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

GlaxoSmithKline (GSK)

Status: Completed

Conditions: Pulmonary Disease, Chronic Obstructive

Treatments: Other: Prospective observational cohort study

Study type: Observational

Funder types: Industry

Identifiers

NCT03957577

208636

Details and patient eligibility

About

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

Enrollment: 70 patients

Sex: All

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

70 participants in 1 patient group

All participants

Description:

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

Treatment:

Other: Prospective observational cohort study