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
1\. Male or female patients at least 40 years of age
2\. History of COPD (according to Global Initiative for Chronic Obstructive Lung Disease \[GOLD\] 2010) for at least 12 months prior to Screening (Visit 1) associated with chronic productive cough for 3 months in each of 2 consecutive years (with other causes of productive cough excluded). Only patients with chronic bronchitis will be included (concomitant emphysema is permitted)
3\. Forced expiratory volume after 1 second (FEV1)/forced vital capacity (FVC) ratio (postbronchodilator) \< 70% at Screening (Visit 1)
4\. FEV1 (postbronchodilator) ≤ 50% of predicted at Screening (Visit 1)
5\. At least two documented moderate or severe COPD exacerbations within 12 months prior to Screening (Visit 1)
6\. Patients must be on FDC LABA/ICS treatment ≥ 3 months prior to Screening (Visit 1)
7\. Former smokers (defined as smoking cessation at least 1 year ago) or current smokers (including patients who ceased smoking within the past year) both with a smoking history of at least 20 pack-years
You may not be if
1\. Moderate or severe COPD exacerbation and/or COPD exacerbations treated with antibiotics or systemic glucocorticosteroids within 4 weeks of Screening (Visit 1) (ie, patients must be clinically stable)
2\. Known alpha-1-antitrypsin deficiency
3\. Current diagnosis of asthma (either controlled or uncontrolled) (Note: History of childhood asthma is not exclusionary.)
4\. Body mass index (BMI) ≥ 45 kg/m2
5\. Patients with a history (within 5 years) or current diagnosis of cancer other than basal or squamous cell skin cancer
Clareo Health | Roflumilast in Chronic Obstructive Pulmonary Disease (COPD) Patients Treated With Fixed Dose Combinations of Long-acting β2-agonist (LABA) and Inhaled Corticosteroid (ICS)
