enrols first patient in phase 3 bronchietasis trial

Phase II

Description	B201 and B202: Proof of Concept
Sites	Australia, New Zealand
Subjects	60
Status	Complete
More Information	N/A
Media Releases	Pharmaxis announces positive results from phase 2 trial for Bronchitol Pharmaxis successfully completes enrolment for phase 2 trial of Bronchitol in Bronchiectasis Pharmaxis completes interim analysis on Bronchitol study

* ClinicalTrials.gov is a service provided by the U.S. National Institutes of Health, Department of Health and Human Services, through its National Library of Medicine. ClinicalTrials.gov provides patients, family members, and members of the public easy and free access to information on clinical studies for a wide range of diseases and conditions. Pharmaxis chooses to publish all Pivotal Trials on the ClinicalTrials.gov website.

** Pubmed is a service of the U.S. National Library of Medicine and the National Institutes of Health.

*** No further clinical development planned in Bronchiectasis