BronchiectasisNCT05783869
Study of Bronchiectasis and Associated Cardiovascular Comorbidities
An observational study of Bronchiectasis, run by Assiut University at 1 site in Egypt.
Trial summary
Effect of cardiovascular comorbidities on disease severity and quality of life in Patients with acute exacerbation of non-cystic fibrosis bronchiectasis Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Bronchiectasis
- What is being tested?
- Echocardiography
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 25 Mar 2023to 2 Nov 2026
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: all patients at the study period attending the chest department at Assuit university
Who may be able to join
- Any Patients with Bronchiectasis had no comorbidities other than cardiovascular comorbidities during the study period.
Who cannot join
- Any Patients who refuse to participate in the study.
- Any other comorbidity or end-organ failure may affect the study's result.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Assiut unviresty - Faculty of Medicine
Asyut, 71511
Ahmad Shaddad, Lecturer, +201111171930, shaddad_ahmad@yahoo.com
About this study
Official title: Effect of Cardiovascular Comorbidities on Disease Severity and Quality of Life in Patients With Acute Exacerbation of Non-cystic Fibrosis Bronchiectasis
Effect of cardiovascular comorbidities on disease severity and quality of life in Patients with acute exacerbation of non-cystic fibrosis bronchiectasis
Read the detailed description
The study will include patients with bronchiectasis, and in an attempt to correlate the effect and burden of cardiovascular comorbidities in those patients, we will study the quality of life in those patients in comparison to the control group ( patients with bronchiectasis and without any other comorbidities) using SF-36 quality of life questionnaire. We will also study the inflammatory markers in both groups using D-dimer, BNP, and CRP and correlate them with the frequency of hospital admission, the severity of symptoms, and the general health state.
- Conditions
- Bronchiectasis
- Being tested
- Echocardiography
- Medical subject headings
- Bronchiectasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EchocardiographyDevice
Also called Pulmonary function test, Routine laboratory investigations and inflammatory markers
echocardiographic study of both groups
| Study group | Role | What they receive |
|---|---|---|
| Patient with bronchiectasis and cardiovascular comorbidities | Patients with Bronchiectasis had no comorbidities other than cardiovascular comorbidities during the study period. Receives: Device: Echocardiography | |
| Patients with bronchiectasis and without cardiovascular comorbidities | Patients with Bronchiectasis had no comorbidities. Receives: Device: Echocardiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
assessment of BNP (Brain natriuretic peptide) pg/ml levels in patients with bronchiectasis and cardiovascular comorbidities.
Serum BNP (Brain natriuretic peptide) pg/ml will be compared in both groups.
Measured: March 2023 to September 2023
Assessment of Quality of life in patients and control groups using The Short Form (36) Health Survey (SF-36)
The Short Form (36) Health Survey will be performed in both groups. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.
Measured: March 2023 to September 2023
Secondary outcomes (1)
Hospitalization frequency in patient group compared to control group.
Number of hospital admission in the last year will be compared in both groups.
Measured: March 2023 to September 2023
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2023
- Study start25 Mar 2023
- Primary completion1 Sep 2026 (estimated)
- Study completion2 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BronchiectasisStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Collaborators
- Aliae AR Mohamed Hussein [ahussein
- Responsible party
- Principal investigator, Ahmad Shaddad, Assiut University
- Investigators
- Ahmad Shaddad, Principal investigator, Assuit University Faculty of MedicineAhmad Shaddad, Principal investigator, Assiut University Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05783869
- Sponsor's protocol ID
- 23455668
- Status last verified
- May 2026
- First submitted
- 12 Feb 2023
- Last updated
- 13 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Cardiovascular Comorbidities on Disease Severity and Quality of Life in Patients With Acute Exacerbation of Non-cystic Fibrosis Bronchiectasis
- ClinicalTrials.gov ID
- NCT05783869
- Acronym / sponsor ID
- 23455668
- Conditions
- Bronchiectasis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Collaborators
- Aliae AR Mohamed Hussein [ahussein
- Study start
- 25 Mar 2023 (actual)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 2 Nov 2026 (estimated)
- First posted
- 24 Mar 2023 (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.
Effect of cardiovascular comorbidities on disease severity and quality of life in Patients with acute exacerbation of non-cystic fibrosis bronchiectasis
Detailed description
The study will include patients with bronchiectasis, and in an attempt to correlate the effect and burden of cardiovascular comorbidities in those patients, we will study the quality of life in those patients in comparison to the control group ( patients with bronchiectasis and without any other comorbidities) using SF-36 quality of life questionnaire. We will also study the inflammatory markers in both groups using D-dimer, BNP, and CRP and correlate them with the frequency of hospital admission, the severity of symptoms, and the general health state.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient with bronchiectasis and cardiovascular comorbidities | – | Device: EchocardiographyPatients with Bronchiectasis had no comorbidities other than cardiovascular comorbidities during the study period. |
| Patients with bronchiectasis and without cardiovascular comorbidities | – | Device: EchocardiographyPatients with Bronchiectasis had no comorbidities. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- all patients at the study period attending the chest department at Assuit university
Key inclusion criteria (1 listed)
- Any Patients with Bronchiectasis had no comorbidities other than cardiovascular comorbidities during the study period.
Key exclusion criteria (2 listed)
- Any Patients who refuse to participate in the study.
- Any other comorbidity or end-organ failure may affect the study's result.
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 |
|---|---|---|
| EchocardiographyAlso: Pulmonary function test, Routine laboratory investigations and inflammatory markersechocardiographic study of both groups | Device | Patient with bronchiectasis and cardiovascular comorbidities, Patients with bronchiectasis and without cardiovascular comorbidities |
Primary outcome
assessment of BNP (Brain natriuretic peptide) pg/ml levels in patients with bronchiectasis and cardiovascular comorbidities.
Time frame: March 2023 to September 2023
Serum BNP (Brain natriuretic peptide) pg/ml will be compared in both groups.
Assessment of Quality of life in patients and control groups using The Short Form (36) Health Survey (SF-36)
Time frame: March 2023 to September 2023
The Short Form (36) Health Survey will be performed in both groups. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.
1 secondary outcome
Hospitalization frequency in patient group compared to control group.
Time frame: March 2023 to September 2023
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 13 May 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Bronchiectasis
RecruitingObservational study
Natural History of Bronchiectasis
Bronchiectasis, Cystic Fibrosis
Recruiting
Long-term Evaluation of the SIMEOX Device at Home in Non-cystic Fibrosis Bronchiectasis
Non-cystic Fibrosis Bronchiectasis
Recruiting
Diagnostic Value of Oropharyngeal Suction and Effect of Respiratory Physiotherapy on the Detection of Microorganisms in the Pediatric Patient
Cystic Fibrosis (CF), Bronchiectasis, Non-Cystic Fibrosis
Enrolling by invitationObservational study
Investigating Novel Strategies in Pediatric Immune Responses and Microbiome Environment: Comprehensive Lung Disease Investigation in Children.
Lung Diseases
RecruitingPhase 3
The AIRTIVITY™ Study: A Study to Find Out Whether BI 1291583 Helps People With Bronchiectasis
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.
Ahmad Shaddad principal investigator
Assuit University Faculty of Medicine
Ahmad Shaddad principal investigator
Assiut University Faculty of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bronchiectasis, run by Assiut University at 1 site in Egypt.
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 2 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: looking for participants now, as of the sponsor's last update on 13 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Contact Shaadad Shaddad, MD (+201111171930, shaddad_ahmad@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
assessment of BNP (Brain natriuretic peptide) pg/ml levels in patients with bronchiectasis and cardiovascular comorbidities. (time frame: March 2023 to September 2023). The study lists 2 primary outcomes in all. 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 13 May 2026.