Clinical trial NCT00413205: TESRA: (Treatment of Emphysema With a Gamma-Selective Retinoid Agonist)
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Emphysema
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2006-12-19
Enrollment: 491
Sex: ALL
Minimum age (years): 44
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Post-bronchodilator FEVI
timeFrame: At intervals throughout study, and 2 and 6 months after cessation of study drug
Secondary outcomes:
measure: DLCo, lung densitometry, SGRQ, lung volume, walk test, time to first COPD exacerbation.
timeFrame: At intervals throughout study
measure: AEs, SAEs, retinoid side effects, lab parameters.
timeFrame: Thoughout study
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: Los Angeles
country: United States
state: California
city: San Diego
country: United States
state: California
city: Torrance
country: United States
state: California
city: Denver
country: United States
state: Colorado
city: Chicago
country: United States
state: Illinois
city: Detroit
country: United States
state: Michigan
city: Omaha
country: United States
state: Nebraska
city: Oklahoma City
country: United States
state: Oklahoma
city: Philadelphia
country: United States
state: Pennsylvania
city: Spartanburg
country: United States
state: South Carolina
city: Houston
country: United States
state: Texas
city: Pleven
country: Bulgaria
city: Ruse
country: Bulgaria
city: Sofia
country: Bulgaria
city: Sofia
country: Bulgaria
city: Brno
country: Czech Republic
city: Karlovy Vary
country: Czech Republic
city: Ostrava
country: Czech Republic
city: Praha 5
country: Czech Republic
city: Praha
country: Czech Republic
city: Praha
country: Czech Republic
city: Balassagyarmat
country: Hungary
city: Budapest
country: Hungary
city: Nyiregyhaza
country: Hungary
city: Pecs
country: Hungary
city: Szombathely
country: Hungary
city: Torokbalint
country: Hungary
city: Reykjavik
country: Iceland
city: Ashkelon
country: Israel
city: Haifa
country: Israel
city: Petach Tikva
country: Israel
city: Ramat Gan
country: Israel
city: Rehovot
country: Israel
city: Tel Aviv
country: Israel
city: Modena
country: Italy
state: Emilia-Romagna
city: Genova
country: Italy
state: Liguria
city: Pavia
country: Italy
state: Lombardia
city: Pisa
country: Italy
state: Toscana
city: Daugavpils
country: Latvia
city: Riga
country: Latvia
city: Riga
country: Latvia
city: Riga
country: Latvia
city: Bialystok
country: Poland
city: Katowice
country: Poland
city: Lodz
country: Poland
city: Poznan
country: Poland
city: Poznan
country: Poland
city: Warszawa
country: Poland
city: Warszawa
country: Poland
city: Amanzimtoti
country: South Africa
city: Bellville
country: South Africa
city: Bloemfontein
country: South Africa
city: Cape Town
country: South Africa
city: Cape Town
country: South Africa
city: Centurion
country: South Africa
city: Durban
country: South Africa
city: Johannesburg
country: South Africa
city: Worcester
country: South Africa
city: Donetsk
country: Ukraine
city: Kiev
country: Ukraine
city: Kiev
country: Ukraine
city: Coventry
country: United Kingdom
city: Liverpool
country: United Kingdom
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: