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

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

This study is ongoing, but not recruiting participants.

Study NCT00413205. Last updated on October 15, 2008. Information provided by Hoffmann-La Roche

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields

Brief Title ^†

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

Official Title ^†

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.

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.

Detailed Description

Study Phase

Phase II

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Primary Outcome Measure ^†

Post-bronchodilator FEVI [ Time Frame: At intervals throughout study, and 2 and 6 months after cessation of study drug ] [ Designated as safety issue: No ]

Secondary Outcome Measure ^†

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 ]

Condition ^†

Emphysema

Intervention ^†

Drug: RAR Gamma
Drug: Placebo

MEDLINE PMIDs

Links

Recruitment Information Fields

Recruitment Status ^†

Active, not recruiting

Enrollment ^†

480

Start Date ^†

February 2007

Completion Date

May 2010

Eligibility Criteria ^†

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.

Gender

Both

Ages

44 Years and older

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

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

Administrative Information Fields

NCT ID ^†

NCT00413205

Organization ID

NB19751

Secondary IDs ^††

Study Sponsor ^†

Hoffmann-La Roche

Collaborators ^††

Investigators ^†

Study Director:

Clinical Trials

Hoffmann-La Roche, +1 973 235 5000

Information Provided By

Hoffmann-La Roche

Verification Date

October 2008

First Received Date ^†

December 18, 2006

Last Updated Date

October 15, 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.