chronic obstructive pulmonary disease MedDRA version: 14.1 Level: LLT Classification code 10010952 Term: COPD System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Conditions
Interventions
Trade Name: DAXAS
Pharmaceutical Form: Coated tablet
INN or Proposed INN: roflumilast
CAS Number: 162401-32-3
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 500-
P
Sponsors
Ludwig Boltzmann institute for COPD and Respiratory Epidemiology
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 of carotid femoral-Pulse Wave Velocity ;Timepoint(s) of evaluation of this end point: 24 weeks ofter start of study drug administration | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): between groups difference after 24 weeks in the change of: - Augmentation Index - Reactive Hyperemia Index - C-reactive Protein - Matrix Metalloproteinase-9 - Asymmetric dimethylarginine - soluble Receptor for Advanced Glycation Endproducts - Brachial artery Intima-Media Thickness - Forced Expiratory Volume in one sekond - 6 Minute Walk Test - St. George Respiratory Questionaire - COPD assessment test (CAT score) ;Timepoint(s) of evaluation of this end point: 24 weeks ofter start of study drug administration | — |
Countries
Austria
Contacts
Public ContactLudwig Boltzmann institute for COPD
Ludwig Boltzmann institute for COPD and Respiratory Epidemiology
Outcome results
None listed