Back to resultsTESRA: (Treatment of Emphysema With a Gamma-Selective Retinoid Agonist)
Primary Purpose
Emphysema
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Placebo
RAR Gamma
Sponsored by
About this trial
This is an interventional treatment trial for Emphysema
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Placebo
RAR Gamma
Arm Description
po daily
5mg po daily
Outcomes
Primary Outcome Measures
Post-bronchodilator FEVI
Secondary Outcome Measures
DLCo, lung densitometry, SGRQ, lung volume, walk test, time to first COPD exacerbation.
AEs, SAEs, retinoid side effects, lab parameters.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00413205
Brief Title
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
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
January 2007 (undefined)
Primary Completion Date
May 2010 (Actual)
Study Completion Date
May 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Emphysema
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
491 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
po daily
Arm Title
RAR Gamma
Arm Type
Experimental
Arm Description
5mg po daily
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
po daily
Intervention Type
Drug
Intervention Name(s)
RAR Gamma
Intervention Description
5mg po daily
Primary Outcome Measure Information:
Title
Post-bronchodilator FEVI
Time Frame
At intervals throughout study, and 2 and 6 months after cessation of study drug
Secondary Outcome Measure Information:
Title
DLCo, lung densitometry, SGRQ, lung volume, walk test, time to first COPD exacerbation.
Time Frame
At intervals throughout study
Title
AEs, SAEs, retinoid side effects, lab parameters.
Time Frame
Thoughout study
10. Eligibility
Sex
All
Minimum Age & Unit of Time
44 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35299
Country
United States
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095-1690
Country
United States
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
City
Torrance
State/Province
California
ZIP/Postal Code
90502
Country
United States
City
Denver
State/Province
Colorado
ZIP/Postal Code
80206
Country
United States
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202-2689
Country
United States
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198-2465
Country
United States
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19140
Country
United States
City
Spartanburg
State/Province
South Carolina
ZIP/Postal Code
29303
Country
United States
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
City
Pleven
ZIP/Postal Code
5800
Country
Bulgaria
City
Ruse
ZIP/Postal Code
7002
Country
Bulgaria
City
Sofia
ZIP/Postal Code
1431
Country
Bulgaria
City
Sofia
ZIP/Postal Code
1606
Country
Bulgaria
City
Brno
ZIP/Postal Code
390 03
Country
Czech Republic
City
Karlovy Vary
ZIP/Postal Code
360 09
Country
Czech Republic
City
Ostrava
ZIP/Postal Code
708 52
Country
Czech Republic
City
Praha 5
ZIP/Postal Code
150 30
Country
Czech Republic
City
Praha
ZIP/Postal Code
150 06
Country
Czech Republic
City
Praha
ZIP/Postal Code
180 01
Country
Czech Republic
City
Balassagyarmat
ZIP/Postal Code
2660
Country
Hungary
City
Budapest
ZIP/Postal Code
1036
Country
Hungary
City
Nyiregyhaza
ZIP/Postal Code
4400
Country
Hungary
City
Pecs
ZIP/Postal Code
7635
Country
Hungary
City
Szombathely
ZIP/Postal Code
9700
Country
Hungary
City
Torokbalint
ZIP/Postal Code
2045
Country
Hungary
City
Reykjavik
ZIP/Postal Code
108
Country
Iceland
City
Ashkelon
ZIP/Postal Code
78306
Country
Israel
City
Haifa
ZIP/Postal Code
31096
Country
Israel
City
Petach Tikva
ZIP/Postal Code
49100
Country
Israel
City
Ramat Gan
ZIP/Postal Code
52621
Country
Israel
City
Rehovot
ZIP/Postal Code
76100
Country
Israel
City
Tel Aviv
ZIP/Postal Code
6423906
Country
Israel
City
Modena
State/Province
Emilia-Romagna
ZIP/Postal Code
41100
Country
Italy
City
Genova
State/Province
Liguria
ZIP/Postal Code
16132
Country
Italy
City
Pavia
State/Province
Lombardia
ZIP/Postal Code
27100
Country
Italy
City
Pisa
State/Province
Toscana
ZIP/Postal Code
56124
Country
Italy
City
Daugavpils
ZIP/Postal Code
5417
Country
Latvia
City
Riga
ZIP/Postal Code
1038
Country
Latvia
City
Riga
ZIP/Postal Code
2118
Country
Latvia
City
Riga
ZIP/Postal Code
LV-1002
Country
Latvia
City
Bialystok
ZIP/Postal Code
15-003
Country
Poland
City
Katowice
ZIP/Postal Code
40-752
Country
Poland
City
Lodz
ZIP/Postal Code
92-215
Country
Poland
City
Poznan
ZIP/Postal Code
60-569
Country
Poland
City
Poznan
ZIP/Postal Code
60-693
Country
Poland
City
Warszawa
ZIP/Postal Code
01-138
Country
Poland
City
Warszawa
ZIP/Postal Code
04-730
Country
Poland
City
Amanzimtoti
ZIP/Postal Code
4126
Country
South Africa
City
Bellville
Country
South Africa
City
Bloemfontein
ZIP/Postal Code
9301
Country
South Africa
City
Cape Town
ZIP/Postal Code
7925
Country
South Africa
City
Cape Town
ZIP/Postal Code
8001
Country
South Africa
City
Centurion
ZIP/Postal Code
0157
Country
South Africa
City
Durban
ZIP/Postal Code
4001
Country
South Africa
City
Johannesburg
ZIP/Postal Code
2006
Country
South Africa
City
Worcester
ZIP/Postal Code
6850
Country
South Africa
City
Donetsk
ZIP/Postal Code
83099
Country
Ukraine
City
Kiev
ZIP/Postal Code
01133
Country
Ukraine
City
Kiev
ZIP/Postal Code
03680
Country
Ukraine
City
Coventry
ZIP/Postal Code
CV2 2DX
Country
United Kingdom
City
Liverpool
ZIP/Postal Code
L9 7AL
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
TESRA: (Treatment of Emphysema With a Gamma-Selective Retinoid Agonist)
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