Pulmonary Disease, Chronic ObstructiveNCT03957577

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

An observational study of Pulmonary Disease, Chronic Obstructive, run by GlaxoSmithKline at 13 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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 Read more about this study

Who is it for?: Ages 40 to 80 years
Conditions the study is for: Pulmonary Disease, Chronic Obstructive
What is being tested?: Prospective observational cohort study
How many people: 70 participants
Where: 13 sitesJapan
Study dates: 13 Jun 2019to 30 Jun 2022
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 40 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Study population: This study will enroll participants with a recorded clinical diagnosis of COPD, ACOS or chronic bronchitis (CB), who have airflow limitation indicative of COPD according to Global Initiative for Chronic Obstructive Lung Disease and a recent history of lower respiratory tract infection (LRTI).

Who may be able to join

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.

Show all 9Show fewer

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.

Who cannot join

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.

Trial locations and contacts

13 sites in 1 country.

City, postcode or hospital

13 sites in 1 country

Japan13 sites

GSK Investigational Site
Fukuoka, 807-8555
GSK Investigational Site
Fukuoka, 811-1394
GSK Investigational Site
Fukuoka, 820-8505
GSK Investigational Site
Fukushima, 960-1295
GSK Investigational Site
Hiroshima, 734-8530
GSK Investigational Site
Mie, 515-8544
GSK Investigational Site
Nagasaki, 859-0497
GSK Investigational Site
Niigata, 940-2085
GSK Investigational Site
Osaka, 560-8552
GSK Investigational Site
Osaka, 591-8555
GSK Investigational Site
Osaka, 596-8501
GSK Investigational Site
Shizuoka, 438-8550
GSK Investigational Site
Tokyo, 142-8666

Other trials in Japan

About this study

Official title: A Prospective, Epidemiological, Cohort Study to Assess the Aetiology of Acute Exacerbations of Chronic Obstructive Pulmonary Disease in Japan

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

Conditions: Pulmonary Disease, Chronic Obstructive
Being tested: Prospective observational cohort study
Keywords: Asthma-COPD overlap syndrome, Acute exacerbations of chronic obstructive pulmonary disease, Acute Exacerbation and Respiratory Infections in COPD-Japan, Chronic bronchitis, Chronic obstructive pulmonary disease, Exacerbation, Microbiome, Quantitative polymerase chain reaction (qPCR), 16S ribosomal Ribonucleic acid (16S rRNA), Metagenomic analysis, Sputum
Medical subject headings: Pulmonary Disease, Chronic Obstructive, Asthma-Chronic Obstructive Pulmonary Disease Overlap Syndrome, Bronchitis, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Prospective observational cohort studyOther
Prospective observational cohort study

Study groups in NCT03957577
Study group	Role	What they receive
All participants		Participants with COPD or Asthma-COPD overlap syndrome (ACOS) Receives: Other: Prospective observational cohort study

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of participants with first evaluable moderate or severe AECOPD that have infectious or non-infectious etiology
Measured: Up to Month 12
Microbiome composition of sputum in stable-state COPD as measured by bacterial ribosomal ribonucleic acid (rRNA) sequencing
Measured: Baseline (Screening visit or Month 0)

Secondary outcomes (21)

Number of all-cause moderate and severe AECOPD per participants
Measured: Up to Month 12
Microbiome composition of sputum in stable-state COPD as measured by bacterial rRNA sequencing
Measured: Baseline (Screening visit or Month 0)
Microbiome composition of sputum during participant's first evaluable moderate or severe AECOPD
Measured: Up to Month 12
Number of participants with first evaluable sputum samples that are positive for potentially pathogenic viruses (overall and by species) and bacteria in stable state COPD as measured by bacterial culture or quantitative polymerase chain reaction (qPCR)
Measured: Baseline (Screening visit or Month 0)
Number of participants with first evaluable sputum samples that are positive for potentially pathogenic viruses (overall and by species) and bacteria during moderate or severe AECOPD as measured by bacterial culture or qPCR
Measured: Baseline (Screening visit or Month 0)
Number of EXACT events per participant over the course of 12 months
An EXACT event is defined as an increase in EXACT score more than or equal to 12 points for 2 days or more than or equal to 9 points for 3 days, above the participant's mean Baseline score. Severity is indicated by the worst (i.e., highest) EXACT total score during the course of the event.
Measured: Up to Month 12
Number of AECOPD events
Measured: Up to Month 12
Severity of AECOPD according to healthcare utilization
Measured: Up to Month 12
Severity of EXACT events according to EXACT total score
Measured: Up to Month 12
Duration of AECOPD
Measured: Up to Month 12
Duration of EXACT events
Measured: Up to Month 12
Mean change in CAT score between stable-state COPD and participants' first evaluable moderate or severe AECOPD
The CAT is a 8-item, participant-completed instrument that covers symptoms such as cough, phlegm, chest tightness and breathlessness, and disease impacts including physical activity, confidence, sleep and energy. Participants will be asked to score each item on a scale ranging from 0 (no symptom or impact at all) to 5 (maximal symptom or impact).
Measured: Baseline (Screening visit or Month 0) and up to Month 12
Mean change in CAT score over the course of 1 year
The CAT is a 8-item, participant-completed instrument that covers symptoms such as cough, phlegm, chest tightness and breathlessness, and disease impacts including physical activity, confidence, sleep and energy. Participants will be asked to score each item on a scale ranging from 0 (no symptom or impact at all) to 5 (maximal symptom or impact).
Measured: Baseline (Screening visit or Month 0) and up to Month 12
Mean change in EXACT score
EXACT is a validated, self-administered, 14-item daily diary that assesses 11 respiratory symptoms and 3 additional symptoms, which together characterize COPD exacerbations. The EXACT total score will range from 0 to 100, with higher scores indicating a more severe condition.
Measured: Baseline(Screening visit or Month 0) and up to Month 12
Mean change in E-RS COPD total and subscale scores between stable-state COPD and participants' first evaluable moderate or severe AECOPD
The E-RS: COPD comprises 11 of the 14 items of the parent EXACT that are specifically related to respiratory symptoms and will be completed using the eDiary. The RS-Total score is computed by taking the sum of the items comprising the instrument, with scores ranging from 0 to 40, with higher scores indicating more severe respiratory symptoms.
Measured: Baseline (Screening visit or Month 0) and up to Month 12
Mean change in E-RS: COPD total and subscale scores over the course of 1 year
The E-RS: COPD comprises 11 of the 14 items of the parent EXACT that are specifically related to respiratory symptoms and will be completed using the eDiary. The RS-Total score is computed by taking the sum of the items comprising the instrument, with scores ranging from 0 to 40, with higher scores indicating more severe respiratory symptoms.
Measured: Baseline (Screening visit or Month 0) and up to Month 12
Mean change in Forced expiratory volume in 1 second (FEV1) between stable-state COPD, during participants' first evaluable moderate or severe AECOPD
Measured: Baseline (Screening visit or Month 0) and up to month 12
Mean rate of AECOPD related healthcare resource utilization per participant
Measured: Up to Month 12
Mean rate of non-AECOPD related healthcare resource utilization per participant
Measured: Up to Month 12
Annual rate of AECOPD related healthcare resource utilization per participant
Measured: Up to Month 12
Annual rate of non-AECOPD related healthcare resource utilization per participant
Measured: Up to Month 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

13 Jun 201930 Jun 2022

First posted21 May 2019
Study start13 Jun 2019
Primary completion30 Jun 2022
Study completion30 Jun 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Pulmonary Disease, Chronic ObstructiveStudies of the same condition, open and under way.
More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 70 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03957577
Sponsor's protocol ID: 208636
Status last verified: Feb 2024
First submitted: 17 May 2019
Last updated: 22 Feb 2024
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Yatera K, Wang Z, Shibata Y, Ishikawa N, Homma T, Fukushima K, Hataji O, Inoue Y, Kawabata H, Miki K, Sato K, Tobino K, Yoshida M, Ishii T, Ito R, Kobayashi T, Kawamatsu S, Compton CH, Jones PW. Sputum Microbiome, Potentially Pathogenic Organisms, and Clinical Outcomes in Japanese Patients with COPD and Moderate Airflow Limitation: The Prospective AERIS-J Study. Int J Chron Obstruct Pulmon Dis. 2025 May 14;20:1477-1492. doi: 10.2147/COPD.S481406. eCollection 2025.
PubMed 40391128

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Pulmonary Disease, Chronic Obstructive trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Prospective, Epidemiological, Cohort Study to Assess the Aetiology of Acute Exacerbations of Chronic Obstructive Pulmonary Disease in Japan
ClinicalTrials.gov ID: NCT03957577
Acronym / sponsor ID: 208636
Conditions: Pulmonary Disease, Chronic Obstructive
Keywords: Asthma-COPD overlap syndrome, Acute exacerbations of chronic obstructive pulmonary disease, Acute Exacerbation and Respiratory Infections in COPD-Japan, Chronic bronchitis, Chronic obstructive pulmonary disease, Exacerbation, Microbiome, Quantitative polymerase chain reaction (qPCR)
Study type: Observational
Recruitment status: Completed
Enrolment: 70 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: 13 Jun 2019 (actual)
Primary completion: 30 Jun 2022 (actual)
Study completion: 30 Jun 2022 (actual)
First posted: 21 May 2019 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
All participants	–	Other: Prospective observational cohort studyParticipants with COPD or Asthma-COPD overlap syndrome (ACOS)

Who may qualify

Ages: 40 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: This study will enroll participants with a recorded clinical diagnosis of COPD, ACOS or chronic bronchitis (CB), who have airflow limitation indicative of COPD according to Global Initiative for Chronic Obstructive Lung Disease and a recent history of lower respiratory tract infection (LRTI).

Key inclusion criteria (9 listed)

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.

Key exclusion criteria (5 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Prospective observational cohort studyProspective observational cohort study	Other	All participants

Primary outcome

Number of participants with first evaluable moderate or severe AECOPD that have infectious or non-infectious etiology
Time frame: Up to Month 12
Microbiome composition of sputum in stable-state COPD as measured by bacterial ribosomal ribonucleic acid (rRNA) sequencing
Time frame: Baseline (Screening visit or Month 0)

21 secondary outcomes

Number of all-cause moderate and severe AECOPD per participants
Time frame: Up to Month 12
Microbiome composition of sputum in stable-state COPD as measured by bacterial rRNA sequencing
Time frame: Baseline (Screening visit or Month 0)
Microbiome composition of sputum during participant's first evaluable moderate or severe AECOPD
Time frame: Up to Month 12
Number of participants with first evaluable sputum samples that are positive for potentially pathogenic viruses (overall and by species) and bacteria in stable state COPD as measured by bacterial culture or quantitative polymerase chain reaction (qPCR)
Time frame: Baseline (Screening visit or Month 0)
Number of participants with first evaluable sputum samples that are positive for potentially pathogenic viruses (overall and by species) and bacteria during moderate or severe AECOPD as measured by bacterial culture or qPCR
Time frame: Baseline (Screening visit or Month 0)
Number of EXACT events per participant over the course of 12 months
Time frame: Up to Month 12
Number of AECOPD events
Time frame: Up to Month 12
Severity of AECOPD according to healthcare utilization
Time frame: Up to Month 12
Severity of EXACT events according to EXACT total score
Time frame: Up to Month 12
Duration of AECOPD
Time frame: Up to Month 12
Duration of EXACT events
Time frame: Up to Month 12
Mean change in CAT score between stable-state COPD and participants' first evaluable moderate or severe AECOPD
Time frame: Baseline (Screening visit or Month 0) and up to Month 12
Mean change in CAT score over the course of 1 year
Time frame: Baseline (Screening visit or Month 0) and up to Month 12
Mean change in EXACT score
Time frame: Baseline(Screening visit or Month 0) and up to Month 12
Mean change in E-RS COPD total and subscale scores between stable-state COPD and participants' first evaluable moderate or severe AECOPD
Time frame: Baseline (Screening visit or Month 0) and up to Month 12
Mean change in E-RS: COPD total and subscale scores over the course of 1 year
Time frame: Baseline (Screening visit or Month 0) and up to Month 12
Mean change in Forced expiratory volume in 1 second (FEV1) between stable-state COPD, during participants' first evaluable moderate or severe AECOPD
Time frame: Baseline (Screening visit or Month 0) and up to month 12
Mean rate of AECOPD related healthcare resource utilization per participant
Time frame: Up to Month 12
Mean rate of non-AECOPD related healthcare resource utilization per participant
Time frame: Up to Month 12
Annual rate of AECOPD related healthcare resource utilization per participant
Time frame: Up to Month 12
Annual rate of non-AECOPD related healthcare resource utilization per participant
Time frame: Up to Month 12

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2024.
Derived from this study: PubMed 40391128Yatera K, Wang Z, Shibata Y, Ishikawa N, Homma T, Fukushima K, Hataji O, Inoue Y, Kawabata H, Miki K, Sato K, Tobino K, Yoshida M, Ishii T, Ito R, Kobayashi T, Kawamatsu S, Compton CH, Jones PW. Sputum Microbiome, Potentially Pathogenic Organisms, and Clinical Outcomes in Japanese Patients with COPD and Moderate Airflow Limitation: The Prospective AERIS-J Study. Int J Chron Obstruct Pulmon Dis. 2025 May 14;20:1477-1492. doi: 10.2147/COPD.S481406. eCollection 2025.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

GSK Clinical Trials study director

GlaxoSmithKline

13 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Pulmonary Disease, Chronic Obstructive, run by GlaxoSmithKline at 13 sites in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of participants with first evaluable moderate or severe AECOPD that have infectious or non-infectious etiology (time frame: Up to Month 12). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03957577, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2024.