NCT00483743

Safety, Tolerability and PD Activity of Inhaled TPI 1020 Versus Inhaled Budesonide in COPD Patients

Multi-Center, Randomized, Double-Blind, Placebo and Active-Controlled, 6-week Study to Evaluate the Safety, Tolerability and Pharmacodynamic Activity of Inhaled TPI 1020 in COPD Patients.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 62 (actual)
• Sponsor: Syntara · Industry
• Sex: All
• Age: 40 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This study will assess and compare the safety and tolerability of inhaled TPI 1020 (repeated nominal doses; 500 μg BID x 6 weeks) versus inhaled budesonide (repeated doses; 800 μg BID x 6 weeks) and a matching placebo. Pharmacodynamic (PD) activity on FEV1, sputum and blood cells and cytokines will also be studied.

Detailed description

A multi-centre, randomized, placebo and active-controlled, 6-week study of inhaled TPI 1020, inhaled budesonide or matching placebo (random allocation of eligible patients to the three treatments at a ratio of 3:3:1), to evaluate the safety, tolerability and pharmacodynamic activity of TPI 1020 in 42 evaluable COPD subjects.

Conditions

• Copd Bronchitis

Interventions

Type	Name	Description
DRUG	TPI 1020	250 mcg/caps 2 caps BID x 42 days
DRUG	Budesonide	400mcg mcg capsules- 2 capsules BID
DRUG	Placebo	2 caps BID x42 days

Timeline

• Start date: 2007-11-01
• Primary completion: 2008-12-01
• Completion: 2008-12-01
• First posted: 2007-06-07
• Last updated: 2012-12-03

Locations

13 sites across 1 country: Canada