This trial is active, not recruiting.

Condition chronic obstructive pulmonary disease and allied conditions
Treatments roflumilast, placebo
Phase phase 2
Sponsor LudwLudwig Boltzmann Institute for COPD and Respiratory Epidemiology
Collaborator Medical University of Vienna
Start date May 2012
End date January 2016
Trial size 80 participants
Trial identifier NCT01630200, ELASTIC2011


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator, outcomes assessor)
Primary purpose treatment
(Active Comparator)
Active arm including patients who receive the study drug (500µg Roflumilast once daily)
roflumilast Daxas
Roflumilast coated tablet, 500µg oral application, once daily in the morning
(Placebo Comparator)
Control arm including patients who receive the placebo tablet (once daily)
placebo n.a.
Placebo coated tablet (visually identical to 500µg Roflumilast tablet), oral application, once daily in the morning

Primary Outcomes

Change from baseline in carotid femoral-Pulse Wave Velocity at month 6
time frame: baseline, month 6

Secondary Outcomes

Change from baseline in Reactive Hyperemia Index at month 6
time frame: baseline, month 6
Change from baseline in Augmentation Index at month 6
time frame: baseline, month 6

Eligibility Criteria

Male or female participants from 40 years up to 80 years old.

Inclusion Criteria: - Over 40 years of age - Smoking history of at least 10 pack years - Chronic obstructive pulmonary disease at GOLD-stage II - IV diagnosed according to standard criteria (18) - History of at least one COPD exacerbation requiring systemic corticosteroid treatment or hospitalisation in the previous year Exclusion Criteria: - Insufficient compliance to study medication (≤70% of tablets used) during 4 weeks run-in period - History of acute exacerbation 4 weeks prior to run-in period - Diagnosis of alpha-1-antitrypsin deficiency - Diagnosis of asthma - Acute respiratory infections (e.g. pneumonia) - Severe acute infectious diseases (e.g. active hepatitis, HIV) - Lung cancer - Bronchiectasis - Interstitial lung disease - Any other relevant lung disease - Acute myocardial infarction - Systolic left ventricular dysfunction - Congestive heart failure New York Heart Association Functional Classification (NYHA) severity grade IV - Haemodynamically significant cardiac arrhythmias or heart valve deformations - Peripheral arterial occlusive disease - Acute or chronic renal/hepatic failure - Active malignancy - Autoimmune disease - Pregnant or breastfeeding women - Women no using or not willing to use adequate contraceptive measures for the duration of the trial - Hypersensitivity to study medication or placebo - Severe psychiatric or neurological disorders or history of depression associated with suicidal ideation or behaviour - Galactose intolerance, lactase insufficiency or glucose-galactose malabsorption

Additional Information

Official title Effects of ROFLUMILAST on Markers of Subclinical Atherosclerosis In Stable COPD; the ELASTIC-trial
Principal investigator Otto C Burghuber, M.D.
Trial information was received from ClinicalTrials.gov and was last updated in September 2015.
Information provided to ClinicalTrials.gov by LudwLudwig Boltzmann Institute for COPD and Respiratory Epidemiology.