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

NCT ID: NCT01630200

Last Updated: 2019-04-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-05-31
• Study Completion Date: 2016-01-31

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.

Conditions

Chronic Obstructive Pulmonary Disease and Allied Conditions

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Roflumilast

Active arm including patients who receive the study drug (500µg Roflumilast once daily)

Group Type: ACTIVE_COMPARATOR

Roflumilast

Intervention Type: DRUG

Roflumilast coated tablet, 500µg oral application, once daily in the morning

Placebo

Control arm including patients who receive the placebo tablet (once daily)

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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

Interventions

Roflumilast

Roflumilast coated tablet, 500µg oral application, once daily in the morning

Intervention Type: DRUG

Placebo

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

Intervention Type: DRUG

Other Intervention Names

Daxas

Eligibility Criteria

Inclusion Criteria

• Over 40 years of age
• Smoking history of at least 10 pack years
• Chronic obstructive pulmonary disease at Global Initiative for Chronic Obstructive Lung Disease (GOLD) stage II - IV diagnosed according to standard criteria.
• 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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical University of Vienna

OTHER

Sponsor Role: collaborator

LudwLudwig Boltzmann Institute for COPD and Respiratory Epidemiology

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Otto C Burghuber, M.D.

Role: PRINCIPAL_INVESTIGATOR

Department for Respiratory and Critical Care Medicine, Otto Wagner Hospital, Vienna

Locations

Deparment for Respiratory and Critical Care Medicine, Otto Wangner Hospital

Vienna, , Austria

Countries

Austria

References

Urban MH, Kreibich N, Gleiss A, Funk GC, Hartl S, Burghuber OC. Effects of roflumilast on arterial stiffness in COPD (ELASTIC): A randomized trial. Respirology. 2021 Feb;26(2):153-160. doi: 10.1111/resp.13914. Epub 2020 Jul 28.

Reference Type: DERIVED

PMID: 32725799 (View on PubMed)

Other Identifiers

ELASTIC2011

Identifier Type: -

Identifier Source: org_study_id