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

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

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

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), 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.

Resource links provided by NLM:

MedlinePlus related topics: Emphysema

U.S. FDA Resources

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:	January 2007
Estimated Study Completion Date:	November 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

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Locations

United States, Alabama

Birmingham, Alabama, United States, 35299
United States, California

Torrance, California, United States, 90502

San Diego, California, United States, 92103

Los Angeles, California, United States, 90095-1690
United States, Colorado

Denver, Colorado, United States, 80206
United States, Illinois

Chicago, Illinois, United States, 60611
United States, Michigan

Detroit, Michigan, United States, 48202-2689
United States, Nebraska

Omaha, Nebraska, United States, 68198-2465
United States, Oklahoma

Oklahoma City, Oklahoma, United States, 73112
United States, Pennsylvania

Philadelphia, Pennsylvania, United States, 19140
United States, South Carolina

Spartanburg, South Carolina, United States, 29303
United States, Texas

Houston, Texas, United States, 77030
Bulgaria

Sofia, Bulgaria, 1431

Sofia, Bulgaria, 1606

Ruse, Bulgaria, 7002

Sofia, Bulgaria, 1431

Pleven, Bulgaria, 5800
Czech Republic

Praha, Czech Republic, 150 06

Karlovy Vary, Czech Republic, 360 09

Praha, Czech Republic, 180 01

Tabor, Czech Republic, 390 03

Praha 5, Czech Republic, 150 30

Ostrava, Czech Republic, 708 52
Hungary

Nyiregyhaza, Hungary, 4400

Szombathely, Hungary, 9700

Torokbalint, Hungary, 2045

Pecs, Hungary, 7635

Budapest, Hungary, 1036

Balassagyarmat, Hungary, 2660
Iceland

Reykjavik, Iceland, 108
Israel

Petach Tikva, Israel, 49100

Rehovot, Israel, 76100

Ashkelon, Israel, 78306

Tel Aviv, Israel, 64239

Ramat Gan, Israel, 52621

Haifa, Israel, 31096
Italy

Modena, Italy, 41100

Pisa, Italy, 56124

Genova, Italy, 16132

Pavia, Italy, 27100
Latvia

Riga, Latvia, 1038

Riga, Latvia, 1002

Riga, Latvia, 2118

Daugavpils, Latvia, 5417
Poland

Warszawa, Poland, 04-730

Katowice, Poland, 40-752

Bialystok, Poland, 15-003

Poznan, Poland, 60-569

Warszawa, Poland, 01-138

Lodz, Poland, 92-215

Poznan, Poland, 60-569

Poznan, Poland, 60-693
South Africa

Durban, South Africa, 4001

Johannesburg, South Africa, 2006

Bellville, South Africa

Bloemfontein, South Africa, 9301

Cape Town, South Africa, 8001

Worcester, South Africa, 6850

Amanzimtoti, South Africa, 4126

Cape Town, South Africa, 7925

Centurion, South Africa, 0157
Ukraine

Kiev, Ukraine, 03680

Donetsk, Ukraine, 83099

Kiev, Ukraine, 01133
United Kingdom

Liverpool, United Kingdom, L9 7AL

Coventry, United Kingdom, CV2 2DX

Sponsors and Collaborators

Hoffmann-La Roche

Investigators

Study Director:

Clinical Trials

Hoffmann-La Roche

More Information

No publications provided

Responsible Party:	Hoffmann-La Roche ( Disclosures Group )
Study ID Numbers:	NB19751
Study First Received:	December 18, 2006
Last Updated:	November 17, 2009
ClinicalTrials.gov Identifier:	NCT00413205 History of Changes
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Pulmonary Emphysema
Emphysema
Lung Diseases, Obstructive
Pathologic Processes

Respiratory Tract Diseases
Lung Diseases
Pulmonary Disease, Chronic Obstructive

ClinicalTrials.gov processed this record on November 27, 2009