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

  • STATUS
    Recruiting
  • End date
    Jun 30, 2022
  • participants needed
    70
  • sponsor
    GlaxoSmithKline
Updated on 5 August 2021
corticosteroids
dyspnea
obstruction
cough
wheezing
respiratory symptom
bronchodilator
spirometry

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

Details
Condition Chronic Obstructive Lung Disease, COPD (Chronic Obstructive Pulmonary Disease)
Treatment spirometry, blood sampling, Chest X-ray, Telephonic interviews, Modified American Thoracic Society and National Heart and Lung Institute-Division of Lung Disease Respiratory (Mod. ATS-DLD-078), Modified Medical Research Council (mMRC) Dyspnea Scale, Exacerbations of Chronic Pulmonary Disease Tool (EXACT), COPD Assessment Test (CAT), Evaluating Respiratory Symptoms in COPD (E-RS: COPD), Electronic Diary (eDiary), Sputum Sampling, Prospective observational cohort study
Clinical Study IdentifierNCT03957577
SponsorGlaxoSmithKline
Last Modified on5 August 2021

Eligibility

Yes No Not Sure

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
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