The Characteristic of Airway Microbiome Profiling of COPD-bronchiectasis Overlap Patients and Its Association With Acute Exacerbation

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

The Characteristic of Airway Microbiome Profiling of Chronic Obstructive Pulmonary Disease-bronchiectasis Overlap Patients and Its Association With Acute Exacerbation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04865861
• Other study ID #: GIRH-2020-156
• Status: Recruiting
• Start date: May 1, 2021
• Est. completion date: June 30, 2023

Study information

• Verified date: May 2021
• Source: Guangzhou Medical University
• Contact: Zhenfeng He, MD
• Phone: 8602083062882
• Email: zfHe_2019[@]163.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

The overlap between chronic obstructive pulmonary disease (COPD) and bronchiectasis is a neglected area of research, and it is not covered by guidelines for clinical practice.

COPD and bronchiectasis share common symptoms of cough with sputum production and susceptibility to recurrent exacerbations driven by new or persistent infection.

Physiological criteria for the diagnosis of COPD and structural criteria for the diagnosis of bronchiectasis create the possibility for individual patients to fulfil both, resulting conceptually in either co-diagnosis or an overlap syndrome between the two conditions. The prevalence of this overlap will vary depending on the respective prevalence of COPD and bronchiectasis in the population under consideration.

A recent study of 201 COPD patients with airway wall abnormalities typical of bronchiectasis confirmed an association with exacerbations and was predictive of mortality over 48 months. A further, single-centre study demonstrated a near three-fold increased mortality rate, with patients with bronchiectasis and associated COPD having a 5-year mortality of 55%, compared with 20% in those with bronchiectasis without COPD. Airflow obstruction is perhaps best considered one marker of disease severity in bronchiectasis.

Disease-associated exacerbations have a major effect on patient healthcare costs as well as quality of life due to increased lung damage and mortality risk. Microorganisms such as Pseudomonas aeruginosa and, to a lesser extent, other Gram-negative and Gram-positive microorganisms identified in culture, have been linked to disease progression, poor clinical outcomes in bronchiectasis and driving airway neutrophil-mediated inflammation. The microbiome has the potential to provide valuable information regarding disease phenotype/endotype, treatment responses and targets for future therapy.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 220
• Est. completion date: June 30, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Diagnosed as COPD, bronchiectasis or overlap based on HRCT and lung function test.

• Aged between 18 and 80 years.

Exclusion Criteria:

• Patients with active tuberculosis, traction bronchiectasis, malignancy, and severe systemic diseases.

Related Conditions & MeSH terms

• Bronchiectasis
• Bronchiectasis Adult
• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Microbiome
• Pulmonary Disease, Chronic Obstructive

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Guangzhou Medical University.	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Guangzhou Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The number of exacerbation events	The exacerbation of bronchiectasis is defined as a deterioration in three or more of the following key symptoms for at least 48 h: cough; sputum volume and/or consistency; sputum purulence; breathlessness and/or exercise tolerance; fatigue and/or malaise; haemoptysis AND a clinician determines that a change in bronchiectasis treatment is required.	1 year
Secondary	a-diversity	a-diversity is a measure of how diverse a sample is based on how many species here are (richness) and how abundant each species is (evenness) within that sample.	1 hour
Secondary	ß-diversity	ß-diversity is used to show how different samples are from each other, based on ifferences in bacterial presence, abundance or a phylogenetic tree	1 hour
Secondary	The positive result of bacteria culture and viral PCR.	The positive result of bacteria is defined as at least one positive potentially-pathogenic bacteria being cultured from sputum (Haemophilus influenzae, Moraxella catarrhalis, Streptococcus pneumoniae, Pseudomonas aeruginosa, or Staphylococcus aureus).; The positive result of viral is defined as at least one positive viral PCR (HRV, RSV, influenza virus, parainfluenza virus, human metapneumovirus, adenovirus, human bocavirus, or coronavirus) from sputum.	1 hour