Trial Information

Summary: TESRA: (Treatment of Emphysema with a gamma-Selective Retinoid Agonist)

Status: No longer recruiting

Protocol Number: NB19751

Sponsor: Hoffmann-La Roche

Company Division: Pharmaceutical

Official Scientific Title: 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.

Brief 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. Target sample size is 480.

Study Phase: II

Study Design / Study Details:

• Purpose: Treatment
• Allocation: Randomized
• Masking: Double Blind
• Control: Placebo
• Assignment: Parallel
• Endpoints: Safety/Efficacy

Study Type:

Condition: Emphysema

Intervention Type: Drug

Intervention Name: RAR Gamma

Primary Outcome: 1. Post-bronchodilator FEVI Time frame: At intervals throughout study, and 2 and 6 months after cessation of study drug

Key Secondary Outcomes: 1. DLCo, lung densitometry, SGRQ, lung volume, walk test, time to first COPD exacerbation. Time frame: At intervals throughout study 2. AEs, SAEs, retinoid side effects, lab parameters. Time frame: Thoughout study

Inclusion Criteria:

Exclusion Criteria:

Gender: Males or Females

Age Limits: Min: 44 Years

Accepts Healthy Volunteers: No

Anticipated Start Date: February, 2007

Trial Registration Date: 12/18/2006

Date Last Updated: 10/16/2008

Link To Trial Results

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Trial listings updated: November 17, 2008 at 2:35:13 PM