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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00413205
First received: December 18, 2006
Last updated: July 7, 2014
Last verified: July 2014
  Purpose

This 2 arm study will investigate the efficacy, safety and tolerability of RAR G amma versus placebo in ex-smokers with moderate or severe emphysema treated with optimal COPD therapy. Following optimization of COPD therapy (up to 6 weeks) pa tients will be randomized to receive either RAR Gamma (5mg) or placebo once dail y using a 2:1 ratio (active:placebo), in addition to their standard therapy. Fol lowing 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 sampl e size is 100-500 individuals.


Condition Intervention Phase
Emphysema
Drug: RAR Gamma
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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:


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 ]

Enrollment: 491
Study Start Date: January 2007
Study Completion Date: May 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: RAR Gamma
5mg po daily
Placebo Comparator: 2 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

  Show 64 Study Locations
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00413205     History of Changes
Other Study ID Numbers: NB19751
Study First Received: December 18, 2006
Last Updated: July 7, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Emphysema
Pulmonary Emphysema
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on July 28, 2014