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

NCT01630200 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2019-04-12

Study results available
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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

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

Sponsors & Collaborators

  • Medical University of Vienna

    collaborator OTHER

  • LudwLudwig Boltzmann Institute for COPD and Respiratory Epidemiology

    lead NETWORK

Principal Investigators

  • Otto C Burghuber, M.D. · Department for Respiratory and Critical Care Medicine, Otto Wagner Hospital, Vienna

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-05-31
Primary Completion
2016-01-31
Completion
2016-01-31

Countries

  • Austria

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01630200 on ClinicalTrials.gov