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

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ClinicalTrials.gov Identifier: NCT00413205
Recruitment Status : Completed
First Posted : December 19, 2006
Last Update Posted : November 2, 2016
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Description
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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.

Condition or disease Intervention/treatment Phase
Emphysema Drug: Placebo Drug: RAR Gamma Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 491 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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.
Study Start Date : January 2007
Actual Primary Completion Date : May 2010
Actual Study Completion Date : May 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Emphysema
U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: Placebo
po daily
 Drug: Placebo
po daily
Experimental: RAR Gamma
5mg po daily
 Drug: RAR Gamma
5mg po daily


Outcome Measures
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Primary Outcome Measures :
  1. Post-bronchodilator FEVI [ Time Frame: At intervals throughout study, and 2 and 6 months after cessation of study drug ]

Secondary Outcome Measures :
  1. DLCo, lung densitometry, SGRQ, lung volume, walk test, time to first COPD exacerbation. [ Time Frame: At intervals throughout study ]
  2. AEs, SAEs, retinoid side effects, lab parameters. [ Time Frame: Thoughout study ]

Eligibility Criteria
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Ages Eligible for Study:   44 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00413205


  Show 64 Study Locations
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00413205     History of Changes
Other Study ID Numbers: NB19751
First Posted: December 19, 2006    Key Record Dates
Last Update Posted: November 2, 2016
Last Verified: November 2016

Additional relevant MeSH terms:
Emphysema
Pulmonary Emphysema
Pathologic Processes
Pulmonary Disease, Chronic Obstructive
 Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Diseases