Efficacy of TPI ASM8 During a 14-Day Allergen Challenge

A Double-Blind,Randomized, Placebo-controlled, 3-Way Cross Over Study to Evaluate the Efficacy and Safety of 14 Days TPI ASM8 in Subjects With Asthma

This is a randomized, double-blind, placebo-controlled, 3-way crossover trial to evaluate the efficacy and safety of two different doses of inhaled TPI ASM8 administered daily for 14 days for the treatment of allergic asthma and allergen-induced asthma.

Two doses of TPI ASM8 will be compared to placebo and look at the effect on asthmatic responses after an allergen challenge during a 3-way cross over design. Sputum inflammation , mRNA gene expression on target receptors, ECP , biomarkers of mast cells activation et PK profile will be studied.

Inclusion Criteria:

• Mild asthma, male and female aged 18-55 y.old
• Steroid-naive, non-smoker
• Dual responders

Exclusion Criteria:

• Any chronic disease(unstable)
• Immunosuppressed, recent or ongoing steroid intake
• Methacholine PC 20 > 16 mg/mL