Multiple Dose ASM8 in Mild Asthmatics
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|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)|
|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|
|Actual 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|