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

Phase 2

Completed

• Conditions: Emphysema
• Interventions: Drug: RAR Gamma; Drug: Placebo

• Registration Number: NCT00413205
• Lead Sponsor: Hoffmann-La Roche

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2006-12-18
• Study First Submitted QC: 2006-12-18
• Study First Posted: 2006-12-19
• Study Start: 2007-01
• Primary Completion: 2010-05
• Study Completion: 2010-05
• Disposition First Submitted: 2016-07-06
• Disposition First Submitted QC: 2016-07-06
• Disposition First Posted: 2016-07-11
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-01
• Last Update Posted: 2016-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 491

Inclusion Criteria

• patients of >44 years of age, with >10 pack-year smoking history;
• women not of child-bearing potential;
• ex-smokers (must have stopped smoking for >=12 months) with clinical diagnosis of emphysema;
• willing to be switched to optimal COPD therapy.

Exclusion Criteria

• off oral steroids >28 days prior to enrollment;
• >2 exacerbations of pulmonary symptoms requiring outpatient treatment, or >1 exacerbation requiring hospitalization, within 12 months prior to screening;
• exposure to synthetic oral retinoids in past 12 months;
• history of allergy or sensitivity to retinoids.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
RAR Gamma	RAR Gamma	5mg po daily
Placebo	Placebo	po daily

Primary Outcome Measures

Name	Time	Method
Post-bronchodilator FEVI	At intervals throughout study, and 2 and 6 months after cessation of study drug

Secondary Outcome Measures

Name	Time	Method
DLCo, lung densitometry, SGRQ, lung volume, walk test, time to first COPD exacerbation.	At intervals throughout study
AEs, SAEs, retinoid side effects, lab parameters.	Thoughout study