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

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

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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, Senior)
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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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations 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 ( EudraCT Number )
First Posted:	May 10, 2012
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:

Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Respiratory Tract Diseases