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Not yet recruiting NCT07346625

Impact of Comorbidities and Severity on Outcomes in Bronchiectasis Excerbations

Observational Bronchiectasis With Acute Exacerbation

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Observational assessment of comorbidities and disease severity.
Who it may be relevant to
Registry conditions: Bronchiectasis With Acute Exacerbation. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Impact of Comorbiditries and Disease Severity on Clinical Outcomes of Patients With Acute Exacerbations of Bronchiectesis

Overview

Acute exacerbations of bronchiectasis are associated with variable outcomes depending on patient factors. Comorbidities such as COPD, diabetes, and cardiovascular disease, as well as disease severity scores, significantly influence hospitalization rates, length of stay, need for intensive care, and mortality. Understanding these associations helps in risk stratification, guiding management, and improving prognosis in affected patients.

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.

Interventions

  • Other Observational assessment of comorbidities and disease severity
    \> 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.

Primary outcome measures

  • Composite Clinical treatment failure during Bronchiectasis Exacerbation [Time frame: 30 days after exacerbation onset]
Secondary outcome measures (1)
  • correlation between disease severity and clinical treatment failure [Time frame: 1 year]

Eligibility criteria

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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07346625 · Soh-Med-25-9-16MS

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗