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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)

Primary Purpose

Chronic Obstructive Pulmonary Disease

Status

Unknown status

Phase

Phase 4

Locations

Spain

Study Type

Interventional

Intervention

Roflumilast 500

Placebo

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease focused on measuring Post-bronchodilator FEV1<70% reference, Chronic bronchitis, Presence of estavlished CVD,, CVD equivalent or diabetes mellitus

Eligibility Criteria

55 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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20 cigarettes pack-yr (if former smokers withdrawn 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

Sites / Locations

Spanish Research Center for Respiratory Diseases

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Placebo

Roflumilast

Arm Description

Roflumilast 500 mcg

Outcomes

Primary Outcome Measures

Endotelial function

Secondary Outcome Measures

Arterial siffness

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)

Serum oxidatrive stress markers: MPO, TRX

Serum endothelial dysfunction markers:TWEAKs, FasL, ADMA

Full Information

NCT ID

NCT01595750

First Posted

May 9, 2012

Last Updated

May 9, 2012

Sponsor

Spanish Research Center for Respiratory Diseases

1. Study Identification

Unique Protocol Identification Number

NCT01595750

Brief Title

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

Acronym

REVASC

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 Type

Interventional

2. Study Status

Record Verification Date

May 2012

Overall Recruitment Status

Unknown status

Study Start Date

May 2012 (undefined)

Primary Completion Date

July 2012 (Anticipated)

Study Completion Date

August 2012 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Spanish Research Center for Respiratory Diseases

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Obstructive Pulmonary Disease

Keywords

Post-bronchodilator FEV1<70% reference, Chronic bronchitis, Presence of estavlished CVD,, CVD equivalent or diabetes mellitus

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Title

Roflumilast

Arm Type

Active Comparator

Arm Description

Roflumilast 500 mcg

Intervention Type

Drug

Intervention Name(s)

Roflumilast 500

Intervention Description

Roflumilast 500 mcg , 12 weeks of treatment

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Placebo 500 mcg , 12 weeks of treatment

Primary Outcome Measure Information:

Title

Endotelial function

Time Frame

12 weeks

Secondary Outcome Measure Information:

Title

Arterial siffness

Time Frame

12 weeks

Title

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

Title

Serum oxidatrive stress markers: MPO, TRX

Time Frame

12 weeks

Title

Serum endothelial dysfunction markers:TWEAKs, FasL, ADMA

Time Frame

12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

55 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Àlvar Agustí

Phone

971 011 772

info@ciberes.org

First Name & Middle Initial & Last Name or Official Title & Degree

Paloma Vaquer

Phone

971 011 772

pvaquer@ciberes.org

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Julio Ancochea

Organizational Affiliation

Hospital Universitario La Princesa

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Carlos Álvarez

Organizational Affiliation

Hospital Universitario Doce de Octubre

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Pilar De Lucas

Organizational Affiliation

Hospital General Universitario Gregorio Marañón

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Myriam Calle

Organizational Affiliation

Hospital Clínico Universitario San Carlos

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Salvador Díaz

Organizational Affiliation

Hospital Universitario Ramón y Cajal

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Francisco García

Organizational Affiliation

Hospital Universitario La Paz

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Rosa Malo

Organizational Affiliation

Hospital Universitario Puerta de Hierro

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Germán Peces-Barba

Organizational Affiliation

Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz

Official's Role

Principal Investigator

Facility Information:

Facility Name

Spanish Research Center for Respiratory Diseases

City

Bunyola

State/Province

Balearic Island

ZIP/Postal Code

07110

Country

Spain

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Paloma Vaquer

Phone

0034971011772

pvaquer@ciberes.org

12. IPD Sharing Statement

Learn more about this trial

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

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