Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| All participants | Participants with COPD or Asthma-COPD overlap syndrome (ACOS) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prospective observational cohort study | Other | Prospective observational cohort study |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with first evaluable moderate or severe AECOPD that have infectious or non-infectious etiology | Up to Month 12 | |
| Microbiome composition of sputum in stable-state COPD as measured by bacterial ribosomal ribonucleic acid (rRNA) sequencing | Baseline (Screening visit or Month 0) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of all-cause moderate and severe AECOPD per participants | Up to Month 12 | |
| Microbiome composition of sputum in stable-state COPD as measured by bacterial rRNA sequencing | Baseline (Screening visit or Month 0) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
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).
Not provided
| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Fukuoka | 807-8555 | Japan | |||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40391128 | Derived | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| D000080445 | Asthma-Chronic Obstructive Pulmonary Disease Overlap Syndrome |
| D029481 | Bronchitis, Chronic |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
Not provided
Not provided
Not provided
Not provided
Not provided
| Microbiome composition of sputum during participant's first evaluable moderate or severe AECOPD | 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) | 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 | 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. | Up to Month 12 |
| Number of AECOPD events | Up to Month 12 |
| Severity of AECOPD according to healthcare utilization | Up to Month 12 |
| Severity of EXACT events according to EXACT total score | Up to Month 12 |
| Duration of AECOPD | Up to Month 12 |
| Duration of EXACT events | 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). | 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). | 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. | 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. | 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. | 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 | Baseline (Screening visit or Month 0) and up to month 12 |
| Mean rate of AECOPD related healthcare resource utilization per participant | Up to Month 12 |
| Mean rate of non-AECOPD related healthcare resource utilization per participant | Up to Month 12 |
| Annual rate of AECOPD related healthcare resource utilization per participant | Up to Month 12 |
| Annual rate of non-AECOPD related healthcare resource utilization per participant | Up to Month 12 |
| Fukuoka |
| 811-1394 |
| Japan |
| GSK Investigational Site | Fukuoka | 820-8505 | Japan |
| GSK Investigational Site | Fukushima | 960-1295 | Japan |
| GSK Investigational Site | Hiroshima | 734-8530 | Japan |
| GSK Investigational Site | Mie | 515-8544 | Japan |
| GSK Investigational Site | Nagasaki | 859-0497 | Japan |
| GSK Investigational Site | Niigata | 940-2085 | Japan |
| GSK Investigational Site | Osaka | 560-8552 | Japan |
| GSK Investigational Site | Osaka | 591-8555 | Japan |
| GSK Investigational Site | Osaka | 596-8501 | Japan |
| GSK Investigational Site | Shizuoka | 438-8550 | Japan |
| GSK Investigational Site | Tokyo | 142-8666 | Japan |
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001249 | Asthma |
| D001982 | Bronchial Diseases |
| D012130 | Respiratory Hypersensitivity |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D001991 | Bronchitis |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |