Skip to main content
OpenTrials
Completed

NCT Number: NCT03957577

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

GSK Investigational Site, Fukuoka, Japan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Prospective observational cohort study

Other

Prospective observational cohort study

Primary outcomes

  1. Number of participants with first evaluable moderate or severe AECOPD that have infectious or non-infectious etiology

    Time frame: Up to Month 12

  2. 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)

Secondary outcomes

  1. Number of all-cause moderate and severe AECOPD per participants

    Time frame: Up to Month 12

  2. Microbiome composition of sputum in stable-state COPD as measured by bacterial rRNA sequencing

    Time frame: Baseline (Screening visit or Month 0)

  3. Microbiome composition of sputum during participant's first evaluable moderate or severe AECOPD

    Time frame: Up to Month 12

  4. 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)

  5. 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)

  6. Number of EXACT events per participant over the course of 12 months

    Time frame: Up to Month 12

    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.

  7. Number of AECOPD events

    Time frame: Up to Month 12

  8. Severity of AECOPD according to healthcare utilization

    Time frame: Up to Month 12

  9. Severity of EXACT events according to EXACT total score

    Time frame: Up to Month 12

  10. Duration of AECOPD

    Time frame: Up to Month 12

  11. Duration of EXACT events

    Time frame: Up to Month 12

  12. Mean change in CAT score between stable-state COPD and participants' first evaluable moderate or severe AECOPD

    Time frame: Baseline (Screening visit or Month 0) and up to Month 12

    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).

  13. Mean change in CAT score over the course of 1 year

    Time frame: Baseline (Screening visit or Month 0) and up to Month 12

    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).

  14. Mean change in EXACT score

    Time frame: Baseline(Screening visit or Month 0) and up to Month 12

    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.

  15. Mean change in E-RS COPD total and subscale scores between stable-state COPD and participants' first evaluable moderate or severe AECOPD

    Time frame: Baseline (Screening visit or Month 0) and up to Month 12

    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.

  16. Mean change in E-RS: COPD total and subscale scores over the course of 1 year

    Time frame: Baseline (Screening visit or Month 0) and up to Month 12

    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.

  17. 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

  18. Mean rate of AECOPD related healthcare resource utilization per participant

    Time frame: Up to Month 12

  19. Mean rate of non-AECOPD related healthcare resource utilization per participant

    Time frame: Up to Month 12

  20. Annual rate of AECOPD related healthcare resource utilization per participant

    Time frame: Up to Month 12

  21. Annual rate of non-AECOPD related healthcare resource utilization per participant

    Time frame: Up to Month 12

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

A Prospective, Epidemiological, Cohort Study to Assess the Aetiology of Acute Exacerbations of Chronic Obstructive Pulmonary Disease in Japan

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
May 21, 2019
Registry last updated
Feb 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.