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. The completion date has passed and the status has not been verified in more than two years.

Verified May 2012 by Spanish Research Center for Respiratory Diseases.
Recruitment status was: Not yet recruiting

Sponsor:

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

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 Intervention Model: Parallel Assignment Masking: Double Blind (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

Resource links provided by NLM:

MedlinePlus related topics: COPD Lung Diseases

Drug Information available for: Roflumilast

U.S. FDA Resources

Further study details as provided by Spanish Research Center for Respiratory Diseases:

Primary Outcome Measures:

Endotelial function [ Time Frame: 12 weeks ]

Secondary Outcome Measures:

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 ]


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)
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

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

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 ( EudraCT Number )
Study First Received:	May 9, 2012
Last Updated:	May 9, 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

ClinicalTrials.gov processed this record on June 22, 2017

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