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

Emphysema Clinical Trial

Official 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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00413205
• Other study ID #: NB19751
• Status: Completed
• Phase: Phase 2
• First received: December 18, 2006
• Last updated: November 1, 2016
• Start date: January 2007
• Est. completion date: May 2010

Study information

• Verified date: November 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 491
• Est. completion date: May 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 44 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Emphysema
• Pulmonary Emphysema

Intervention

Drug:
• Placebo
po daily
• RAR Gamma
5mg po daily

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

United States,  Bulgaria,  Czech Republic,  Hungary,  Iceland,  Israel,  Italy,  Latvia,  Poland,  South Africa,  Ukraine,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post-bronchodilator FEVI		At intervals throughout study, and 2 and 6 months after cessation of study drug	No
Secondary	DLCo, lung densitometry, SGRQ, lung volume, walk test, time to first COPD exacerbation.		At intervals throughout study	No
Secondary	AEs, SAEs, retinoid side effects, lab parameters.		Thoughout study	No