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 range

40 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 …

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of participants with first evaluable moderate or severe AECOPD that have infectious or non-infectious etiology

Timeframe: Up to Month 12

Microbiome composition of sputum in stable-state COPD as measured by bacterial ribosomal ribonucleic acid (rRNA) sequencing

Timeframe: Baseline (Screening visit or Month 0)

Trial details

NCT IDNCT03957577

SponsorGlaxoSmithKline

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2022-06-30

View on ClinicalTrials.gov More Pulmonary Disease, Chronic Obstructive trials