Overview

Efficacy of TPI ASM8 During a 14-Day Allergen Challenge

Status:
Completed
Trial end date:
2012-02-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Pharmaxis
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