EmphysemaPhase 2NCT00413205
TESRA: (Treatment of Emphysema With a Gamma-Selective Retinoid Agonist)
A Phase 2 study testing RAR Gamma in people with Emphysema, run by Hoffmann-La Roche at 64 sites in 12 countries.
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. Read more about this study
- Who is it for?
- Ages 44 years and older
- Conditions the study is for
- Emphysema
- What is being tested?
- RAR Gamma
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 491 participants
- Where
- 64 sitesin 12 countries
- Study dates
- Jan 2007to May 2010
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 44 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
64 sites in 12 countries.
64 sites in 12 countries
United States12 sites
Study site
Birmingham, Alabama, 35299
Study site
Chicago, Illinois, 60611
Study site
Denver, Colorado, 80206
Study site
Detroit, Michigan, 48202-2689
Study site
Houston, Texas, 77030
Study site
Los Angeles, California, 90095-1690
Study site
Oklahoma City, Oklahoma, 73112
Study site
Omaha, Nebraska, 68198-2465
Study site
Philadelphia, Pennsylvania, 19140
Study site
San Diego, California, 92103
Study site
Spartanburg, South Carolina, 29303
Study site
Torrance, California, 90502
South Africa9 sites
Study site
Bellville
Study site
Bloemfontein, 9301
Study site
Cape Town, 7925
Study site
Cape Town, 8001
Study site
Centurion, 0157
Study site
Durban, 4001
Study site
eManzimtoti, 4126
Study site
Johannesburg, 2006
Study site
Worcester, 6850
Poland7 sites
Study site
Bialystok, 15-003
Study site
Katowice, 40-752
Study site
Lodz, 92-215
Study site
Poznan, 60-569
Study site
Poznan, 60-693
Study site
Warsaw, 01-138
Study site
Warsaw, 04-730
Czechia6 sites
Study site
Brno, 390 03
Study site
Karlovy Vary, 360 09
Study site
Ostrava, 708 52
Study site
Prague, 150 06
Study site
Prague, 150 30
Study site
Prague, 180 01
Hungary6 sites
Study site
Balassagyarmat, 2660
Study site
Budapest, 1036
Study site
Nyíregyháza, 4400
Study site
Pécs, 7635
Study site
Szombathely, 9700
Study site
Törökbálint, 2045
Israel6 sites
Study site
Ashkelon, 78306
Study site
Haifa, 31096
Study site
Petah Tikva, 49100
Study site
Ramat Gan, 52621
Study site
Rehovot, 76100
Study site
Tel Aviv, 6423906
Bulgaria4 sites
Study site
Pleven, 5800
Study site
Rousse, 7002
Study site
Sofia, 1431
Study site
Sofia, 1606
Italy4 sites
Study site
Genoa, Liguria, 16132
Study site
Modena, Emilia-Romagna, 41100
Study site
Pavia, Lombardy, 27100
Study site
Pisa, Tuscany, 56124
Latvia4 sites
Study site
Daugavpils, 5417
Study site
Riga, 1038
Study site
Riga, 2118
Study site
Riga, LV-1002
Ukraine3 sites
Study site
Donetsk, 83099
Study site
Kiev, 01133
Study site
Kiev, 03680
United Kingdom2 sites
Study site
Coventry, CV2 2DX
Study site
Liverpool, L9 7AL
About this study
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.
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
- Being tested
- Placebo, RAR Gamma
- Medical subject headings
- Emphysema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
po daily
RAR GammaDrug
5mg po daily
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | po daily Receives: Drug: Placebo |
| RAR Gamma | Experimental | 5mg po daily Receives: Drug: RAR Gamma |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-bronchodilator FEVI
Measured: 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.
Measured: At intervals throughout study
AEs, SAEs, retinoid side effects, lab parameters.
Measured: Thoughout study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2006 (estimated)
- Study startJan 2007
- Primary completionMay 2010
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EmphysemaStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 491 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00413205
- Sponsor's protocol ID
- NB19751
- Status last verified
- Nov 2016
- First submitted
- 18 Dec 2006
- Last updated
- 2 Nov 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00413205
- Acronym / sponsor ID
- NB19751
- Conditions
- Emphysema
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 491 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- Jan 2007
- Primary completion
- May 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 19 Dec 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebopo daily |
| RAR Gamma | Experimental | Drug: RAR Gamma5mg po daily |
Who may qualify
- Ages
- 44 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Placebopo daily | Drug | Placebo |
| RAR Gamma5mg po daily | Drug | RAR Gamma |
Primary outcome
Post-bronchodilator FEVI
Time frame: At intervals throughout study, and 2 and 6 months after cessation of study drug
2 secondary outcomes
DLCo, lung densitometry, SGRQ, lung volume, walk test, time to first COPD exacerbation.
Time frame: At intervals throughout study
AEs, SAEs, retinoid side effects, lab parameters.
Time frame: Thoughout study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trials study director
Hoffmann-La Roche
64 sites in 12 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing RAR Gamma in people with Emphysema, run by Hoffmann-La Roche at 64 sites in 12 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 64 sites in United States, South Africa, Poland, Czechia, Hungary and 7 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-bronchodilator FEVI (time frame: At intervals throughout study, and 2 and 6 months after cessation of study drug). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2016.