To determine the safety and efficacy of multiple doses of ASM8 antisense oligonucleotides in asthmatics.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
15
McMaster University
Hamilton, Ontario, Canada
Hopital Laval
Ste-Foy, Quebec, Canada
Saskatoon Hospital
Saskatoon, Saskatchewan, Canada
Comparison of the allergen-induced late asthmatic response (LAR) between ASM8 and placebo
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
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