Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
LudwLudwig Boltzmann Institute for COPD and Respiratory Epidemiology
With
Medical University of Vienna
Age
40–80
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
Clareo Health | Effects of ROFLUMILAST on Subclinical Atherosclerosis in Chronic Obstructive Pulmonary Disease (COPD)
