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Randomized, Double-blind, Placebo-controlled Study to Evaluate the Effect of Roflumilast on Endothelial Function in Patients With Chronic Obstructive Pulmonary Disease (REVASC)

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ClinicalTrials.gov Identifier: NCT01595750
Recruitment Status : Unknown
Verified May 2012 by Spanish Research Center for Respiratory Diseases.
Recruitment status was:  Not yet recruiting
First Posted : May 10, 2012
Last Update Posted : May 10, 2012
Sponsor:
Information provided by (Responsible Party):
Spanish Research Center for Respiratory Diseases

Study Description
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Brief 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. 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 or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease Drug: Roflumilast 500 Drug: Placebo Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : May 2012
Estimated Primary Completion Date : July 2012
Estimated Study Completion Date : August 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COPD Lung Diseases
Drug Information available for: Roflumilast

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Endotelial function [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. Arterial siffness [ Time Frame: 12 weeks ]
  2. 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 ]
  3. Serum oxidatrive stress markers: MPO, TRX [ Time Frame: 12 weeks ]
  4. Serum endothelial dysfunction markers:TWEAKs, FasL, ADMA [ Time Frame: 12 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   55 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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:

    1. Serum CRP ≥ 2 and < 10 mg/l or
    2. 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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01595750


Contacts
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Contact: Àlvar Agustí 971 011 772 info@ciberes.org
Contact: Paloma Vaquer 971 011 772 pvaquer@ciberes.org

Locations
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Spain
Spanish Research Center for Respiratory Diseases
Bunyola, Balearic Island, Spain, 07110
Contact: Paloma Vaquer    0034971011772    pvaquer@ciberes.org   
Sponsors and Collaborators
Spanish Research Center for Respiratory Diseases
Investigators
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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
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Responsible Party: Spanish Research Center for Respiratory Diseases
ClinicalTrials.gov Identifier: NCT01595750    
Other Study ID Numbers: CIB-ROF-2011-01
2011-005047-27 ( EudraCT Number )
First Posted: May 10, 2012    Key Record Dates
Last Update Posted: May 10, 2012
Last Verified: May 2012
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:
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Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases