Bronchiectasis With Acute ExacerbationNCT07346625
Impact of Comorbidities and Severity on Outcomes in Bronchiectasis Excerbations
An observational study of Bronchiectasis With Acute Exacerbation, run by Sohag University.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bronchiectasis With Acute Exacerbation
- What is being tested?
- Observational assessment of comorbidities and disease severity
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2026to 1 Dec 2026
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population will include adult patients (≥18 years) diagnosed with bronchiectasis who are admitted to the hospital with acute exacerbations. Patients will be recruited from the Department of Chest Diseases at Sohag University Hospital (or your hospital name). All eligible patients during the study period will be included consecutively. Data regarding demographic characteristics, comorbidities, disease severity scores (BSI or FACED), and clinical outcomes will be collected and analyzed.
Who may be able to join
- 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.
Who cannot join
- Patients younger than 18 years of age. Patients who refuse participation or whose medical records lack informed consent (if applicable).
About this study
Official title: Impact of Comorbiditries and Disease Severity on Clinical Outcomes of Patients With Acute Exacerbations of Bronchiectesis
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.
Read the 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.
- Conditions
- Bronchiectasis With Acute Exacerbation
- Being tested
- Observational assessment of comorbidities and disease severity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observational assessment of comorbidities and disease severityOther
> 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Observational assessment of comorbidities and disease severity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite Clinical treatment failure during Bronchiectasis Exacerbation
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
Measured: 30 days after exacerbation onset
Secondary outcomes (1)
correlation between disease severity and clinical treatment failure
correlation between baseline bronchiectasis severity ,assessed using the bronchiectasis severity index(BSI), and clinical treatment failure during exacerbations.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2026
- Study start1 Feb 2026 (estimated)
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bronchiectasis With Acute ExacerbationStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aliaa Elsayed Mahmoud, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07346625
- Sponsor's protocol ID
- Soh-Med-25-9-16MS
- Status last verified
- Dec 2025
- First submitted
- 16 Nov 2025
- Last updated
- 16 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared. The collected data will be used only for the current study purposes and will remain confidential according to institutional regulations.
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Comorbiditries and Disease Severity on Clinical Outcomes of Patients With Acute Exacerbations of Bronchiectesis
- ClinicalTrials.gov ID
- NCT07346625
- Acronym / sponsor ID
- Soh-Med-25-9-16MS
- Conditions
- Bronchiectasis With Acute Exacerbation
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Feb 2026 (estimated)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 16 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| adult bronchiectasis patient with acute excerbations | – | Other: Observational assessment of comorbidities and disease severityGroup 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will include adult patients (≥18 years) diagnosed with bronchiectasis who are admitted to the hospital with acute exacerbations. Patients will be recruited from the Department of Chest Diseases at Sohag University Hospital (or your hospital name). All eligible patients during the study period will be included consecutively. Data regarding demographic characteristics, comorbidities, disease severity scores (BSI or FACED), and clinical outcomes will be collected and analyzed.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Patients younger than 18 years of age. Patients who refuse participation or whose medical records lack informed consent (if applicable).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | adult bronchiectasis patient with acute excerbations |
Primary outcome
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
1 secondary outcome
correlation between disease severity and clinical treatment failure
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2026.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared. The collected data will be used only for the current study purposes and will remain confidential according to institutional regulations.
Related trials for Bronchiectasis With Acute Exacerbation
RecruitingObservational study
Study of Bronchiectasis and Associated Cardiovascular Comorbidities
Bronchiectasis
RecruitingObservational study
Study of Hospitalised Patients With Acute Respiratory Conditions
Acute Respiratory Disease, COPD Exacerbation Acute
RecruitingPhase 4
Azithromycin to Modify Bronchiectasis Exacerbation Risk
Non-cystic Fibrosis Bronchiectasis, Bronchiectasis Adult
Recruiting
Efficacy and Safety of Bronchoscopic Local Amikacin Instillation for Acute Exacerbations of Bronchiectasis in Adults: A Multicenter, Blinded, Randomized Controlled Trial
Bronchiectasis With Acute Exacerbation
RecruitingObservational study
Bronchiectasis Phenotype Identification Model
Bronchiectasis, Non-cystic Fibrosis Bronchiectasis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Bronchiectasis With Acute Exacerbation, run by Sohag University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 16 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite Clinical treatment failure during Bronchiectasis Exacerbation (time frame: 30 days after exacerbation onset). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2026.