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

NCT ID: NCT05068518

Last Updated: 2021-10-06

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 270 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-10-01
• Study Completion Date: 2023-12-31

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.

Conditions

Bronchiectasis Adult

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

No intervention

no intervention

Intervention Type: OTHER

Eligibility Criteria

Inclusion 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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chang Gung Memorial Hospital

OTHER

Sponsor Role: lead

Responsible Party

Lin, Chun-Yu

M.D

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Department of Thoracic Medicine, Chang Gung Memorial Hospital

Taoyuan District, , Taiwan

Countries

Taiwan

Central Contacts

Chun Yu Lin, MD

Role: CONTACT

pitiful1984@gmail.com

886-3-3281200 ext. 8467

Horng Chyuan Lin, MD

Role: CONTACT

Lin53424@gmail.com

886-3-3281200 ext. 8470

Facility Contacts

Horng-Chyuan Lin

Role: primary

Lin53424@gmail.com

Other Identifiers

MOST 110-2635-B-182A-006

Identifier Type: -

Identifier Source: org_study_id