Clinical trial NCT03957577: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
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
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2019-05-21
Enrollment: 70
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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).

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


Eligibility criteria: 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.

Primary outcomes:
measure: Number of participants with first evaluable moderate or severe AECOPD that have infectious or non-infectious etiology
timeFrame: Up to Month 12
measure: Microbiome composition of sputum in stable-state COPD as measured by bacterial ribosomal ribonucleic acid (rRNA) sequencing
timeFrame: Baseline (Screening visit or Month 0)
Secondary outcomes:
measure: Number of all-cause moderate and severe AECOPD per participants
timeFrame: Up to Month 12
measure: Microbiome composition of sputum in stable-state COPD as measured by bacterial rRNA sequencing
timeFrame: Baseline (Screening visit or Month 0)
measure: Microbiome composition of sputum during participant's first evaluable moderate or severe AECOPD
timeFrame: Up to Month 12
measure: 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)
timeFrame: Baseline (Screening visit or Month 0)
measure: 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
timeFrame: Baseline (Screening visit or Month 0)
measure: Number of EXACT events per participant over the course of 12 months
timeFrame: Up to Month 12
measure: Number of AECOPD events
timeFrame: Up to Month 12
measure: Severity of AECOPD according to healthcare utilization
timeFrame: Up to Month 12
measure: Severity of EXACT events according to EXACT total score
timeFrame: Up to Month 12
measure: Duration of AECOPD
timeFrame: Up to Month 12
measure: Duration of EXACT events
timeFrame: Up to Month 12
measure: Mean change in CAT score between stable-state COPD and participants' first evaluable moderate or severe AECOPD
timeFrame: Baseline (Screening visit or Month 0) and up to Month 12
measure: Mean change in CAT score over the course of 1 year
timeFrame: Baseline (Screening visit or Month 0) and up to Month 12
measure: Mean change in EXACT score
timeFrame: Baseline(Screening visit or Month 0) and up to Month 12
measure: Mean change in E-RS COPD total and subscale scores between stable-state COPD and participants' first evaluable moderate or severe AECOPD
timeFrame: Baseline (Screening visit or Month 0) and up to Month 12
measure: Mean change in E-RS: COPD total and subscale scores over the course of 1 year
timeFrame: Baseline (Screening visit or Month 0) and up to Month 12
measure: Mean change in Forced expiratory volume in 1 second (FEV1) between stable-state COPD, during participants' first evaluable moderate or severe AECOPD
timeFrame: Baseline (Screening visit or Month 0) and up to month 12
measure: Mean rate of AECOPD related healthcare resource utilization per participant
timeFrame: Up to Month 12
measure: Mean rate of non-AECOPD related healthcare resource utilization per participant
timeFrame: Up to Month 12
measure: Annual rate of AECOPD related healthcare resource utilization per participant
timeFrame: Up to Month 12
measure: Annual rate of non-AECOPD related healthcare resource utilization per participant
timeFrame: Up to Month 12
Other outcomes:
Locations:
city: Fukuoka
country: Japan
facility: GSK Investigational Site
city: Fukuoka
country: Japan
facility: GSK Investigational Site
city: Fukuoka
country: Japan
facility: GSK Investigational Site
city: Fukushima
country: Japan
facility: GSK Investigational Site
city: Hiroshima
country: Japan
facility: GSK Investigational Site
city: Mie
country: Japan
facility: GSK Investigational Site
city: Nagasaki
country: Japan
facility: GSK Investigational Site
city: Niigata
country: Japan
facility: GSK Investigational Site
city: Osaka
country: Japan
facility: GSK Investigational Site
city: Osaka
country: Japan
facility: GSK Investigational Site
city: Osaka
country: Japan
facility: GSK Investigational Site
city: Shizuoka
country: Japan
facility: GSK Investigational Site
city: Tokyo
country: Japan
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: