Etiology of Acute Exacerbations of Chronic Obstructive Pulmonary Disease (AECOPD) in Japan

  • End date
    Jun 30, 2022
  • participants needed
  • sponsor
Updated on 5 August 2021
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respiratory symptom


The purpose of this prospective, epidemiological, cohort study is to evaluate the lung microbiome in stable-state chronic obstructive pulmonary disease (COPD) in Japanese participants

Condition Chronic Obstructive Lung Disease, COPD (Chronic Obstructive Pulmonary Disease)
Treatment spirometry, blood sampling, Chest X-ray, Telephonic interviews, Modified American Thoracic Society and National Heart and Lung Institute-Division of Lung Disease Respiratory (Mod. ATS-DLD-078), Modified Medical Research Council (mMRC) Dyspnea Scale, Exacerbations of Chronic Pulmonary Disease Tool (EXACT), COPD Assessment Test (CAT), Evaluating Respiratory Symptoms in COPD (E-RS: COPD), Electronic Diary (eDiary), Sputum Sampling, Prospective observational cohort study
Clinical Study IdentifierNCT03957577
Last Modified on5 August 2021


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Inclusion Criteria

Participants must be able and willing to comply with the requirements of the protocol
Participant must be aged greater than or equal to (>=)40 years to to less than or equal to (<=)80 years at the time of signing the informed consent form (ICF)
Participants must have a record of a clinical diagnosis of COPD, ACOS or CB
Participants must have moderate to severe airflow limitation based on spirometry: FEV1 percent predicted normal >=30 to <=80 percent (%) and post-bronchodilator FEV1/forced vital capacity (FVC) ratio <0.7
Participants must be symptomatic at Screening, defined as having a CAT score >=10
Participants must have a documented history of at least 1 LRTI treated with antibiotics and/or oral/systemic corticosteroids
Participants must be current or former tobacco (cigarette) smokers with a smoking history of >=10 pack-years
Participants may be male or female. For female participants: A female participant is eligible to participate if she is not pregnant or breastfeeding. Women of non-childbearing potential can also participate. A woman of childbearing potential must have had a highly sensitive negative urine pregnancy test
Participants should be able to provide a spontaneous or induced sputum sample of >=0.2 grams (g) at the Screening Visit

Exclusion Criteria

Participants with a diagnosed respiratory disorder other than COPD, ACOS or CB
Participants with a diagnosis of alpha-1 antitrypsin deficiency as the underlying cause of COPD
Participants who have received antibiotics within 1 month of Screening or have received antibiotics for more than 30 days within 90 days prior to Screening; Except for those who have received and are currently receiving long-term treatment with low-dose macrolide: erythromycin <=600 milligrams (mg) per (/) day or clarithromycin <=200 mg/day
Participants who have received systemic corticosteroids (oral/intravenous/intramuscular) for more than 14 consecutive days within 90 days prior to giving informed consent
Participants who are unable to use or to comply with daily completion of the eDiary
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