Status:
COMPLETED
Efficacy and Safety of Four Escalating Dose Regimens of TPI ASM8 in Patients With Allergic Asthma
Lead Sponsor:
Syntara
Conditions:
Asthma
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
During this proposed clinical trial, the investigators intend to evaluate the pharmacodynamic anti-inflammatory properties and safety of TPI ASM8, by investigating the effect on sputum eosinophils and...
Detailed Description
The early and late asthmatic response were both significantly attenuated by the highest dose of ASM8. The methacholine challenge and other parameters (ECP, mRNA knockdown on CCR3 and B-Chain of IL-3-I...
Eligibility Criteria
Inclusion
- Men and women 18 to 65 years of age
- Generally good health; steroid naïve (or who have not taken inhaled/oral corticosteroid within last month) mild to moderate, stable, allergic asthma as defined by ATS criteria
- History of episodic wheeze and shortness of breath
- Forced expiratory volume in one 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.
Exclusion
- 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 30 days, or need for antihistamines within 72 hours of each allergen or methacholine challenge, immunosuppressives, nonsteroidal anti-inflammatory drugs, or anticoagulants (intermittent doses of short-acting β2-agonist are allowed).
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2010
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT00822861
Start Date
April 1 2009
End Date
February 1 2010
Last Update
November 15 2013
Active Locations (1)
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1
McMaster University
Hamilton, Ontario, Canada, L8N 3Z5