Multiple Dose ASM8 in Mild Asthmatics
To determine the safety and efficacy of multiple doses of ASM8 antisense oligonucleotides in asthmatics.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Primary Purpose: Treatment
|Official Title:||A Double-blind, Placebo-controled, Crossover Study To Evaluate the Efficacy, Safety and Tolerability of Inhaled ASM8-003 in Subjects With Mild Allergic Asthma.|
- 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
|Study Start Date:||December 2005|
|Study Completion Date:||April 2006|
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.
|Hamilton, Ontario, Canada, L8N 3Z5|
|Ste-Foy, Quebec, Canada, G1V 4G5|
|Saskatoon, Saskatchewan, Canada, S7N 0W8|
|Principal Investigator:||Paul O'Byrne, MD||McMaster University|