Clareo Health | Efficacy and Safety of Oral Roflumilast Taken Once Daily in Patients Older Than 40 Years With Chronic Obstructive Pulmonary Disease (BY217/M2-119)
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
AstraZeneca
Age
40–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Written informed consent
Patients with a history of chronic obstructive pulmonary disease (COPD) as defined by the GOLD criteria (2003)
FEV1/FVC ratio (post bronchodilator) smaller or equal 70%
FEV1 (post bronchodilator) 30-80% of predicted
Fixed airway obstruction
Current smoker or former smoker (smoking cessation at least one year ago) with a smoking history of at least 10 pack years
Clinically stable COPD within 4 weeks prior to baseline visit
Availability of a chest x-ray
You may not be if
COPD exacerbation indicated by a treatment with systemic glucocorticosteroids
Lower respiratory tract infection
Diagnosis of asthma
Known alpha-1-antitrypsin deficiency
Need for long term oxygen therapy defined as longer or equal 16 hours/day
Clinically relevant abnormal laboratory values suggesting an unknown disease and requiring further clinical evaluation (as assessed by the investigator)
Known infection with HIV, active hepatitis and/or liver insufficiency (according to the Child Pugh score A or worse)
Pregnancy, breast feeding, oocyte donation or oocyte implantation planned during the trial
Female patients of childbearing potential, not using reliable method of contraception for the entire study duration, post-menopausal \> 1 year or who are not using any other method considered sufficiently reliable by the investigator in individual cases
Participation in another study (use of investigational product) within 30 days preceding the baseline visit or re-entry of patients already enroled in this trial
Alcohol or drug abuse
Inability to follow the study procedures due to e.g., language problems, physiological disorders
Use of not allowed drugs
Suspected hypersensitivity to the study medication or rescue medication
