- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07346625
Impact of Comorbidities and Severity on Outcomes in Bronchiectasis Excerbations
Impact of Comorbiditries and Disease Severity on Clinical Outcomes of Patients With Acute Exacerbations of Bronchiectesis
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Bronchiectasis is a chronic respiratory condition characterized by permanent and abnormal dilatation of the bronchi, often associated with recurrent infections, impaired mucociliary clearance, and progressive lung damage. Acute exacerbations represent a major clinical problem, contributing to significant morbidity, reduced quality of life, and increased healthcare burden.
The clinical outcomes of patients experiencing acute exacerbations of bronchiectasis are not uniform, and multiple factors influence their prognosis. Among these, comorbidities and disease severity play crucial roles. Comorbidities such as chronic obstructive pulmonary disease (COPD), asthma, cardiovascular diseases, diabetes mellitus, and chronic renal impairment can increase susceptibility to exacerbations and worsen their clinical course. The presence of these comorbid conditions is often linked to prolonged hospital stays, higher rates of intensive care admission, frequent readmissions, and increased mortality.
Similarly, the severity of underlying bronchiectasis, often assessed through validated scoring systems (e.g., Bronchiectasis Severity Index [BSI], FACED score), is strongly correlated with outcomes during exacerbations. Patients with more severe disease tend to experience more frequent and severe exacerbations, impaired lung function, greater need for intravenous antibiotics, and higher risk of complications.
Therefore, assessing both comorbidity burden and disease severity is critical in predicting outcomes, guiding clinical decision-making, and tailoring individualized management strategies for patients presenting with acute exacerbations of bronchiectasis. A comprehensive understanding of these relationships will aid in early risk stratification, optimization of treatment, and potentially reduction of adverse outcomes in this vulnerable patient population.
Study Type
Enrollment (Estimated)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Adults (≥18 years) admitted with a diagnosis of "Bronchiectasis with acute exacerbation". The bronchiectasis exacerbation is diagnosed based on deterioration in three or more of the following main symptoms for 48h at least: cough, sputum volume or sputum consistency, purulent sputum, breathlessness or exercise tolerance, fatigue or malaise, hemoptysis, and the requirement of a change in the bronchiectasis treatment as determined by a clinician.
Exclusion Criteria:
- Patients younger than 18 years of age. Patients who refuse participation or whose medical records lack informed consent (if applicable).
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
adult bronchiectasis patient with acute excerbations
Group 1: Mild-to-Moderate Disease Severity Patients diagnosed with bronchiectasis who present with acute exacerbations and have mild to moderate disease severity scores (based on BSI or FACED scoring). Data on comorbidities, clinical outcomes, and hospital stay will be recorded. Group 2: Severe Disease Severity Patients with acute exacerbations of bronchiectasis classified as severe according to BSI or FACED score. These patients are expected to have higher comorbidity burden and worse clinical outcomes. Alternative grouping (if by comorbidity burden): Group A: With Significant Comorbidities Patients with one or more major comorbidities such as COPD, diabetes, or cardiovascular disease. Group B: Without Significant Comorbidities Patients without major comorbid conditions, serving as a comparison group. |
> This study involves no active intervention.
Data will be collected from patients with acute exacerbations of bronchiectasis to assess the impact of comorbidities and disease severity on clinical outcomes such as hospital stay, ICU admission, and mortality.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Composite Clinical treatment failure during Bronchiectasis Exacerbation
Time Frame: 30 days after exacerbation onset
|
composite clinical treatment failure,defined as the occurrence of any of the following events within 30 days of bronchiectasis exacerbation onset: 1.hospitalization related to the exacerbation 2.escalation or change of antibiotic therapy 3.Admission to the intensive care unit 4.Death from any cause
|
30 days after exacerbation onset
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
correlation between disease severity and clinical treatment failure
Time Frame: 1 year
|
correlation between baseline bronchiectasis severity ,assessed using the bronchiectasis severity index(BSI), and clinical treatment failure during exacerbations.
|
1 year
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Soh-Med-25-9-16MS
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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