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Clinical Trials/NCT05068518
NCT05068518
Unknown
Not Applicable

The Role of Airway Microbiota on Clinical Phenotypes and Disease Severity in Bronchiectasis

Chang Gung Memorial Hospital1 site in 1 country270 target enrollmentOctober 1, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Bronchiectasis Adult
Sponsor
Chang Gung Memorial Hospital
Enrollment
270
Locations
1
Primary Endpoint
Acute exacerbation
Last Updated
4 years ago

Overview

Brief Summary

Bronchiectasis is characterized pathologically by permanent bronchial dilatation and airway inflammation. The pathogenesis of the disease and the inflammatory, infective and molecular drivers of disease progression are not fully understood. The concept of "treatable traits" was proposed as biomarker-directed approach, based on the recognition of clinical phenotype and endotypes, help to personalized treatment options. Airway microbiota, including bacteria, NTM and fungus, have important but different inflammatory process in bronchiectasis. Our study will provide a new concept that airway microbiota might involve in the airway and systemic inflammation, mucus hypersecretion, as well as the airway damage, remodeling, and frequent exacerbations in bronchiectasis, thus leading to the deterioration of disease severity.

Bronchiectasis remains a major cause of respiratory morbidity and treatment is generally only partly successful. Our study will give more clues about the mechanisms on the inflammatory pathway and the probably different response among patients with different isolated microbiota from airways.

Detailed Description

Bronchiectasis is characterized pathologically by permanent bronchial dilatation and airway inflammation, and clinically by productive cough, hemoptysis and periodic infectious exacerbations. The pathogenesis of the disease and the inflammatory, infective and molecular drivers of disease progression are not fully understood. Current available therapeutic options have shown only a modest impact on disease outcomes in randomized clinical trials. The concept of "treatable traits" was proposed as biomarker-directed approach, based on the recognition of clinical phenotype and endotypes, help to personalized treatment options. Potential treatable traits of airways disease into four broad categories: pulmonary, extra-pulmonary, etiological, and behavior and lifestyle treatable traits. Airway microbiota, including bacteria, NTM and fungus, have important but different inflammatory process in bronchiectasis. Our study will provide a new concept that airway microbiota might involve in the airway and systemic inflammation, mucus hypersecretion, as well as the airway damage, remodeling, and frequent exacerbations in bronchiectasis, thus leading to the deterioration of disease severity. Bronchiectasis remains a major cause of respiratory morbidity and treatment is generally only partly successful. Our study will give more clues about the mechanisms by which the immunomodulatory medications (macrolides) on the inflammatory pathway and the probably different response among patients with different isolated microbiota from airways. Thus, our results will not only shed light on the airway microbiota inflammatory mechanisms responsible for disease severity, but also provide a new therapeutic direction.

Registry
clinicaltrials.gov
Start Date
October 1, 2021
End Date
December 31, 2023
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Chang Gung Memorial Hospital
Responsible Party
Principal Investigator
Principal Investigator

Lin, Chun-Yu

M.D

Chang Gung Memorial Hospital

Eligibility Criteria

Inclusion Criteria

  • The inclusion criteria were as follows: bronchiectasis documented on chest HRCT, idiopathic etiology of bronchiectasis, chronic sputum production (daily sputum ≥ 10 ml), absence of other major pulmonary diagnoses, and steady state defined by the absence of change of symptoms noted by the patient over the past 3 weeks

Exclusion Criteria

  • The exclusion criteria were as follows: bronchiectasis with defined etiology (i.e, post-tuberculosis, primary ciliary dyskinesia, allergic bronchopulmonary aspergillosis), common variable immunodeficiency, and use of antibiotics within the last 3 weeks. Patients with hepatic failure, malignancy, or pregnancy were also excluded.

Outcomes

Primary Outcomes

Acute exacerbation

Time Frame: one year

visit ER or hsopitalization

Study Sites (1)

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