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

Roche

Status and phase

Completed

Phase 2

Conditions

Emphysema

Treatments

Drug: RAR Gamma

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT00413205

NB19751

Details and patient eligibility

About

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.

Enrollment

491 patients

Sex

All

Ages

44+ years old

Volunteers

No Healthy Volunteers

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.