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
Overview
- Phase
- Phase 2
- Intervention
- TPI ASM8
- Conditions
- Asthma
- Sponsor
- Syntara
- Enrollment
- 16
- Locations
- 4
- Primary Endpoint
- Compare the AUC of the late asthmatic response (LAR) between treatments and placebo
- Status
- Completed
- Last Updated
- 12 years ago
Overview
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.
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 on target receptors, ECP , biomarkers of mast cells activation et PK profile will be studied.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Mild asthma, male and female aged 18-55 y.old
- •Steroid-naive, non-smoker
- •Dual responders
Exclusion Criteria
- •Any chronic disease(unstable)
- •Immunosuppressed, recent or ongoing steroid intake
- •Methacholine PC 20 \> 16 mg/mL
Arms & Interventions
TPI ASM8 low dose
Intervention: TPI ASM8
TPI ASM8 high dose
Intervention: TPI ASM8
Placebo
Intervention: TPI ASM8
Outcomes
Primary Outcomes
Compare the AUC of the late asthmatic response (LAR) between treatments and placebo
Time Frame: Day 14 (Between 3-7 hr post-AIC)
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
Secondary Outcomes
- 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)