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Enrolment Commenced in Aridoltm Copd Study
15 / 09 / 2005
Pharmaxis (ASX:PXS; NASDAQ: PXSL) is pleased to announce that its AridolTM Phase II clinical trial in 140 patients with chronic obstructive pulmonary disease (COPD) has enrolled its first patient. The study is designed to assess the ability of Aridol to predict the usefulness of inhaled corticosteroids as a treatment for COPD. It is being conducted in 12 sites throughout Australia.
All patients in the study will receive an Aridol test at the beginning of the trial, and then begin a 12 week course of inhaled corticosteroids. The trial will record differences in lung function, quality of life and general health of the patient. Full patient recruitment is expected to take about six months and, with a treatment period of three months, results are not expected before the quarter ending September 30, 2006.
Alan Robertson, Pharmaxis chief executive officer said: rThis latest trial will assess the potential second use for Aridol. According to our preliminary data, only one in five COPD patients respond to inhaled steroids. Our expectation is that Aridol will be able to identify the responders. If successful, Aridol has the potential to cut the consumption of inhaled steroids and reduce expense and unnecessary side effects for a large number of patients._
COPD is the world_s fourth largest cause of death, and is estimated to affect about 30 million people in the western world.
To find out more about Pharmaxis, go to http://www.pharmaxis.com.au.
About the trial
The following information is provided in accord with the ASX and AusBiotech draft Code of Best Practice for Reporting by Biotechnology, Medical Device and other Life Sciences Companies.
Name of Trial
DPM-COPD-201 (a Phase II study with Aridol)
Blinding Status
Open
Placebo Controlled
No
Treatment Method Route
Inhalation
Frequency
Once only, before treatment with inhaled corticosteroids
Dose level
0 "C 635mg inhaled mannitol
No of subjects
140
Subject Selection Criteria
Aged 45 - 80 years, male and female, Y 10 pack years smoking history, spirometry consistent with COPD (pre-bronchodilator FEV1 Y60% (and >1.4L) and FEV1/FVC <70%), symptoms of dyspnoea and/or chronic cough and/or excess sputum production,
untreated with ICS or oral steroids for a period of 6 weeks, clinically stable for 14 days prior to study entry.
Trial Location
Australia
Commercial partners involved
None
Expected duration 12 months
Primary end point
FEV1 for Aridol positive vs Aridol negative patients
Secondary end points
Aridol dose provoking a fall in FEV1 of 10% and 15%
Response dose ratio
Lung function parameters
Quality of life
Exacerbations
All patients in the study will receive an Aridol test at the beginning of the trial, and then begin a 12 week course of inhaled corticosteroids. The trial will record differences in lung function, quality of life and general health of the patient. Full patient recruitment is expected to take about six months and, with a treatment period of three months, results are not expected before the quarter ending September 30, 2006.
Alan Robertson, Pharmaxis chief executive officer said: rThis latest trial will assess the potential second use for Aridol. According to our preliminary data, only one in five COPD patients respond to inhaled steroids. Our expectation is that Aridol will be able to identify the responders. If successful, Aridol has the potential to cut the consumption of inhaled steroids and reduce expense and unnecessary side effects for a large number of patients._
COPD is the world_s fourth largest cause of death, and is estimated to affect about 30 million people in the western world.
To find out more about Pharmaxis, go to http://www.pharmaxis.com.au.
About the trial
The following information is provided in accord with the ASX and AusBiotech draft Code of Best Practice for Reporting by Biotechnology, Medical Device and other Life Sciences Companies.
Name of Trial
DPM-COPD-201 (a Phase II study with Aridol)
Blinding Status
Open
Placebo Controlled
No
Treatment Method Route
Inhalation
Frequency
Once only, before treatment with inhaled corticosteroids
Dose level
0 "C 635mg inhaled mannitol
No of subjects
140
Subject Selection Criteria
Aged 45 - 80 years, male and female, Y 10 pack years smoking history, spirometry consistent with COPD (pre-bronchodilator FEV1 Y60% (and >1.4L) and FEV1/FVC <70%), symptoms of dyspnoea and/or chronic cough and/or excess sputum production,
untreated with ICS or oral steroids for a period of 6 weeks, clinically stable for 14 days prior to study entry.
Trial Location
Australia
Commercial partners involved
None
Expected duration 12 months
Primary end point
FEV1 for Aridol positive vs Aridol negative patients
Secondary end points
Aridol dose provoking a fall in FEV1 of 10% and 15%
Response dose ratio
Lung function parameters
Quality of life
Exacerbations