Etiology of Acute Exacerbations of Chronic Obstructive Pulmonary Disease (AECOPD) in Japan
Etiology of Acute Exacerbations of Chronic Obstructive Pulmonary Disease (AECOPD) in Japan
Chronic obstructive pulmonary disease (COPD) is a common, preventable and treatable disease
 characterized by increasing airflow obstruction and the progressive development of
 respiratory symptoms including chronic cough, increased sputum production, dyspnea, and
 wheezing. The purpose of this prospective, epidemiological, cohort study is to evaluate the
 etiology of AECOPD in a Japanese population for comparison with observations in studies
 conducted in the United States of America and Europe. This study will support a precision
 medicine approach to COPD by estimating the proportion of bacterial, viral, eosinophilic and
 pauci-inflammatory exacerbations experienced by subjects and by comparing the lung
 microbiome, including the presence of potentially pathogenic viruses and bacteria, in
 stable-state COPD and during an AECOPD.
Inclusion Criteria:

 -  Subjects must be able and willing to comply with the requirements of the protocol.

 -  Subject must be aged greater than or equal to 40 years at the time of signing the
 informed consent form (ICF).

 -  Subjects must have a record of a clinical diagnosis of COPD, ACOS or CB.

 -  Subjects must have moderate to severe airflow limitation based on spirometry:FEV1
 percent predicted normal greater than or equal to 40 to less than or equal to 80% and
 post-bronchodilator FEV1/forced vital capacity (FVC) ratio less than 0.7.

 -  Subjects must be symptomatic, defined as having a CAT score greater than or equal to
 10.

 -  Subjects must have a documented history of at least 1 LRTI treated with antibiotics
 and/or oral/systemic corticosteroids, which may include an exacerbation of COPD, in
 the 12 months prior to Screening, and must have not experienced either of these in the
 4 weeks prior to Screening, and must be determined to be stable-COPD by the
 investigator.

 -  Subjects must be current or former tobacco (cigarette) smokers with a smoking history
 of greater than or equal to 10 pack-years.

 -  Subjects may be male or female.

 -  For female subjects: A female subject is eligible to participate if she is not
 pregnant or breastfeeding, and at least one of the following conditions applies: Is
 not a woman of child bearing potential (WOCBP) or Is a WOCBP and using an acceptable
 contraceptive method during the study period.The investigator should evaluate the
 effectiveness of the contraceptive method. A WOCBP must have had a highly sensitive
 urine pregnancy test within 2 weeks prior to enrolment that proved negative. If a
 urine pregnancy test cannot be confirmed as negative (example given [e.g.], an
 ambiguous result), a serum pregnancy test is required. In such cases, the subject must
 be excluded from participation if the serum pregnancy result is positive. The
 investigator is responsible for review of subject's medical history, menstrual
 history, and recent sexual activity to decrease the risk of including a woman with an
 early undetected pregnancy.

 -  Subjects must be capable of giving signed informed consent.

 Exclusion Criteria:

 -  Subjects with a diagnosed respiratory disorder other than COPD, ACOS or CB (such as:
 sarcoidosis; active tuberculosis or are receiving tuberculosis treatment; clinically
 significant bronchiectasis (greater than 20% lung damage on computed tomography [CT]
 scan), lung fibrosis, pulmonary embolism, or pneumothorax; lung cancer diagnosed
 within the previous 5 years; asthma only or a current primary diagnosis of asthma in
 the opinion of the investigator); or chest imaging revealing evidence of clinically
 significant abnormalities not believed to be due to the presence of COPD.

 -  Subjects with a diagnosis of alpha-1 antitrypsin deficiency as the underlying cause of
 COPD.

 -  Subjects who have had lung surgery within 12 months prior to Screening, or plans to
 have lung surgery within 12 months after study entry.

 -  Subjects with any confirmed or suspected immunosuppressive or immunodeficient
 condition, based on medical history and physical examination (no laboratory testing
 required).

 -  Subjects who have a psychiatric disorder or any other condition that interferes with
 the ability to understand the study procedures.

 -  Subjects who have received antibiotics within 1 month of Screening or have received
 antibiotics for more than 30 days within 90 days prior to Screening.

 -  Subjects who have received systemic corticosteroids (oral/intravenous/intramuscular)
 for more than 14 consecutive days within 90 days prior to giving informed consent.

 -  Subjects who have received macrolides for more than 30 days within 90 days prior to
 Screening.

 -  Subjects who have received chemotherapy for cancer in the 12 months prior to
 Screening.

 -  Participation in the study would result in loss of blood or blood products in excess
 of 500 milliliter (mL) within 12 months.

 -  Subjects who have participated in a clinical study and been exposed to an
 investigational vaccine, pharmaceutical product or device within 30 days prior to
 Screening, or within five half-lives (t1/2) or twice the duration of the biological
 effect of the investigational product (whichever is longer).

 -  Subjects who are unable to perform spirometry due to, for example, recent eye surgery
 or thoracic or abdominal surgery, unstable cardiovascular status, recent myocardial
 infarction or pulmonary embolism or an allergy to short-acting beta2-agonsts (SABAs).

 -  Subjects who are unable to use or to comply with daily completion of the eDiary.