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

Completed · Phase 2 · Has a placebo group

Conditions studied: Emphysema

In brief

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.

Key facts

Study ID

NCT00413205

Run by

Hoffmann-La Roche

People needed

491

Starts

2007-01-01

Expected to finish

2010-05-01

Last updated by the study team

2016-11-02

Who can join

Age: 44 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Study site — Los Angeles, California, United States
• Study site — San Diego, California, United States
• Study site — Torrance, California, United States
• Study site — Denver, Colorado, United States
• Study site — Chicago, Illinois, United States
• Study site — Detroit, Michigan, United States
• Study site — Omaha, Nebraska, United States
• Study site — Oklahoma City, Oklahoma, United States
• Study site — Philadelphia, Pennsylvania, United States
• Study site — Spartanburg, South Carolina, United States
• Study site — Houston, Texas, United States
• Study site — Pleven, Bulgaria
• Study site — Rousse, Bulgaria
• Study site — Sofia, Bulgaria
• Study site — Sofia, Bulgaria
• Study site — Brno, Czechia
• Study site — Karlovy Vary, Czechia
• Study site — Ostrava, Czechia
• Study site — Prague, Czechia
• Study site — Prague, Czechia
• Study site — Prague, Czechia
• Study site — Balassagyarmat, Hungary
• Study site — Budapest, Hungary
• Study site — Nyíregyháza, Hungary
• Study site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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