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Clinical Trials/NCT04865861
NCT04865861
Unknown
Not Applicable

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

Guangzhou Medical University1 site in 1 country220 target enrollmentMay 1, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Bronchiectasis Adult
Sponsor
Guangzhou Medical University
Enrollment
220
Locations
1
Primary Endpoint
The number of exacerbation events
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 1, 2021
End Date
June 30, 2023
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Guangzhou Medical University
Responsible Party
Principal Investigator
Principal Investigator

Zhenfeng He

Principle investigator

Guangzhou Medical University

Eligibility Criteria

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.

Outcomes

Primary Outcomes

The number of exacerbation events

Time Frame: 1 year

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.

Secondary Outcomes

  • The positive result of bacteria culture and viral PCR.(1 hour)
  • α-diversity(1 hour)
  • β-diversity(1 hour)

Study Sites (1)

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