Trial information

TESRA: (Treatment of Emphysema with a gamma-Selective Retinoid Agonist)

Status: No longer recruiting

Protocol number: NB19751

Sponsor: Hoffmann-La Roche

Company division: Pharmaceutical

Official Scientific 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.

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. Target sample size is 480.

Study phase: II

Study type: Interventional; Treatment; Randomized; Double Blind; Placebo; Parallel; Safety/Efficacy study

Condition: Emphysema

Intervention type: Drug

Intervention name: RAR Gamma

Primary outcome: 1. Post-bronchodilator FEVI Time frame: At intervals throughout study, and 2 and 6 months after cessation of study drug

Key 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

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.

Gender: Males or Females

Age limits: Min: 44 Years Max: N/A (No limit)

Accepts healthy volunteers: No

Anticipated start date: February, 2007

Trial registration date: 12/18/2006

Date last updated: 11/21/2008

Link to trial result

This trial was conducted at the following locations:

Bulgaria

• Pleven
• Ruse
• Sofia

Czech Republic

• Karlovy Vary
• Ostrava
• Praha
• Tabor

Hungary

• Balassagyarmat
• Budapest
• Pecs
• Szombathely
• Torokbalint

Iceland

• Reykjavik

Israel

• Ashkelon
• Haifa
• Petah Tikva
• Ramat Gan
• Rehovot
• Tel Aviv

Italy

• Genova
• Modena
• Pavia
• Pisa

Latvia

• Daugavpils
• Riga

Poland

• Bialystok
• Katowice
• Lodz
• Poznan
• Warszawa

South Africa

• Amanzimtoti
• Bellville
• Bloemfontein
• Cape Town
• Centurion
• Durban
• Worcester

Ukraine

• Donetsk
• Kiev

United Kingdom

• Coventry

United States

• Birmingham, AL
• Los Angeles, CA
• San Diego , CA
• Torrance , CA
• Denver, CO
• Chicago, IL
• Detroit, MI
• Omaha, NE
• Oklahoma City, OK
• Philadelphia, PA
• Spartanburg, SC
• Houston, TX