Randomized, Double-blind, Placebo-controlled Study to Evaluate the Effect of Roflumilast on Endothelial Function in Patients With Chronic Obstructive Pulmonary Disease (REVASC)
The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2012 by Spanish Research Center for Respiratory Diseases.
Recruitment status was Not yet recruiting
Recruitment status was Not yet recruiting
Sponsor:
Spanish Research Center for Respiratory Diseases
Information provided by (Responsible Party):
Spanish Research Center for Respiratory Diseases
ClinicalTrials.gov Identifier:
NCT01595750
First received: May 9, 2012
Last updated: NA
Last verified: May 2012
History: No changes posted
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Chronic Obstructive Pulmonary Disease |
Drug: Roflumilast 500 Drug: Placebo |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | Randomized, Double-blind, Placebo-controlled Study to Evaluate the Effect of Roflumilast on Endothelial Function in Patients With Chronic Obstructive Pulmonary Disease |
Resource links provided by NLM:
Further study details as provided by Spanish Research Center for Respiratory Diseases:
Primary Outcome Measures:
- Endotelial function [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Arterial siffness [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- Serum oxidatrive stress markers: MPO, TRX [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- Serum endothelial dysfunction markers:TWEAKs, FasL, ADMA [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 150 |
| Study Start Date: | May 2012 |
| Estimated Study Completion Date: | August 2012 |
| Estimated Primary Completion Date: | July 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Placebo Comparator: Placebo |
Drug: Placebo
Placebo 500 mcg , 12 weeks of treatment
|
|
Active Comparator: Roflumilast
Roflumilast 500 mcg
|
Drug: Roflumilast 500
Roflumilast 500 mcg , 12 weeks of treatment
|
Eligibility| Ages Eligible for Study: | 55 Years to 75 Years (Adult, Senior) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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
- 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
Exclusion Criteria:
- 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
- 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
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01595750
Please refer to this study by its ClinicalTrials.gov identifier: NCT01595750
Contacts
| Contact: Àlvar Agustí | 971 011 772 | info@ciberes.org | |
| Contact: Paloma Vaquer | 971 011 772 | pvaquer@ciberes.org |
Locations
| Spain | |
| Spanish Research Center for Respiratory Diseases | Not yet recruiting |
| Bunyola, Balearic Island, Spain, 07110 | |
| Contact: Paloma Vaquer 0034971011772 pvaquer@ciberes.org | |
Sponsors and Collaborators
Spanish Research Center for Respiratory Diseases
Investigators
| Principal Investigator: | Julio Ancochea | Hospital Universitario La Princesa |
| Principal Investigator: | Carlos Álvarez | Hospital Universitario Doce de Octubre |
| Principal Investigator: | Pilar De Lucas | Hospital General Universitario Gregorio Marañón |
| Principal Investigator: | Myriam Calle | Hospital Clínico Universitario San Carlos |
| Principal Investigator: | Salvador Díaz | Hospital Universitario Ramón y Cajal |
| Principal Investigator: | Francisco García | Hospital Universitario La Paz |
| Principal Investigator: | Rosa Malo | Hospital Universitario Puerta de Hierro |
| Principal Investigator: | Germán Peces-Barba | Fundación Jiménez Díaz |
More Information
| Responsible Party: | Spanish Research Center for Respiratory Diseases |
| ClinicalTrials.gov Identifier: | NCT01595750 History of Changes |
| Other Study ID Numbers: | CIB-ROF-2011-01 2011-005047-27 |
| Study First Received: | May 9, 2012 |
| Last Updated: | May 9, 2012 |
| Health Authority: | Spain: Agencia Española de Medicamentos y Productos Sanitarios |
Keywords provided by Spanish Research Center for Respiratory Diseases:
|
Post-bronchodilator FEV1<70% reference Chronic bronchitis Presence of estavlished CVD, CVD equivalent or diabetes mellitus |
Additional relevant MeSH terms:
|
Lung Diseases Lung Diseases, Obstructive Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases |
ClinicalTrials.gov processed this record on September 23, 2016