Clinical Trials

Bronchitol®

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

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Cystic Fibrosis

Phase

Description	CF303: Treatment of adults with Cystic Fibrosis
Sites	126 Sites in Europe , Australia, Middle East, New Zealand, North America, Russia, South Africa, South America
Subjects	423
Status	Complete
More Information	NCT02134353*
Media Releases	Pharmaxis Announces Results of Pivotal Bronchitol Cystic Fibrosis Clinical Trial for US Market Pharmaxis Completes Treatment Phase in Pivotol Bronchitol Cystic Fibrosis Clinical Trial for US Market CF 303 Closes Recruitment Phase 3 clinical trial in Cystic Fibrosis begins

Phase

Description	CF302: Long Term Administration of Mannitol
Sites	EU, LA, USA Canada
Subjects	300
Status	Complete
More Information	NCT00630812*
Media Releases	Pharmaxis Presents New Analyses of Pooled Cystic Fibrosis Data at European Meeting Bronchitol reduces risk of exacerbations - additional data Extended benefit with Bronchitol in second Phase 3 CF Trial Pharmaxis announces positive combined Phase 3 CF trial results Pharmaxis announces results for second Phase 3 trial of Bronchitol in CF Pharmaxis announces milestone in Phase 3 trial for Cystic Fibrosis Second Cystic Fibrosis trial passes recruitment target Second pivotol phase 3 trial in cystic fibrosis begins Pharmaxis completes US FDA special protocol assessment US fast tracks Pharmaxis Cystic Fibrosis Drug Pharmaxis reports FDA and EMEA end of Phase 2 meetings

Phase

Description	CF301: Long term administration of Mannitol
Sites	Australia, IRE, IT, UK
Subjects	325
Status	Complete
More Information	NCT00446680*
Media Releases	Pharmaxis presents new analyses of Pooled Cystic Fibrosis Data at European Meeting Bronchitol reduces risk of exacerbations- additional data Pharmaxis announces sustained benefit with Bronchitol in Phase 3 Cystic Fibrosis trial Phase 3 cystic fibrosis trial results presented at European Conference Pharmaxis announces positive results of phase 3 Cystic Fibrosis Trial Pharmaxis announces milestone in Phase III Trial for Cystic Fibrosis Bronchitol phase 3 cystic fibrosis trial completes recruitment Phase 3 cystic fibrosis trial begins Pharmaxis receives UK approval for phase 3 Cystic Fibrosis Trial Pharmaixs reports FDA and EMEA end of Phase 2 meetings

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* 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