A Study to Evaluate Biomarkers in Chronic Obstructive Pulmonary Disease
A Study to Evaluate Biomarkers in Chronic Obstructive Pulmonary Disease
The primary objective of this study is to identify biomarkers that can be used for evaluation
 of efficacy in subjects presenting with AECOPD
Identify biomarkers that can be used for evaluation of efficacy in subjects presenting with
 AECOPD by evaluating longitudinal changes and the interrelationship of blood and sputum
 biomarkers with physiological endpoints and symptom measures in stable subjects with COPD
 likely to experience a future AECOPD, and in subjects during severe AECOPD.
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).

 Exclusion Criteria:

 -  Participation (defined as administration of at least one dose of investigational
 product) in another clinical study, the last follow-up visit of which is within 12
 weeks (for a small molecule drug) and (6 months for a large molecule drug) of entry
 into this study.

 -  Any condition that, in the opinion of the investigator would interfere with
 interpretation of subject safety or study results.

 -  Employees of the clinical study site or any other individuals involved with the
 conduct of the study, or immediate family members of such individuals.

 -  The presence of another chronic pulmonary or systemic disease, which in the opinion of
 the investigator or medical monitor might affect the analysis of the data (eg,
 idiopathic pulmonary fibrosis, sarcoidosis, active cancer or autoimmune disease).

 -  History of immunodeficiency.

 -  Current alcohol or drug abuse or a history of unsuccessfully treated alcohol or drug
 abuse within the past year.

 -  Cohort 2 only: Diagnosis of an acute disease/condition (eg, congestive heart failure,
 acute myocardial infarction, pneumonia, or pulmonary embolus) that is the primary
 reason for the subject's hospitalization.