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

NCT04865861 | Unknown

• 1 other identifier: GIRH-2020-156
• Study Type: observational
• Target: 220
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Bronchiectasis Adult; Chronic Obstructive Pulmonary Disease; Overlap; Microbiome

Keywords

Bronchiectasis; Chronic Obstructive Pulmonary Disease; overlap; microbiome; exacerbation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• α-diversity

  1 hour

• β-diversity

  1 hour

• The positive result of bacteria culture and viral PCR.

  1 hour

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This is a single-center prospective observational study in which we will enroll the patients diagnosed as COPD, bronchiectasis or overlap (with or without chronic cough, daily sputum production) from the First Affiliated Hospital of Guangzhou Medical University between May 2020 and June 2023.

You may qualify if:

• Diagnosed as COPD, bronchiectasis or overlap based on HRCT and lung function test.
• Aged between 18 and 80 years.

You may not qualify if:

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

Sponsors & Collaborators

• Guangzhou Medical University: lead

Study Sites (1)

The First Affiliated Hospital of Guangzhou Medical University.

Guangzhou, Guangdong, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

serum; plasma; blood cell; sputum

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Bronchiectasis

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Bronchial Diseases

Study Officials

• Weijie Guan, PhD

  The First Affiliated Hospital of Guangzhou Medical University

  PRINCIPAL INVESTIGATOR

• Nanshan Zhong, PhD

  The First Affiliated Hospital of Guangzhou Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhenfeng He, MD

CONTACT

8602083062882; zfHe_2019@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle investigator

Study Record Dates

• First Submitted: April 25, 2021
• First Posted: April 29, 2021
• Study Start: May 1, 2021
• Primary Completion: June 30, 2023
• Study Completion: June 30, 2023
• Last Updated: May 4, 2021

Record last verified: 2021-05

Locations

CN (1)