A Study to Evaluate Biomarkers in Chronic Obstructive Pulmonary Disease

Inclusion Criteria

• - Age ≥ 40 years at the time of screening
• - Written informed consent and any locally required authorization (eg, HIPAA in the USA, EU Data Privacy Directive in the EU) obtained from the subject prior to performing any protocol-related procedures, including screening evaluations.
• - Cohort 1 only: A primary diagnosis of clinically stable physician-diagnosed COPD upon entry into the study meeting one of the following criteria:
• - Subjects who have experienced a severe AECOPD requiring inpatient hospitalization in the previous 12 months
• - Subject who had one severe AECOPD requiring ED visits in the past 9 months
• - Subjects who are currently on LTOT.
• - Cohort 1 only: Stable COPD for 4 weeks prior to screening, as defined by no change in ICS therapy and no use of oral corticosteroids or antibiotics for a respiratory tract infection.
• - Cohort 1 only: Forced expiratory volume in one second (FEV1)/forced vital capacity (FVC) < 0.70 or lower limits of normal (LLN).
• - Cohort 1 only: FEV1 < 60% predicted normal value.
• - Cohort 2 only: A primary diagnosis of physician-diagnosed AECOPD requiring admission to the hospital.
• - Current smoker or ex-smoker with a tobacco history of ≥ 10 pack-years (one pack year = 20 cigarettes smoked per day for 1 year).
• - Ability and willingness to complete the appropriate follow-up period of time as required by the protocol.
• - Able to read and write and use the electronic devices (English or Spanish version).