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Completed

NCT Number: NCT00413205

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

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.

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Key information

Conditions

Emphysema Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

44 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Pleven, Bulgaria

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Placebo

Drug

po daily

RAR Gamma

Drug

5mg po daily

Primary outcomes

  1. Post-bronchodilator FEVI

    Time frame: At intervals throughout study, and 2 and 6 months after cessation of study drug

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study 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.

Important dates

Study start
2007
Primary completion
2010
Study completion
2010
First posted
Dec 19, 2006
Registry last updated
Nov 2, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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