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

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: Completed
• Conditions: Emphysema
• Intervention / Treatment: Drug: Placebo; Drug: RAR Gamma

• Study Type: Interventional
• Enrollment (Actual): 491
• Phase: Phase 2

Contacts and Locations

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

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Time Frame
Post-bronchodilator FEVI	At intervals throughout study, and 2 and 6 months after cessation of study drug

Secondary Outcome Measures

Outcome Measure	Time Frame
DLCo, lung densitometry, SGRQ, lung volume, walk test, time to first COPD exacerbation.	At intervals throughout study
AEs, SAEs, retinoid side effects, lab parameters.	Thoughout study

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche

Study record dates

Study Major Dates

• Study Start: January 1, 2007
• Primary Completion (Actual): May 1, 2010
• Study Completion (Actual): May 1, 2010

Study Registration Dates

• First Submitted: December 18, 2006
• First Submitted That Met QC Criteria: December 18, 2006
• First Posted (Estimate): December 19, 2006

Study Record Updates

• Last Update Posted (Estimate): November 2, 2016
• Last Update Submitted That Met QC Criteria: November 1, 2016
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Pulmonary Emphysema; Emphysema
• Other Study ID Numbers: NB19751