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: April 7, 2014
Last verified: April 2014
  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 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
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: April 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 April 22, 2014