NCT01630200

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

Effects of ROFLUMILAST on Markers of Subclinical Atherosclerosis In Stable COPD; the ELASTIC-trial

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: LudwLudwig Boltzmann Institute for COPD and Respiratory Epidemiology · Network
• Sex: All
• Age: 40 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Obstructive Pulmonary Disease and Allied Conditions

Interventions

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

Timeline

• Start date: 2012-05-01
• Primary completion: 2016-01-01
• Completion: 2016-01-01
• First posted: 2012-06-28
• Last updated: 2019-04-12
• Results posted: 2019-04-12

Locations

1 site across 1 country: Austria