NCT00413205

TESRA: (Treatment of Emphysema With a Gamma-Selective Retinoid Agonist)

A Double-blind, Placebo-controlled Efficacy (as Assessed by Post-bronchodilator FEV1) and Safety Study of RAR Gamma in Subjects With Smoking-related, Moderate to Severe COPD With Emphysema Receiving Concurrent Optimised COPD Drug Therapy.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 491 (actual)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 44 Years
• Healthy volunteers: Not accepted

Summary

This 2 arm study will investigate the efficacy, safety and tolerability of RAR Gamma versus placebo in ex-smokers with moderate or severe emphysema treated with optimal COPD therapy. Following optimization of COPD therapy (up to 6 weeks) patients will be randomized to receive either RAR Gamma (5mg) or placebo once daily using a 2:1 ratio (active:placebo), in addition to their standard therapy. Following the double-blind treatment period, patients will enter a 4-week follow-up period. The anticipated time on study period is 1-2 years, and the target sample size is 100-500 individuals.

Conditions

• Emphysema

Interventions

Type	Name	Description
DRUG	Placebo	po daily
DRUG	RAR Gamma	5mg po daily

Timeline

• Start date: 2007-01-01
• Primary completion: 2010-05-01
• Completion: 2010-05-01
• First posted: 2006-12-19
• Last updated: 2016-11-02

Locations

64 sites across 12 countries: United States, Bulgaria, Czechia, Hungary, Iceland, Israel, Italy, Latvia, Poland, South Africa, Ukraine, United Kingdom