Effects of the anti-inflammatory drug ROFLUMILAST on markers of early atherosclerosis in chronoc bostructive pulmonary disease

Phase 1

• Conditions: chronic obstructive pulmonary disease; MedDRA version: 14.1Level: LLTClassification code 10010952Term: COPDSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2011-004152-19-AT
• Lead Sponsor: udwig Boltzmann institute for COPD and Respiratory Epidemiology

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-02-17
• Last Update Posted: 30 May 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

Over 40 years of age
Smoking history of at least 10 pack years
Chronic obstructive pulmonary disease at GOLD-stage II - IV
History of at least one COPD exacerbation requiring systemic corticosteroid treatment or hospitalisation in the previous year

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 80
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 80

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-antitrypsine 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 NYHA (New York Heart Association Functional Classification) 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To investigate the effects of ROFLUMILAST 500µg once daily on arterial stiffness in patients with COPD;Secondary Objective: To investigate the effects of ROFLUMILAST 500µg once daily on endothelial dysfunction in patients with COPD;Primary end point(s): Between groups difference after 24 weeks in the change ofcarotid femoral-Pulse Wave Velocity ;Timepoint(s) of evaluation of this end point: 24 weeks ofter start of study drug administration

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): between groups difference after 24 weeks in the change of:<br>-Augmentation Index <br>-Reactive Hyperemia Index<br>-C-reactive Protein <br>-Matrix Metalloproteinase-9 <br>-Asymmetric dimethylarginine <br>- soluble Receptor for Advanced Glycation Endproducts<br>-Brachial artery Intima-Media Thickness <br>-Forced Expiratory Volume in one sekond<br>-6 Minute Walk Test <br>-St. George Respiratory Questionaire<br>-COPD assessment test (CAT score)<br>;Timepoint(s) of evaluation of this end point: 24 weeks ofter start of study drug administration