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

Status:	Completed
Conditions:	Chronic Obstructive Pulmonary Disease, Pulmonary
Therapuetic Areas:	Pulmonary / Respiratory Diseases
Healthy:	No
Age Range:	44 - Any
Updated:	8/3/2016
Start Date:	January 2007
End Date:	May 2010

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.

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.

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.

We found this trial at

sites

Clinical Trial Facility in Pleven

Pleven,

from

Pleven,