Effects of ROFLUMILAST on Subclinical Atherosclerosis in Chronic Obstructive Pulmonary Disease (COPD)

Conditions

• Chronic Obstructive Pulmonary Disease and Allied Conditions

Eligibility Criteria

Sex

ALL

Age

40 Years - 80 Years

Healthy Volunteers

Not accepted

Interventions

• Roflumilast — DRUG
  Roflumilast coated tablet, 500µg oral application, once daily in the morning
• Placebo — DRUG
  Placebo coated tablet (visually identical to 500µg Roflumilast tablet), oral application, once daily in the morning

Study Details

Chronic obstructive pulmonary disease is associated with a low grade systemic inflammatory process. Systemic inflammation is hypothesized to maintain cardiovascular morbidity and mortality in COPD. Early changes of vascular integrity can be detected via markers of subclinical atherosclerosis. Selective Inhibition of phosphodiesterase subtype 4 describes a promising therapeutic option in COPD with beneficial impact on lung function and exacerbation rate. Moreover, an anti-inflammatory effect of phosphodiesterase-4 inhibition was confirmed by recent data. The aim of this study is to assess the effects of the phosphodiesterase-4 inhibitor Roflumilast on firstly surrogates of subclinical atherosclerosis and secondly markers of systemic inflammation in the peripheral circulation of patients with stable chronic obstructive pulmonary disease.

Key Dates

Start date

May 31, 2012

Status verified

Jan 2019

Primary completion

Jan 31, 2016

Completion

Jan 31, 2016

Study Design

Enrollment

80 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: Roflumilast
  Active arm including patients who receive the study drug (500µg Roflumilast once daily)
• Placebo Comparator: Placebo
  Control arm including patients who receive the placebo tablet (once daily)

Primary Outcome Measure

Change From Baseline in Carotid Femoral-Pulse Wave Velocity at Month 6 [ Time Frame: baseline, month 6 ]