Conditions: Chronic Obstructive Pulmonary Disease and Allied Conditions
Keywords: COPD comorbidity arterial stiffness roflumilast
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 80
Healthy volunteers: no

Brief summary:
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.

Detailed description:

Arms:
arm 1: Active arm including patients who receive the study drug (500µg Roflumilast once daily) arm 2: Control arm including patients who receive the placebo tablet (once daily)

Interventions: intervention 1: Roflumilast intervention 2: Placebo
Intervention descriptions: intervention 1: Roflumilast coated tablet, 500µg oral application, once daily in the morning intervention 2: Placebo coated tablet (visually identical to 500µg Roflumilast tablet), oral application, once daily in the morning

Protocol document: