Condition or disease | Intervention/treatment |
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Pulmonary Disease, Chronic Obstructive | Other: Modified American Thoracic Society and National Heart and Lung Institute-Division of Lung Disease Respiratory (Mod. ATS-DLD-078) Other: Modified Medical Research Council (mMRC) Dyspnea Scale Other: Exacerbations of Chronic Pulmonary Disease Tool (EXACT) Other: COPD Assessment Test (CAT) Other: Evaluating Respiratory Symptoms in COPD (E-RS: COPD) Other: Telephonic interviews Other: Electronic Diary (eDiary) Diagnostic Test: Chest X-ray Diagnostic Test: Spirometry Other: Sputum Sampling Other: Blood sampling |
Study Type : | Observational |
Estimated Enrollment : | 110 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | A Prospective, Epidemiological, Cohort Study to Assess the Aetiology of Acute Exacerbations of Chronic Obstructive Pulmonary Disease in Japan |
Actual Study Start Date : | June 13, 2019 |
Estimated Primary Completion Date : | June 30, 2022 |
Estimated Study Completion Date : | June 30, 2022 |
Group/Cohort | Intervention/treatment |
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All subjects
Subjects will not receive any study drug as intervention in this study. Subjects will continue to use medications prescribed by their regular treating physician and will continue to visit their regular treating physician for their healthcare during the study.
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Other: Modified American Thoracic Society and National Heart and Lung Institute-Division of Lung Disease Respiratory (Mod. ATS-DLD-078)
The medical, family, smoking and occupational history of subjects will be assessed using Mod. ATS-DLD-078 questionnaire. It will be used to collect the subject's history of selected respiratory symptoms and respiratory events as well as key comorbidities.
Other: Modified Medical Research Council (mMRC) Dyspnea Scale The severity of dyspnea attributable to respiratory diseases including COPD will be assessed using a 5-point mMRC dyspnea scale ranging from 0 (breathless only with strenuous exercise) to 4 (too breathless to leave the house).
Other: Exacerbations of Chronic Pulmonary Disease Tool (EXACT) EXACT is a validated, self-administered, 14-item daily diary that assesses 11 respiratory symptoms and 3 additional symptoms, which together characterize COPD exacerbations. This will be completed by subjects daily using their electronic diary (eDiary). The EXACT total score will range from 0 to 100, with higher scores indicating a more severe condition.
Other: COPD Assessment Test (CAT) The CAT is a validated measure of health status in COPD. It is an 8-item, subject-completed instrument that covers symptoms such as cough, phlegm, chest tightness and breathlessness, and disease impacts including physical activity, confidence, sleep and energy. Subjects 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).
Other: Evaluating Respiratory Symptoms in COPD (E-RS: COPD) 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.
Other: Telephonic interviews During the telephonic interviews, the potential AECOPD will be confirmed according to the AECOPD criteria, and if confirmed, the severity will be assessed according to healthcare utilization as mild, moderate or severe.
Other: Electronic Diary (eDiary) Subjects will be asked to complete their eDiary every evening before bedtime. The eDiary consists of a total of 20 questions, which include screening questions for the detection of AECOPD during the study and the EXACT.
Diagnostic Test: Chest X-ray A chest x-ray will be used at Screening visit to assess the subject's eligibility to participate in the study. A local radiologist will review the x-ray and notify the investigator of any abnormalities not considered to be caused by COPD.
Diagnostic Test: Spirometry Spirometry measurements will be obtained using spirometry equipment. At least 3 acceptable spirometry efforts (with no more than 8 attempts) will be obtained.
Other: Sputum Sampling Sputum samples will be collected from the subjects and will be analyzed for the presence and quantity of specific cell types and biomarkers to investigate the etiology of the AECOPD.
Other: Blood sampling Blood samples will be collected from the subjects during the study and will be analyzed for the concentration of biomarkers to investigate the etiology of the AECOPD.
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Ages Eligible for Study: | 40 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
Exclusion Criteria:
Contact: US GSK Clinical Trials Call Center | 877-379-3718 | GSKClinicalSupportHD@gsk.com | |
Contact: EU GSK Clinical Trials Call Center | +44 (0) 20 89904466 | GSKClinicalSupportHD@gsk.com |
Japan | |
GSK Investigational Site | Recruiting |
Ehime, Japan, 791-0281 | |
Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
Contact: EU GSK Clinical Trials Call Centre +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
Principal Investigator: Ryoji Ito | |
GSK Investigational Site | Recruiting |
Fukuoka, Japan, 807-8555 | |
Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
Contact: EU GSK Clinical Trials Call Centre +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
Principal Investigator: Kazuhiro Yatera | |
GSK Investigational Site | Recruiting |
Fukuoka, Japan, 811-1394 | |
Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
Contact: EU GSK Clinical Trials Call Centre +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
Principal Investigator: Makoto Yoshida | |
GSK Investigational Site | Recruiting |
Fukuoka, Japan, 820-8505 | |
Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
Contact: EU GSK Clinical Trials Call Centre +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
Principal Investigator: Kazunori Tobino | |
GSK Investigational Site | Recruiting |
Mie, Japan, 515-8544 | |
Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
Contact: EU GSK Clinical Trials Call Centre +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
Principal Investigator: Osamu Hataji | |
GSK Investigational Site | Recruiting |
Nagasaki, Japan, 859-0497 | |
Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
Contact: EU GSK Clinical Trials Call Centre +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
Principal Investigator: Kiyoyasu Fukushima | |
GSK Investigational Site | Recruiting |
Niigata, Japan, 940-2085 | |
Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
Contact: EU GSK Clinical Trials Call Centre +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
Principal Investigator: Kazuhiro Sato | |
GSK Investigational Site | Recruiting |
Osaka, Japan, 560-8552 | |
Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
Contact: EU GSK Clinical Trials Call Centre +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
Principal Investigator: Keisuke Miki | |
GSK Investigational Site | Recruiting |
Osaka, Japan, 591-8555 | |
Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
Contact: EU GSK Clinical Trials Call Centre +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
Principal Investigator: Yoshikazu Inoue | |
GSK Investigational Site | Completed |
Osaka, Japan, 596-8501 | |
GSK Investigational Site | Recruiting |
Shizuoka, Japan, 438-8550 | |
Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
Contact: EU GSK Clinical Trials Call Centre +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
Principal Investigator: Shiro Imokawa | |
GSK Investigational Site | Recruiting |
Tokyo, Japan, 142-8666 | |
Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
Contact: EU GSK Clinical Trials Call Centre +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
Principal Investigator: Tetsuya Homma |
Study Director: | GSK Clinical Trials | GlaxoSmithKline |
Tracking Information | |||||||||
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First Submitted Date | May 17, 2019 | ||||||||
First Posted Date | May 21, 2019 | ||||||||
Last Update Posted Date | November 18, 2020 | ||||||||
Actual Study Start Date | June 13, 2019 | ||||||||
Estimated Primary Completion Date | June 30, 2022 (Final data collection date for primary outcome measure) | ||||||||
Current Primary Outcome Measures |
Number of subjects with first evaluable moderate or severe AECOPD that have infectious or non-infectious etiology [ Time Frame: Up to Month 12 ] Number of subjects with first evaluable moderate or severe AECOPD that have infectious or non-infectious etiology will be assessed at given time point.
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Original Primary Outcome Measures | Same as current | ||||||||
Change History | |||||||||
Current Secondary Outcome Measures |
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Original Secondary Outcome Measures | Same as current | ||||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
Descriptive Information | |||||||||
Brief Title | Etiology of Acute Exacerbations of Chronic Obstructive Pulmonary Disease (AECOPD) in Japan | ||||||||
Official Title | A Prospective, Epidemiological, Cohort Study to Assess the Aetiology of Acute Exacerbations of Chronic Obstructive Pulmonary Disease in Japan | ||||||||
Brief Summary | Chronic obstructive pulmonary disease (COPD) is a common, preventable and treatable disease characterized by increasing airflow obstruction and the progressive development of respiratory symptoms including chronic cough, increased sputum production, dyspnea, and wheezing. The purpose of this prospective, epidemiological, cohort study is to evaluate the etiology of AECOPD in a Japanese population for comparison with observations in studies conducted in the United States of America and Europe. This study will support a precision medicine approach to COPD by estimating the proportion of bacterial, viral, eosinophilic and pauci-inflammatory exacerbations experienced by subjects and by comparing the lung microbiome, including the presence of potentially pathogenic viruses and bacteria, in stable-state COPD and during an AECOPD. | ||||||||
Detailed Description | Not Provided | ||||||||
Study Type | Observational | ||||||||
Study Design | Observational Model: Cohort Time Perspective: Prospective |
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Target Follow-Up Duration | Not Provided | ||||||||
Biospecimen | Not Provided | ||||||||
Sampling Method | Non-Probability Sample | ||||||||
Study Population | This study will enroll subjects with a recorded clinical diagnosis of COPD, Asthma-COPD overlap syndrome (ACOS) or Chronic bronchitis (CB), who have airflow limitation indicative of COPD according to Global Initiative for Chronic Obstructive Lung Disease (GOLD) and a recent history of lower respiratory tract infection (LRTI). | ||||||||
Condition | Pulmonary Disease, Chronic Obstructive | ||||||||
Intervention |
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Study Groups/Cohorts | All subjects
Subjects will not receive any study drug as intervention in this study. Subjects will continue to use medications prescribed by their regular treating physician and will continue to visit their regular treating physician for their healthcare during the study.
Interventions:
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Publications * | Not Provided | ||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status | Recruiting | ||||||||
Estimated Enrollment |
110 | ||||||||
Original Estimated Enrollment | Same as current | ||||||||
Estimated Study Completion Date | June 30, 2022 | ||||||||
Estimated Primary Completion Date | June 30, 2022 (Final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 40 Years and older (Adult, Older Adult) | ||||||||
Accepts Healthy Volunteers | No | ||||||||
Contacts |
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Listed Location Countries | Japan | ||||||||
Removed Location Countries | |||||||||
Administrative Information | |||||||||
NCT Number | NCT03957577 | ||||||||
Other Study ID Numbers | 208636 | ||||||||
Has Data Monitoring Committee | No | ||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement | Not Provided | ||||||||
Responsible Party | GlaxoSmithKline | ||||||||
Study Sponsor | GlaxoSmithKline | ||||||||
Collaborators | Not Provided | ||||||||
Investigators |
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PRS Account | GlaxoSmithKline | ||||||||
Verification Date | November 2020 |