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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20 cigarettes pack-yr (if former smokers withdrawn 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


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
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