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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

70 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-06-13

Study Completion Date

2022-06-30

Brief Summary

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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

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Detailed Description

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Conditions

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Pulmonary Disease, Chronic Obstructive

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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All participants

Participants with COPD or Asthma-COPD overlap syndrome (ACOS)

Prospective observational cohort study

Intervention Type OTHER

Prospective observational cohort study

Interventions

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Prospective observational cohort study

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No