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and 80% of the predicted normal value or a
decline in FEV1 of 20% or more in the last 12
months for those >80% predicted
Study population Median age: 16 yrs, mean FEV1: 63% predicted
Trial Location Canada and Argentina
Commercial partners None
Primary end points:
Change in FEV1 8.6% increase (139 mls) on 400 mg Bronchitol.
-1.6% on 40 mg (p=0.0006). 4.6% on 240 mg,
3.7% on 120 mg
Change in FVC 7.9% increase in FVC on 400 mg vs -0.6% on 40 mg
(p=0.0004). 3.9% on 240 mg, 1.5% on 120 mg
Secondary end points:
Other lung function 11.9% increase in MMEF on 400 mg (vs -0.3% on 40
measures; mg, change did not reach significance)
CF Questionnaire Improved 6.3 points on 400 mg vs -0.2 on 40 mg
Safety/adverse events No serious adverse events on 400 mg Bronchitol
Forward-Looking Statements
The statements contained in this media release that are not purely
historical are forward-looking statements within the meaning of Section 21E
of the Securities Exchange Act of 1934, as amended. Forward-looking
statements in this media release include statements regarding our
expectations, beliefs, hopes, goals, intentions, initiatives or strategies,
including statements regarding the potential for Aridol and/or Bronchitol.
All forward-looking statements included in this media release are based
upon information available to us as of the date hereof, and we assume no
obligation to update any such forward-looking statement as a result of new
information, future events or otherwise. We cannot guarantee that any
product candidate will receive FDA or other regulatory approval or th
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