Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Hoffmann-La Roche
Age
40–80
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Documented COPD diagnosis for ≥ 12 months
History of frequent exacerbations, defined as having had 2 or more moderate or severe COPD exacerbations within 12 months prior to screening
Post-bronchodilator FEV1 ≥ 20% and \< 80% of predicted at screening
Post-bronchodilator FEV1/FVC \< 0.70 at screening
Modified Medical Research Council (dyspnea scale) (mMRC) score ≥ 2
Current tobacco smoker or former smoker with a history of smoking ≥ 10 pack-years
On optimized COPD maintenance therapy as defined below for ≥ 12 months prior to screening, and stable on current therapy for at least 4 weeks prior to screening: Inhaled corticosteroid (ICS) plus long-acting beta-agonist (LABA), Long-acting muscarinic antagonist (LAMA) plus LABA, ICS plus LAMA plus LABA
Chest X-ray or computed tomography (CT) scan within 6 months prior to screening or chest X-ray during the screening period that confirms the absence of clinically significant lung disease besides COPD
You may not be if
Current documented diagnosis of asthma
History of clinically significant pulmonary disease other than COPD
Diagnosis of 1-antitrypsin deficiency
History of long-term treatment with oxygen at \> 4.0 liters/minute
Lung volume reduction surgery or procedure within 12 months prior to screening
Individuals participating in, or scheduled for, an intensive COPD rehabilitation program (participants who are in the maintenance phase of a rehabilitation program are eligible)
History of lung transplant
Any infection that resulted in hospital admission for ≥ 24 hours and/or treatment with oral, IV, or IM antibiotics within 4 weeks prior to or during screening
Upper or lower respiratory tract infection within 4 weeks prior to or during screening
Treatment with oral, IV, or IM corticosteroids within 4 weeks prior to initiation of study drug
Initiation of or change in non-biologic immunomodulatory or immunosuppressive therapy within 3 months prior to screening
Unstable cardiac disease, myocardial infarction, or New York Heart Association Class III or IV heart failure within 12 months prior to screening
