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 (cont’d)

Phase III

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

Phase II

Description	CF204: Paediatric Study
Sites	Belgium, France, Germany, Italy, Netherlands, Switzerland, United Kingdom, Canada
Subjects	92
Status	Complete
More Information	NCT01883531* Inhaled dry powder mannitol in children with cystic fibrosis: a randomised efficacy and safety trial
Media Releases	Bronchitol Paediatric Cystic Fibrosis Clinical Trial Reports Positive Results European CF Clinical Trial in Paediatric Patients begins

Phase II

Description	CF203: Comparison with Pulmozyme®/dornase alfa
Sites	UK
Subjects	20
Status	Complete
More Information	NCT00117208*
Media Releases	CF trial in children returns positive data Phase 2 cystic fibrosis study closes enrolment Bronchitol European cystic fibrosis study commences Pharmaxis to commence UK phase 2 trial for Bronchitol in Cystic Fibrosis

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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