An observational study in Pulmonary Disease, Chronic Obstructive, sponsored by GlaxoSmithKline. Completed at 13 sites in Japan. Open to participants aged 40 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-02-22.
Sponsored by GlaxoSmithKline · Observational
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
3,303 studies on the registry are indexed under Lung Diseases; 355 are open to participants now.
This study's enrollment of 70 is below the median of 157 across 929 observational studies indexed under Lung Diseases.
Browse Lung Diseases studies →GlaxoSmithKline is the lead sponsor of 3,562 studies on the registry; 117 are open to participants now.
Of its 258 completed or terminated interventional studies of FDA-regulated products, 232 (90%) have results posted.
Counted across the registry records on this site, refreshed daily.
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).
Exclusion Criteria:
Participants with COPD or Asthma-COPD overlap syndrome (ACOS)
Other: Prospective observational cohort study
Prospective observational cohort study
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)
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
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.
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
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).
Time frame: 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).
Time frame: 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.
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
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.
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
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.
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
Plan to share: No
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