Clinical Trials

 

Pharmaxis conducts its own clinical trials as part of the regulatory approvals process for Aridol™ and Bronchitol™.  We also support independent trials of our products to provide further evidence of the efficacy and safety of our products. Studies are being conducted by leading clinicians around the world, including Australia, New Zealand, UK, US, Canada and Switzerland.

If you would like to participate in a clinical trial being run by Pharmaxis, please contact us [link to Contact Us in the About Us section].

Aridol

Indication 

Phase 

Sponsor 

Description              

 Sites

 Patients

Status 

Related Media and Scientific Publications

Asthma 

III     A301

Pharmaxis

Registration trial

Australia

646 

Complete 

26Oct04  01Oct04  30Jul04 

Asthma

III

Investigator 

Aridol as a guide for asthma management in general practice

UK

300 

In progress 

12Aug04

Asthma

III     A305

Pharmaxis 

Pre-registration trial for US FDA

USA

501

Completed

16Nov06  28Aug06 14Dec05  23Dec04

COPD

II 

Investigator 

Australia

40 

In progress 

COPD 

II  COPD201

Pharmaxis 

Ability of Aridol to predict ICS* response

Australia

140 

Completed 

11apr06  15sep05  

COPD 

II 

Investigator 

Ability of Aridol to predict ICS* response

* ICS = Inhaled CorticoSteroids 

Switzerland

In progress 

11Apr06 21Apr04 

Pulm Pharmacol and Therapeutics 2005 

COPD II Investigator Response to ICS in patients with a positive Aridol test Switzerland In progress 15May07

Bronchitol

Indication 

Phase 

Sponsor 

Description

Sites 

Patients 

Status 

Related Media and Scientific Publications

Bronchiectasis 

II     B201

Pharmaxis 

Proof of concept

Australia NZ 

60 

Complete 

12May05   27Sep04   16Jul04   23Feb04 

Bronchiectasis

III    B301 

Pharmaxis 

Pre-registration trial

UK Australia New Zealand

360 

Complete

29Aug07 05Jul07  02Feb07   19apr06

Cystic Fibrosis 

II   CF201 

Pharmaxis 

Proof of concept — ability to improve FEV1 and quality of life

Australia NZ 

40 

Complete 

31Aug05  29Apr05  

Cystic Fibrosis 

II  CF202 

Pharmaxis 

Dosing study

Canada Argentina

42 

In progress 

28Nov05  21Jul05 

Cystic Fibrosis 

II  CF203 

Pharmaxis 

Comparison with Pulmozyme®/dornase alfa

UK

42 

In progress 

16Dec05  09Feb05   

Cystic Fibrosis

III CF301

Pharmaxis Long term administration of Bronchitol

UK, IRE, IT  Australia

250 In progress 11Apr07  06Oct06 
Cystic Fibrosis  III   CF302  Pharmaxis Long term administration of Bronchitol USA TBA In progress 08Nov07

Please contact Pharmaxis [link to Contact Us in About Us section] for further details about the progress of clinical trials.

Page last updated: 28 November 2007

 
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