Etiology of Acute Exacerbations of Chronic Obstructive Pulmonary Disease (AECOPD) in Japan (NCT03957577) | Clinical Trial Compass
CompletedNot Applicable
Etiology of Acute Exacerbations of Chronic Obstructive Pulmonary Disease (AECOPD) in Japan
Japan70 participantsStarted 2019-06-13
Plain-language summary
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
Who can participate
Age range40 Years – 80 Years
SexALL
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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 …
What they're measuring
1
Number of participants with first evaluable moderate or severe AECOPD that have infectious or non-infectious etiology
Timeframe: Up to Month 12
2
Microbiome composition of sputum in stable-state COPD as measured by bacterial ribosomal ribonucleic acid (rRNA) sequencing