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

November 1, 2016 updated by: Hoffmann-La Roche

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.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
491

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Bulgaria
      • Pleven, Bulgaria, 5800
      • Ruse, Bulgaria, 7002
      • Sofia, Bulgaria, 1431
      • Sofia, Bulgaria, 1606
  • Czech Republic
      • Brno, Czech Republic, 390 03
      • Karlovy Vary, Czech Republic, 360 09
      • Ostrava, Czech Republic, 708 52
      • Praha, Czech Republic, 150 06
      • Praha, Czech Republic, 180 01
      • Praha 5, Czech Republic, 150 30
  • Hungary
      • Balassagyarmat, Hungary, 2660
      • Budapest, Hungary, 1036
      • Nyiregyhaza, Hungary, 4400
      • Pecs, Hungary, 7635
      • Szombathely, Hungary, 9700
      • Torokbalint, Hungary, 2045
  • Iceland
      • Reykjavik, Iceland, 108
  • Israel
      • Ashkelon, Israel, 78306
      • Haifa, Israel, 31096
      • Petach Tikva, Israel, 49100
      • Ramat Gan, Israel, 52621
      • Rehovot, Israel, 76100
      • Tel Aviv, Israel, 6423906
  • Italy
    • Emilia-Romagna
      • Modena, Emilia-Romagna, Italy, 41100
    • Liguria
      • Genova, Liguria, Italy, 16132
    • Lombardia
      • Pavia, Lombardia, Italy, 27100
    • Toscana
      • Pisa, Toscana, Italy, 56124
  • Latvia
      • Daugavpils, Latvia, 5417
      • Riga, Latvia, LV-1002
      • Riga, Latvia, 1038
      • Riga, Latvia, 2118
  • Poland
      • Bialystok, Poland, 15-003
      • Katowice, Poland, 40-752
      • Lodz, Poland, 92-215
      • Poznan, Poland, 60-569
      • Poznan, Poland, 60-693
      • Warszawa, Poland, 01-138
      • Warszawa, Poland, 04-730
  • South Africa
      • Amanzimtoti, South Africa, 4126
      • Bellville, South Africa
      • Bloemfontein, South Africa, 9301
      • Cape Town, South Africa, 7925
      • Cape Town, South Africa, 8001
      • Centurion, South Africa, 0157
      • Durban, South Africa, 4001
      • Johannesburg, South Africa, 2006
      • Worcester, South Africa, 6850
  • Ukraine
      • Donetsk, Ukraine, 83099
      • Kiev, Ukraine, 03680
      • Kiev, Ukraine, 01133
  • United Kingdom
      • Coventry, United Kingdom, CV2 2DX
      • Liverpool, United Kingdom, L9 7AL
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35299
    • California
      • Los Angeles, California, United States, 90095-1690
      • San Diego, California, United States, 92103
      • Torrance, California, United States, 90502
    • Colorado
      • Denver, Colorado, United States, 80206
    • Illinois
      • Chicago, Illinois, United States, 60611
    • Michigan
      • Detroit, Michigan, United States, 48202-2689
    • Nebraska
      • Omaha, Nebraska, United States, 68198-2465
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73112
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19140
    • South Carolina
      • Spartanburg, South Carolina, United States, 29303
    • Texas
      • Houston, Texas, United States, 77030

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

44 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo
po daily
Drug: Placebo
po daily
Experimental: RAR Gamma
5mg po daily
Drug: RAR Gamma
5mg po daily

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Post-bronchodilator FEVI
Time Frame: At intervals throughout study, and 2 and 6 months after cessation of study drug
At intervals throughout study, and 2 and 6 months after cessation of study drug

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
DLCo, lung densitometry, SGRQ, lung volume, walk test, time to first COPD exacerbation.
Time Frame: At intervals throughout study
At intervals throughout study
AEs, SAEs, retinoid side effects, lab parameters.
Time Frame: Thoughout study
Thoughout study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hoffmann-La Roche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2007

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2010

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2010

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 18, 2006

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 18, 2006

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 19, 2006

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 2, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 1, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NB19751

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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