Multiple Dose ASM8 in Mild Asthmatics
|ClinicalTrials.gov Identifier: NCT00264966|
Recruitment Status : Completed
First Posted : December 13, 2005
Last Update Posted : December 3, 2012
|Condition or disease||Intervention/treatment||Phase|
|Asthma||Drug: ASM8||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||15 participants|
|Intervention Model:||Crossover Assignment|
|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.|
|Study Start Date :||December 2005|
|Study Completion Date :||April 2006|
- 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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00264966
|Hamilton, Ontario, Canada, L8N 3Z5|
|Ste-Foy, Quebec, Canada, G1V 4G5|
|Saskatoon, Saskatchewan, Canada, S7N 0W8|
|Principal Investigator:||Paul O'Byrne, MD||McMaster University|