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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03957577
Other study ID # 208636
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 13, 2019
Est. completion date June 30, 2022

Study information

Verified date February 2024
Source GlaxoSmithKline
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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


Recruitment information / eligibility

Status Completed
Enrollment 70
Est. completion date June 30, 2022
Est. primary completion date June 30, 2022
Accepts healthy volunteers No
Gender All
Age group 40 Years to 80 Years
Eligibility 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 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.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Prospective observational cohort study
Prospective observational cohort study

Locations

Country Name City State
Japan GSK Investigational Site Fukuoka
Japan GSK Investigational Site Fukuoka
Japan GSK Investigational Site Fukuoka
Japan GSK Investigational Site Fukushima
Japan GSK Investigational Site Hiroshima
Japan GSK Investigational Site Mie
Japan GSK Investigational Site Nagasaki
Japan GSK Investigational Site Niigata
Japan GSK Investigational Site Osaka
Japan GSK Investigational Site Osaka
Japan GSK Investigational Site Osaka
Japan GSK Investigational Site Shizuoka
Japan GSK Investigational Site Tokyo

Sponsors (1)

Lead Sponsor Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

Japan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of participants with first evaluable moderate or severe AECOPD that have infectious or non-infectious etiology Up to Month 12
Primary Microbiome composition of sputum in stable-state COPD as measured by bacterial ribosomal ribonucleic acid (rRNA) sequencing Baseline (Screening visit or Month 0)
Secondary Number of all-cause moderate and severe AECOPD per participants Up to Month 12
Secondary Microbiome composition of sputum in stable-state COPD as measured by bacterial rRNA sequencing Baseline (Screening visit or Month 0)
Secondary Microbiome composition of sputum during participant's first evaluable moderate or severe AECOPD Up to Month 12
Secondary 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)
Secondary 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)
Secondary 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
Secondary Number of AECOPD events Up to Month 12
Secondary Severity of AECOPD according to healthcare utilization Up to Month 12
Secondary Severity of EXACT events according to EXACT total score Up to Month 12
Secondary Duration of AECOPD Up to Month 12
Secondary Duration of EXACT events Up to Month 12
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary Mean rate of AECOPD related healthcare resource utilization per participant Up to Month 12
Secondary Mean rate of non-AECOPD related healthcare resource utilization per participant Up to Month 12
Secondary Annual rate of AECOPD related healthcare resource utilization per participant Up to Month 12
Secondary Annual rate of non-AECOPD related healthcare resource utilization per participant Up to Month 12
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