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

NCT00413205 | Completed Phase 2

• 1 other identifier: NB19751
• Study Type: interventional
• Target: 491
• Locations: 12 countries
• Sites: 64

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.

Conditions

Emphysema

Outcome Measures

Primary Outcomes (1)

• Post-bronchodilator FEVI

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

Secondary Outcomes (2)

• 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

Study Arms (2)

Placebo

PLACEBO COMPARATOR

po daily

Drug: Placebo

RAR Gamma

EXPERIMENTAL

5mg po daily

Drug: RAR Gamma

Interventions

Placebo DRUG

po daily

Placebo

RAR Gamma DRUG

5mg po daily

RAR Gamma

Eligibility Criteria

• Age: 44 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (64)

Unknown Facility

Birmingham, Alabama, 35299, United States

Location

Unknown Facility

Los Angeles, California, 90095-1690, United States

Location

Unknown Facility

San Diego, California, 92103, United States

Location

Unknown Facility

Torrance, California, 90502, United States

Location

Unknown Facility

Denver, Colorado, 80206, United States

Location

Unknown Facility

Chicago, Illinois, 60611, United States

Location

Unknown Facility

Detroit, Michigan, 48202-2689, United States

Location

Unknown Facility

Omaha, Nebraska, 68198-2465, United States

Location

Unknown Facility

Oklahoma City, Oklahoma, 73112, United States

Location

Unknown Facility

Philadelphia, Pennsylvania, 19140, United States

Location

Unknown Facility

Spartanburg, South Carolina, 29303, United States

Location

Unknown Facility

Houston, Texas, 77030, United States

Location

Unknown Facility

Pleven, 5800, Bulgaria

Location

Unknown Facility

Rousse, 7002, Bulgaria

Location

Unknown Facility

Sofia, 1431, Bulgaria

Location

Unknown Facility

Sofia, 1606, Bulgaria

Location

Unknown Facility

Brno, 390 03, Czechia

Location

Unknown Facility

Karlovy Vary, 360 09, Czechia

Location

Unknown Facility

Ostrava, 708 52, Czechia

Location

Unknown Facility

Prague, 150 06, Czechia

Location

Unknown Facility

Prague, 150 30, Czechia

Location

Unknown Facility

Prague, 180 01, Czechia

Location

Unknown Facility

Balassagyarmat, 2660, Hungary

Location

Unknown Facility

Budapest, 1036, Hungary

Location

Unknown Facility

Nyíregyháza, 4400, Hungary

Location

Unknown Facility

Pécs, 7635, Hungary

Location

Unknown Facility

Szombathely, 9700, Hungary

Location

Unknown Facility

Törökbálint, 2045, Hungary

Location

Unknown Facility

Reykjavik, 108, Iceland

Location

Unknown Facility

Ashkelon, 78306, Israel

Location

Unknown Facility

Haifa, 31096, Israel

Location

Unknown Facility

Petah Tikva, 49100, Israel

Location

Unknown Facility

Ramat Gan, 52621, Israel

Location

Unknown Facility

Rehovot, 76100, Israel

Location

Unknown Facility

Tel Aviv, 6423906, Israel

Location

Unknown Facility

Modena, Emilia-Romagna, 41100, Italy

Location

Unknown Facility

Genoa, Liguria, 16132, Italy

Location

Unknown Facility

Pavia, Lombardy, 27100, Italy

Location

Unknown Facility

Pisa, Tuscany, 56124, Italy

Location

Unknown Facility

Daugavpils, 5417, Latvia

Location

Unknown Facility

Riga, 1038, Latvia

Location

Unknown Facility

Riga, 2118, Latvia

Location

Unknown Facility

Riga, LV-1002, Latvia

Location

Unknown Facility

Bialystok, 15-003, Poland

Location

Unknown Facility

Katowice, 40-752, Poland

Location

Unknown Facility

Lodz, 92-215, Poland

Location

Unknown Facility

Poznan, 60-569, Poland

Location

Unknown Facility

Poznan, 60-693, Poland

Location

Unknown Facility

Warsaw, 01-138, Poland

Location

Unknown Facility

Warsaw, 04-730, Poland

Location

Unknown Facility

Bellville, South Africa

Location

Unknown Facility

Bloemfontein, 9301, South Africa

Location

Unknown Facility

Cape Town, 7925, South Africa

Location

Unknown Facility

Cape Town, 8001, South Africa

Location

Unknown Facility

Centurion, 0157, South Africa

Location

Unknown Facility

Durban, 4001, South Africa

Location

Unknown Facility

eManzimtoti, 4126, South Africa

Location

Unknown Facility

Johannesburg, 2006, South Africa

Location

Unknown Facility

Worcester, 6850, South Africa

Location

Unknown Facility

Donetsk, 83099, Ukraine

Location

Unknown Facility

Kiev, 01133, Ukraine

Location

Unknown Facility

Kiev, 03680, Ukraine

Location

Unknown Facility

Coventry, CV2 2DX, United Kingdom

Location

Unknown Facility

Liverpool, L9 7AL, United Kingdom

Location

MeSH Terms

Conditions

Emphysema

Interventions

Retinoic Acid Receptor gamma

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Receptors, Retinoic Acid; Receptors, Cytoplasmic and Nuclear; Proteins; Amino Acids, Peptides, and Proteins; Transcription Factors

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2006
• First Posted: December 19, 2006
• Study Start: January 1, 2007
• Primary Completion: May 1, 2010
• Study Completion: May 1, 2010
• Last Updated: November 2, 2016

Record last verified: 2016-11

Locations

HU (6); IC (1); LA (4); US (12); IT (4); BU (4); ZA (9); UA (3); GB (2); PL (7); CZ (6); IL (6)