| December 18, 2006 |
| November 17, 2009 |
| January 2007 |
| |
| Post-bronchodilator FEVI [ Time Frame: At intervals throughout study, and 2 and 6 months after cessation of study drug ] [ Designated as safety issue: No ] |
| Post-bronchodilator clinic FEV1 at baseline, 3, 6, 9, 12, 15, 18, 21 and 24 months, and 2 and 6 months after cessation of study drug. |
| Complete list of historical versions of study NCT00413205 on ClinicalTrials.gov Archive Site |
- DLCo, lung densitometry, SGRQ, lung volume, walk test, time to first COPD exacerbation. [ Time Frame: At intervals throughout study ] [ Designated as safety issue: No ]
- AEs, SAEs, retinoid side effects, lab parameters. [ Time Frame: Thoughout study ] [ Designated as safety issue: No ]
|
| Efficacy: DLCo (TLco), lung densitometry, SGRQ, lung volume, 6 min walk test, time to first COPD exacerbation. Safety: AEs, SAEs, retinoid side effects, laboratory parameters. |
| |
| 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. |
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. |
| |
| Phase II |
| Interventional |
| Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study |
| Emphysema |
- Drug: RAR Gamma
- Drug: Placebo
|
| |
| |
| |
| Active, not recruiting |
| 480 |
| November 2010 |
|
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.
|
| Both |
| 44 Years and older |
| No |
| Contact information is only displayed when the study is recruiting subjects |
| United States, Bulgaria, Czech Republic, Hungary, Iceland, Israel, Italy, Latvia, Poland, South Africa, Ukraine, United Kingdom |
| |
| NCT00413205 |
| Disclosures Group, Hoffmann-La Roche |
| NB19751 |
| Hoffmann-La Roche |
|
| Study Director: |
Clinical Trials |
Hoffmann-La Roche |
|
|
| Hoffmann-La Roche |
| November 2009 |
