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

NCT03957577 | Completed

• 1 other identifier: 208636
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 13

Brief 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

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); 16S ribosomal Ribonucleic acid (16S rRNA); Metagenomic analysis; Sputum

Outcome Measures

Primary Outcomes (2)

• 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)

Secondary Outcomes (21)

• 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)

• 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)

Study Arms (1)

All participants

Participants with COPD or Asthma-COPD overlap syndrome (ACOS)

Other: Prospective observational cohort study

Interventions

Prospective observational cohort study OTHER

Prospective observational cohort study

All participants

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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).

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (13)

GSK Investigational Site

Fukuoka, 807-8555, Japan

Location

GSK Investigational Site

Fukuoka, 811-1394, Japan

Location

GSK Investigational Site

Fukuoka, 820-8505, Japan

Location

GSK Investigational Site

Fukushima, 960-1295, Japan

Location

GSK Investigational Site

Hiroshima, 734-8530, Japan

Location

GSK Investigational Site

Mie, 515-8544, Japan

Location

GSK Investigational Site

Nagasaki, 859-0497, Japan

Location

GSK Investigational Site

Niigata, 940-2085, Japan

Location

GSK Investigational Site

Osaka, 560-8552, Japan

Location

GSK Investigational Site

Osaka, 591-8555, Japan

Location

GSK Investigational Site

Osaka, 596-8501, Japan

Location

GSK Investigational Site

Shizuoka, 438-8550, Japan

Location

GSK Investigational Site

Tokyo, 142-8666, Japan

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Asthma-Chronic Obstructive Pulmonary Disease Overlap Syndrome; Bronchitis, Chronic

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Asthma; Bronchial Diseases; Respiratory Hypersensitivity; Hypersensitivity; Immune System Diseases; Bronchitis; Respiratory Tract Infections; Infections

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 17, 2019
• First Posted: May 21, 2019
• Study Start: June 13, 2019
• Primary Completion: June 30, 2022
• Study Completion: June 30, 2022
• Last Updated: February 22, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

JP (13)