NCT00402948

Safety and Efficacy of Two Dosages of Inhaled TPI ASM8 Compared to Placebo in Mild to Moderate Asthmatic Patients

Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel-Groups, To Evaluate And Compare The Safety, Tolerability And Efficacy Of Two Dosages Of Inhaled TPI ASM8 Administered For 14 Days In Patients With Mild to Moderate Asthma.

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Syntara · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This study will evaluate the efficacy, safety and tolerability of two dosages of a new drug TPI ASM8 administered by inhalation for 14 days to mild to moderate asthmatic patients, aged between 18-65, non-smokers . The study will also look at the nature and quantity of inflammatory white cells in the lung secretions and in the blood, and some additional inflammation markers.

Detailed description

See above

Conditions

• Asthma

Interventions

Type	Name	Description
DRUG	TPI ASM8	0.25mg, 0.5mg for 14 days, daily dosage
DRUG	ASM8	inhalation 0.25mg daily for 14 days

Timeline

• Start date: 2007-02-01
• Primary completion: 2007-11-01
• Completion: 2007-12-01
• First posted: 2006-11-23
• Last updated: 2012-12-03

Locations

10 sites across 1 country: Canada