Status:
COMPLETED
Efficacy of TPI ASM8 During a 14-Day Allergen Challenge
Lead Sponsor:
Syntara
Conditions:
Asthma
Eligibility:
All Genders
18-55 years
Phase:
PHASE2
Brief Summary
This is a randomized, double-blind, placebo-controlled, 3-way crossover trial to evaluate the efficacy and safety of two different doses of inhaled TPI ASM8 administered daily for 14 days for the trea...
Detailed Description
Two doses of TPI ASM8 will be compared to placebo and look at the effect on asthmatic responses after an allergen challenge during a 3-way cross over design. Sputum inflammation , mRNA gene expression...
Eligibility Criteria
Inclusion
- Mild asthma, male and female aged 18-55 y.old
- Steroid-naive, non-smoker
- Dual responders
Exclusion
- Any chronic disease(unstable)
- Immunosuppressed, recent or ongoing steroid intake
- Methacholine PC 20 \> 16 mg/mL
Key Trial Info
Start Date :
November 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2012
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT01158898
Start Date
November 1 2010
End Date
February 1 2012
Last Update
November 15 2013
Active Locations (4)
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1
Health Research Innovation Centre
Calgary, Alberta, Canada, T2N 4N1
2
Vancouver Coastal Health Research Institute
Vancouver, British Columbia, Canada, V5Z 1M9
3
McMaster University
Hamilton, Ontario, Canada, L8N 3Z5
4
Laval Centre de Pneumologie Chest Division
Québec, Quebec, Canada, G1V4G5