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

NCT01595750 | Unknown Phase 4

• 2 other identifiers: CIB-ROF-2011-012011-005047-27
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Endotelial function

  12 weeks

Secondary Outcomes (4)

• Arterial siffness

  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)

  12 weeks

• Serum oxidatrive stress markers: MPO, TRX

  12 weeks

• Serum endothelial dysfunction markers:TWEAKs, FasL, ADMA

  12 weeks

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Roflumilast

ACTIVE COMPARATOR

Roflumilast 500 mcg

Drug: Roflumilast 500

Interventions

Roflumilast 500 DRUG

Roflumilast 500 mcg , 12 weeks of treatment

Roflumilast

Placebo DRUG

Placebo 500 mcg , 12 weeks of treatment

Placebo

Eligibility Criteria

• Age: 55 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed informed consent
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Spanish Research Center for Respiratory Diseases: lead

Study Sites (1)

Spanish Research Center for Respiratory Diseases

Bunyola, Balearic Island, 07110, Spain

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Bronchitis, Chronic; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Bronchitis; Respiratory Tract Infections; Infections; Bronchial Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• 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

  Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Àlvar Agustí

CONTACT

971 011 772; info@ciberes.org

Paloma Vaquer

CONTACT

971 011 772; pvaquer@ciberes.org

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2012
• First Posted: May 10, 2012
• Study Start: May 1, 2012
• Primary Completion: July 1, 2012
• Study Completion: August 1, 2012
• Last Updated: May 10, 2012

Record last verified: 2012-05

Locations

ES (1)