NCT01158898

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Syntara · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Asthma

Interventions

Type	Name	Description
DRUG	TPI ASM8	ASM8 4mg/mL (low dose) daily for 14 days by inhalation
DRUG	TPI ASM8	ASM8 4mg/mL (high dose) daily for 14 days by inhalation
DRUG	TPI ASM8	Placebo PBS solution daily for 14 days by inhalation

Timeline

• Start date: 2010-11-01
• Primary completion: 2011-12-01
• Completion: 2012-02-01
• First posted: 2010-07-08
• Last updated: 2013-11-15

Locations

4 sites across 1 country: Canada