Pharmaxis Completes Phase II Clinical Study with ASM8 in Asthma Patients
Release Date: 17/04/2012 12:00am
Pharmaxis Ltd today announced the completion of an exploratory Phase IIa trial with ASM8 in patients with allergic asthma.
The trial was a double-blind, randomized, controlled, 3-way crossover study to evaluate the efficacy and safety of 14-day inhaled ASM8 in subjects with asthma. The primary outcome measure was the effect of ASM8 on allergen induced Late Allergic Response 3-7 hours post-allergen challenge. 16 subjects participated in the trial and each received two doses of ASM8 (3mg or 7.8mg) or control at different times, once per day in a randomized, cross over fashion.
Bronchoconstriction (as measured by change in FEV1) during the late phase of the allergen challenge response was reduced by 44% (p<0.05) when dosed with3mg and by 41% (p<0.01) when dosed with 7.8mg ASM8, as assessed by the change in area under the curve, 3-7 hours post challenge compared to screening. This is consistent with a previously reported trial that reduced the Late Allergen Response by 59% (p<0.005) following 4 day dosing with 8mg ASM8. However, in the current trial, the control also reduced the Late Allergen Response by 44% (p<0.005), 3-7 hours post dose, meaning there was no difference between doses.
The statistically significant effect of the response when subjects were treated with vehicle is indicative of a drug carryover effect that can result in studies of a cross over design.
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