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

Chronic Obstructive Pulmonary Disease Clinical Trial

— 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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01595750
• Other study ID #: CIB-ROF-2011-01
• Secondary ID: 2011-005047-27
• Status: Not yet recruiting
• Phase: Phase 4
• First received: May 9, 2012
• Last updated: May 9, 2012
• Start date: May 2012
• Est. completion date: August 2012

Study information

• Verified date: May 2012
• Source: Spanish Research Center for Respiratory Diseases
• Contact: Àlvar Agustí
• Phone: 971 011 772
• Email: info[@]ciberes.org
• Is FDA regulated: No
• Health authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 150
• Est. completion date: August 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 55 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• Roflumilast 500
Roflumilast 500 mcg , 12 weeks of treatment
• Placebo
Placebo 500 mcg , 12 weeks of treatment

Locations

Country	Name	City	State
Spain	Spanish Research Center for Respiratory Diseases	Bunyola	Balearic Island

Sponsors (1)

Lead Sponsor	Collaborator
Spanish Research Center for Respiratory Diseases

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Endotelial function		12 weeks	No
Secondary	Arterial siffness		12 weeks	No
Secondary	Serum and plasma inflammation markers: (CRP, fibrinogen, leucocytes, interleukin (IL)-8, IL-6, IL-10, tumor necrosis factor alpha (TNFa), sICAM-1, MCP-1, PARC/CCL-18)		12 weeks	No
Secondary	Serum oxidatrive stress markers: MPO, TRX		12 weeks	No
Secondary	Serum endothelial dysfunction markers:TWEAKs, FasL, ADMA		12 weeks	No