NCT00550797

Study to Evaluate the Safety and Efficacy TPI ASM8 in Subjects With Asthma

A Multi-center, Double-blind, Randomized, Placebo-controlled, Crossover Study to Evaluate the Safety and Efficacy of 14-day Inhaled TPI ASM8 in Subjects With Asthma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Syntara · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The researchers propose to study the airways of asthmatics given TPI ASM8 for 14 days, and examine the protective effects on allergen-induced bronchoconstriction, hyperresponsiveness and airway inflammation.

Detailed description

Early and late asthmatic responses were attenuated by ASM8 and by placebo solution.Methacholine challenge was not affected by study medication. Other parameters were unchanged.

Conditions

• Allergic Asthma

Interventions

Type	Name	Description
BIOLOGICAL	TPI ASM8	Administered with the I-Neb device from Respironics once daily by inhalation over 2 treatment periods of 14 days each
BIOLOGICAL	placebo	Administered with the I-Neb device from Respironics once daily by inhalation over 2 treatment periods of 14 days each

Timeline

• Start date: 2008-01-01
• Primary completion: 2008-07-01
• Completion: 2008-10-01
• First posted: 2007-10-30
• Last updated: 2013-11-20

Locations

1 site across 1 country: United Kingdom