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
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Asthma | Drug: ASM8 | Phase 1 Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Enrollment : | 15 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | Double |
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. |
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

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Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Part 1: Men and women 18 to 65 years of age; generally good health; mild to moderate, stable, allergic asthma as defined by ATS criteria (1); history of episodic wheeze and shortness of breath; forced expiratory volume in 1 second (FEV1) at baseline ≥70% of the predicted value; able to comprehend and follow all required study procedures; willing and able to sign an informed consent form.
Part 2: Methacholine challenge at baseline (PC20 ≤16 mg/mL); positive skin-prick test to common aeroallergens (cat, dust mite, grass, pollen) and positive allergen-induced early and late airway bronchoconstriction.
Exclusion Criteria:
- Part 1 and Part 2: Significant acute or chronic medical or psychiatric illness; known coagulopathy, worsening of asthma or respiratory infection in the preceding 6 weeks; use of inhaled or oral corticosteroids within the last 28 days, antihistamines, immunosuppressives, nonsteroidal anti-inflammatory drugs, or anticoagulants (intermittent doses of short-acting β2-agonist are allowed); use of medications that may interact with ASM8; investigational drug use within 30 days; any clinically significant abnormality on screening laboratory determinations; current tobacco use in previous 3 months or 10 pack-years; pregnant or lactating women; women actively seeking pregnancy or who are not using adequate contraception; history of serious adverse effect (SAE) or hypersensitivity to any drug; 20% decrease in FEV1 or FVC with baseline saline in methacholine challenge during screening.

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
Canada, Ontario | |
McMaster University | |
Hamilton, Ontario, Canada, L8N 3Z5 | |
Canada, Quebec | |
Hopital Laval | |
Ste-Foy, Quebec, Canada, G1V 4G5 | |
Canada, Saskatchewan | |
Saskatoon Hospital | |
Saskatoon, Saskatchewan, Canada, S7N 0W8 |
Principal Investigator: | Paul O'Byrne, MD | McMaster University |
ClinicalTrials.gov Identifier: | NCT00264966 |
Other Study ID Numbers: |
ASM8-003 |
First Posted: | December 13, 2005 Key Record Dates |
Last Update Posted: | December 3, 2012 |
Last Verified: | November 2012 |
Mild asthma |
Asthma Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases |
Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases |