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

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00413205

Enrollment

491

Registered

2006-12-19

Start date

2007-01-31

Completion date

2010-05-31

Last updated

2016-11-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Emphysema

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.

Interventions

DRUGPlacebo

po daily

DRUGRAR Gamma

5mg po daily

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

44 Years to No maximum

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.

Design outcomes

Primary

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

Secondary

Measure	Time frame
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

Countries

Bulgaria, Czechia, Hungary, Iceland, Israel, Italy, Latvia, Poland, South Africa, Ukraine, United Kingdom, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026