Chronic Obstructive Pulmonary DiseasePhase 4REVASCNCT01595750
Randomized, Double-blind, Placebo-controlled Study to Evaluate the Effect of Roflumilast on Endothelial Function in Patients With Chronic Obstructive Pulmonary Disease
A Phase 4 study testing Roflumilast 500 in people with Chronic Obstructive Pulmonary Disease, run by Spanish Research Center for Respiratory Diseases at 1 site in Spain.
Trial summary
REVASC is a randomized, double-blind, placebo-controlled study which will involve 150 patients with chronic bronchitis and COPD diagnosed cardiovascular disease. The recruitment period beginimg in the coming weeks, will last nine months. Read more about this study
- Who is it for?
- Ages 55 to 75 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Roflumilast 500
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteSpain
- Study dates
- May 2012to Aug 2012
- Phase
- Phase 4
- 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 55 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed informed consent
- 55-75 years of age
- Current and former smokers >20 cigarettes pack-yr (if former smokers withdrawn >1 year)
- Diagnosis COPD (GOLD criteria1 for more than a year before V0)
- Presence of chronic bronchitis (cough and/or expectoration for more that 3 months/yr for more than 2 consecutive yrs. in the absence of other potential cause)
- Post-bronchodilator FEV1<70% reference
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- Presence of established CVD, CVD equivalent or diabetes mellitus
- Presence of chronic systemic inflammation, determined on:
- Serum CRP ≥ 2 and < 10 mg/l or
- Serum fibrinogen > 518 mg/dl and Leucocytes > 8,6*106 /mm3
Who cannot join
- Episode of COPD exacerbation and/or COPD treatment change during the last 2 months before V0
- History of asthma, significant residual lung lesions or bronchiectasis on chest x-ray
- Apnea-hypopnea syndrome
- Poorly controlled CVD risk factors (Table 2) and/or change in their treatment during the last 3 months before V0
- Clinically significant cardiac arrhythmias or valve disease
- Severe concomitant immunological, inflammatory, infectious or neoplastic diseases
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- Moderate or severe hepatic insufficiency (B or C class, following Child-Pugh scale)
- Severe neurologic and/or psychiatric disorder, including depression with suicidal ideas
- Alcohol and/or drug abuse during the last 12 months before V0
- Hypersensitivity to roflumilast or to any of its excipients
- Pregnancy or potential pregnancy
- Participation in other clinical trial during the last 30 days before V0
- Language difficulties to follow the instructions of the study
Trial locations and contacts
1 site in 1 country.
Spain1 site
Spanish Research Center for Respiratory Diseases
Bunyola, Balearic Island, 07110
Paloma Vaquer, 0034971011772, pvaquer@ciberes.org
About this study
REVASC is a randomized, double-blind, placebo-controlled study which will involve 150 patients with chronic bronchitis and COPD diagnosed cardiovascular disease. The recruitment period beginimg in the coming weeks, will last nine months. Patients included in the study will receive treatment for three months with roflumilast 500 mg (75 patients) or placebo (75 patients) in a randomized manner. The CIBERES, as promoter of this study is expected to release final results for the third quarter of 2013.
Eight centers in Madrid will be involved in this clinical trial: Fundación Jiménez Díaz, Hospital La Princesa, Hospital Gregorio Maranon Hospital Clinico San Carlos, Hospital La Paz, Hospital Ramón y Cajal Hospital Doce de Octubre and Hospital Puerta del Hierro.
Roflumilast is a potent phosphodiesterase-4 inhibitor (PDE4). Its clinical efficacy has been studied in an extensive clinical program involving over 12,000 patients with COPD. In these studies, roflumilast (in combination with long-acting bronchodilators) reduced the number of exacerbations and improved lung function, especially in those patients with associated chronic bronchitis.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Roflumilast 500, Placebo
- Keywords
- Post-bronchodilator FEV1<70% reference, Chronic bronchitis, Presence of estavlished CVD,, CVD equivalent or diabetes mellitus
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Bronchitis, Chronic, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Roflumilast 500Drug
Roflumilast 500 mcg , 12 weeks of treatment
PlaceboDrug
Placebo 500 mcg , 12 weeks of treatment
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| Roflumilast | Active comparator | Roflumilast 500 mcg Receives: Drug: Roflumilast 500 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endotelial function
Measured: 12 weeks
Secondary outcomes (4)
Arterial siffness
Measured: 12 weeks
Serum and plasma inflammation markers: (CRP, fibrinogen, leucocytes, interleukin (IL)-8, IL-6, IL-10, tumor necrosis factor alpha (TNFα), sICAM-1, MCP-1, PARC/CCL-18)
Measured: 12 weeks
Serum oxidatrive stress markers: MPO, TRX
Measured: 12 weeks
Serum endothelial dysfunction markers:TWEAKs, FasL, ADMA
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2012 (estimated)
- Study startMay 2012
- Primary completionJul 2012 (estimated)
- Study completionAug 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Spanish Research Center for Respiratory Diseases
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Julio Ancochea, Principal investigator, Fundación de Investigación Biomédica - Hospital Universitario de La PrincesaCarlos Álvarez, Principal investigator, Hospital Universitario Doce de OctubrePilar De Lucas, Principal investigator, Hospital General Universitario Gregorio MarañonMyriam Calle, Principal investigator, Hospital Clínico Universitario San CarlosSalvador Díaz, Principal investigator, Hospital Universitario Ramon y CajalFrancisco García, Principal investigator, Hospital Universitario La PazRosa Malo, Principal investigator, Hospital Universitario Puerta de HierroGermán Peces-Barba, Principal investigator, Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01595750
- Sponsor's protocol ID
- CIB-ROF-2011-01
- Other IDs
- 2011-005047-27
- Acronym
- REVASC
- Status last verified
- May 2012
- First submitted
- 9 May 2012
- Last updated
- 10 May 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-blind, Placebo-controlled Study to Evaluate the Effect of Roflumilast on Endothelial Function in Patients With Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT01595750
- Acronym / sponsor ID
- REVASC / CIB-ROF-2011-01
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- Post-bronchodilator FEV1<70% reference, Chronic bronchitis, Presence of estavlished CVD,, CVD equivalent or diabetes mellitus
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Spanish Research Center for Respiratory DiseasesUniversity, hospital or other
- Study start
- May 2012
- Primary completion
- Jul 2012 (estimated)
- Study completion
- Aug 2012 (estimated)
- First posted
- 10 May 2012 (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.
REVASC is a randomized, double-blind, placebo-controlled study which will involve 150 patients with chronic bronchitis and COPD diagnosed cardiovascular disease. The recruitment period beginimg in the coming weeks, will last nine months. Patients included in the study will receive treatment for three months with roflumilast 500 mg (75 patients) or placebo (75 patients) in a randomized manner. The CIBERES, as promoter of this study is expected to release final results for the third quarter of 2013.
Eight centers in Madrid will be involved in this clinical trial: Fundación Jiménez Díaz, Hospital La Princesa, Hospital Gregorio Maranon Hospital Clinico San Carlos, Hospital La Paz, Hospital Ramón y Cajal Hospital Doce de Octubre and Hospital Puerta del Hierro.
Roflumilast is a potent phosphodiesterase-4 inhibitor (PDE4). Its clinical efficacy has been studied in an extensive clinical program involving over 12,000 patients with COPD. In these studies, roflumilast (in combination with long-acting bronchodilators) reduced the number of exacerbations and improved lung function, especially in those patients with associated chronic bronchitis.
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: Placebo |
| Roflumilast | Active comparator | Drug: Roflumilast 500Roflumilast 500 mcg |
Who may qualify
- Ages
- 55 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Signed informed consent
- 55-75 years of age
- Current and former smokers >20 cigarettes pack-yr (if former smokers withdrawn >1 year)
- Diagnosis COPD (GOLD criteria1 for more than a year before V0)
- Presence of chronic bronchitis (cough and/or expectoration for more that 3 months/yr for more than 2 consecutive yrs. in the absence of other potential cause)
Key exclusion criteria (13 listed)
- Episode of COPD exacerbation and/or COPD treatment change during the last 2 months before V0
- History of asthma, significant residual lung lesions or bronchiectasis on chest x-ray
- Apnea-hypopnea syndrome
- Poorly controlled CVD risk factors (Table 2) and/or change in their treatment during the last 3 months before V0
- Clinically significant cardiac arrhythmias or valve disease
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 |
|---|---|---|
| Roflumilast 500Roflumilast 500 mcg , 12 weeks of treatment | Drug | Roflumilast |
| PlaceboPlacebo 500 mcg , 12 weeks of treatment | Drug | Placebo |
Primary outcome
Endotelial function
Time frame: 12 weeks
4 secondary outcomes
Arterial siffness
Time frame: 12 weeks
Serum and plasma inflammation markers: (CRP, fibrinogen, leucocytes, interleukin (IL)-8, IL-6, IL-10, tumor necrosis factor alpha (TNFα), sICAM-1, MCP-1, PARC/CCL-18)
Time frame: 12 weeks
Serum oxidatrive stress markers: MPO, TRX
Time frame: 12 weeks
Serum endothelial dysfunction markers:TWEAKs, FasL, ADMA
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2012.
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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.
Julio Ancochea principal investigator
Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
Carlos Álvarez principal investigator
Hospital Universitario Doce de Octubre
Pilar De Lucas principal investigator
Hospital General Universitario Gregorio Marañon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Roflumilast 500 in people with Chronic Obstructive Pulmonary Disease, run by Spanish Research Center for Respiratory Diseases at 1 site in Spain.
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 10 inclusion and 13 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: status not confirmed, as of the sponsor's last update on 10 May 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Àlvar Agustí (971 011 772, info@ciberes.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Endotelial function (time frame: 12 weeks). 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 10 May 2012; AzTrials last refreshed its copy on 4 Nov 2026.