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

Purpose

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.

Condition	Intervention	Phase
Emphysema	Drug: RAR Gamma Drug: Placebo	Phase II

MedlinePlus related topics:

Emphysema

U.S. FDA Resources

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

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.

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:

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 Measures:

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 ]

Estimated Enrollment:	480
Study Start Date:	February 2007
Estimated Study Completion Date:	June 2010

Arms	Assigned Interventions
1: Experimental	Drug: RAR Gamma 5mg po daily
2: Placebo Comparator	Drug: Placebo po daily

Eligibility

Ages Eligible for Study:	44 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00413205

Show 66 Study Locations

Sponsors and Collaborators

Hoffmann-La Roche

Investigators


Study Director:	Clinical Trials	Hoffmann-La Roche, +1 973 235 5000

More Information

Responsible Party:	Hoffmann-La Roche ( Clinical Trials, Study Director )
Study ID Numbers:	NB19751
First Received:	December 18, 2006
Last Updated:	August 18, 2008
ClinicalTrials.gov Identifier:	NCT00413205
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Pulmonary Emphysema

Smoking

Emphysema

Lung Diseases, Obstructive

Respiratory Tract Diseases

Lung Diseases

Pulmonary Disease, Chronic Obstructive

Additional relevant MeSH terms:

Pathologic Processes

ClinicalTrials.gov processed this record on September 05, 2008

Sponsored by:	Hoffmann-La Roche
Information provided by:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00413205