Status:
COMPLETED
TESRA: (Treatment of Emphysema With a Gamma-Selective Retinoid Agonist)
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Emphysema
Eligibility:
All Genders
44+ years
Phase:
PHASE2
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 optimiz...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2010
Estimated Enrollment :
491 Patients enrolled
Trial Details
Trial ID
NCT00413205
Start Date
January 1 2007
End Date
May 1 2010
Last Update
November 2 2016
Active Locations (64)
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1
Birmingham, Alabama, United States, 35299
2
Los Angeles, California, United States, 90095-1690
3
San Diego, California, United States, 92103
4
Torrance, California, United States, 90502