Primary Outcome Measures:
- Comparison of the allergen-induced late asthmatic resposne (LAR) between ASM8 and placebo
Secondary Outcome Measures:
- Evaluation of the safety and tolerability of ASM8.
- Comparison of the allergen-induced early asthmatic response (EAR) between ASM8 and placebo.
- Comparison of the allergen-induced airway hyperresponsiveness between ASM8 and placebo.
- Comparison of the allergen-induced changes in sputum eosinophils at 7 and 24 hours post allergen, between the ASM8 and placebo.
- Determination of the plasma and sputum pharmacokinetic profile of single- and repeated-doses of ASM8 in patients with mild asthma.
- Determination of the pharmacodynamic activity of ASM8 on specific gene expression, protein levels, differential cell counts, and eosinophilic cationic protein (ECP), as measured in sputum samples.
- Relief medication use in the ASM8 versus placebo
This is a double-blind, placebo-controlled, crossover trial to evaluate the safety, tolerability and efficacy of inhaled ASM8 for the treatment of allergen-induced asthma. Individuals with stable, mild to moderate allergic asthma by American Thoracic Society (ATS) criteria (1), with a history of episodic wheeze and shortness of breath, will be eligible for enrolment. The study is divided into 2 parts.