Efficacy of TPI ASM8 During a 14-Day Allergen Challenge
A Double-Blind,Randomized, Placebo-controlled, 3-Way Cross Over Study to Evaluate the Efficacy and Safety of 14 Days TPI ASM8 in Subjects With Asthma
1 other identifier
interventional
16
1 country
4
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 treatment of allergic asthma and allergen-induced asthma.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2 asthma
Started Nov 2010
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 17, 2010
CompletedFirst Posted
Study publicly available on registry
July 8, 2010
CompletedStudy Start
First participant enrolled
November 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2012
CompletedNovember 15, 2013
November 1, 2013
1.1 years
June 17, 2010
November 14, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Compare the AUC of the late asthmatic response (LAR) between treatments and placebo
The area under the curve fo the late asthmatic response(% fall in FEV1)(between 3-7 hrs post allergen challenge) will be compared between the 2 doses of TPI ASM8 and the placebo
Day 14 (Between 3-7 hr post-AIC)
Secondary Outcomes (4)
Compare the early and late asthmatic responses between active treatments and placebo after 14 days treatment
Day 14
Compare the Methacholine Hyperresponsiveness (PC20) between treatment pre and post allergen challenge
Day 13 and Day 15 (Pre & post AIC)
Effect of ASM8 on mast cells (as measured by specific biomarkers)
Day 14 (pre, post and and peri-AIC)
Sputum inflammation indicators (Eos, neutrophils, etc.)
Day 14 and Day 15
Study Arms (3)
TPI ASM8 low dose
ACTIVE COMPARATORTPI ASM8 high dose
ACTIVE COMPARATORPlacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Mild asthma, male and female aged 18-55 y.old
- Steroid-naive, non-smoker
- Dual responders
You may not qualify if:
- Any chronic disease(unstable)
- Immunosuppressed, recent or ongoing steroid intake
- Methacholine PC 20 \> 16 mg/mL
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Syntaralead
Study Sites (4)
Health Research Innovation Centre
Calgary, Alberta, T2N 4N1, Canada
Vancouver Coastal Health Research Institute
Vancouver, British Columbia, V5Z 1M9, Canada
McMaster University
Hamilton, Ontario, L8N 3Z5, Canada
Laval Centre de Pneumologie Chest Division
Québec, Quebec, G1V4G5, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Paul O'Byrne, MD
McMaster University
- STUDY DIRECTOR
Rene Pageau, M.Sc Pharm
Pharmaxis Ltd
- PRINCIPAL INVESTIGATOR
Louis-Philippe Boulet, MD
Hopital Laval, Quebec
- PRINCIPAL INVESTIGATOR
Richard Leigh, MD
University of Calgary
- PRINCIPAL INVESTIGATOR
Gail M Gauveau, PhD
McMaster University
- PRINCIPAL INVESTIGATOR
Mark Fitzgerald, MD
Vancouver Coastal Health Research Institute
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 17, 2010
First Posted
July 8, 2010
Study Start
November 1, 2010
Primary Completion
December 1, 2011
Study Completion
February 1, 2012
Last Updated
November 15, 2013
Record last verified: 2013-11