NCT05068518

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
270

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 28, 2021

Completed
3 days until next milestone

Study Start

First participant enrolled

October 1, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 6, 2021

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

October 6, 2021

Status Verified

September 1, 2021

Enrollment Period

2.2 years

First QC Date

September 28, 2021

Last Update Submit

September 28, 2021

Conditions

Keywords

bronchiectasis

Outcome Measures

Primary Outcomes (1)

  • Acute exacerbation

    visit ER or hsopitalization

    one year

Interventions

no intervention

Eligibility Criteria

Age20 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients (age ≥ 20 years old) with bronchiectasis were recruited from the Thoracic Outpatient Clinic of Chang Gung Memorial Hospital in Taiwan.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Thoracic Medicine, Chang Gung Memorial Hospital

Taoyuan District, 333, Taiwan

Location

MeSH Terms

Conditions

Bronchiectasis

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract Diseases

Central Study Contacts

Horng Chyuan Lin, MD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D

Study Record Dates

First Submitted

September 28, 2021

First Posted

October 6, 2021

Study Start

October 1, 2021

Primary Completion

December 31, 2023

Study Completion

December 31, 2023

Last Updated

October 6, 2021

Record last verified: 2021-09

Locations