Know Cancer

or
forgot password

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


Phase 4
55 Years
75 Years
Not Enrolling
Both
Chronic Obstructive Pulmonary Disease

Thank you

Trial Information

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


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20 cigarettes pack-yr (if former smokers withdrawn 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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Endotelial function

Outcome Time Frame:

12 weeks

Safety Issue:

No

Principal Investigator

Julio Ancochea

Investigator Role:

Principal Investigator

Investigator Affiliation:

Hospital Universitario La Princesa

Authority:

Spain: Agencia Española de Medicamentos y Productos Sanitarios

Study ID:

CIB-ROF-2011-01

NCT ID:

NCT01595750

Start Date:

May 2012

Completion Date:

August 2012

Related Keywords:

  • Chronic Obstructive Pulmonary Disease
  • Post-bronchodilator FEV1<70% reference
  • Chronic bronchitis
  • Presence of estavlished CVD,
  • CVD equivalent or diabetes mellitus
  • Lung Diseases
  • Respiration Disorders
  • Pulmonary Disease, Chronic Obstructive
  • Lung Diseases, Obstructive

Name

Location