Correlation of Inflammatory Markers and Radiological Findings in Stable Bronchiectasis PatientsNCT07495982
Correlation of Inflammatory Markers and Radiological Findings in Stable Bronchiectasis Patients With Exacerbation Phenotype
An observational study of Correlation of Inflammatory Markers and Radiological Findings in Stable Bronchiectasis Patients, run by Sohag University at 1 site in Egypt.
Trial summary
Bronchiectasis, also referred to as non-cystic fibrosis (non-CF) bronchiectasis, is a chronic respiratory disease defined by abnormal and irreversible dilatation of the bronchi (1). Dilatation of the bronchial lumen predisposes to infection (2). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Correlation of Inflammatory Markers and Radiological Findings in Stable Bronchiectasis Patients
- What is being tested?
- Inflammatory Markers and Radiological Findings
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Nov 2025to 1 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients at Department of Chest Diseases and Outpatient Chest Clinic, Sohag University Hospitals.
Who may be able to join
- adult patients (≥18 years) with non-cystic fibrosis bronchiectasis confirmed by High Resolution Computed Tomography (HRCT).
Who cannot join
- Patients with cystic fibrosis-related bronchiectasis.
- Patients with active pulmonary tuberculosis.
- Patients with chronic debilitating diseases e.g. advanced hepatic or renal diseases.
- Patients with primary autoimmune or malignancy requiring immunosuppressive therapy at the time of the marker measurement.
- Patients refusing participation.
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
Faculty of medicine
Sohag, 82515
Mayar Magdy, resident, +201061041871, mayar_magdy_post@med.sohag.edu.eg
About this study
Bronchiectasis, also referred to as non-cystic fibrosis (non-CF) bronchiectasis, is a chronic respiratory disease defined by abnormal and irreversible dilatation of the bronchi (1). Dilatation of the bronchial lumen predisposes to infection (2). Recurrent infection and airway inflammation leads to tissue damage and inflammation that leads to excess mucus production and delayed mucociliary clearance, predisposing the patient to recurrent and chronic infections (3). This in turn creates a cycle of further tissue damage and infection (4), leading to recurrent exacerbations, hospitalizations and loss of lung function. Non-CF bronchiectasis patients who experience frequent exacerbations (≥2 per year) represent a high-risk group with accelerated disease progression.Bronchiectasis has become a major health concern due to its increasing prevalence and associated healthcare costs (5). The disease can be caused by many different etiologies, which may be causative, synergistic, or coincidental, depending on the manner in which they interact and it is clinically characterized by a variety of symptoms, including cough, sputum production and airway infection, and can often present with recurrent exacerbations (6). An exacerbation is generally defined as a sustained clinical deterioration characterized by an increase in symptoms, which may include increased cough, increased sputum volume or change in consistency, increased sputum purulence (color change), increased breathlessness and/or reduced exercise tolerance, increased fatigue and/or malaise, hemoptysis for at least 48 h requiring a change in treatment.
Recurrent exacerbations are related to elevated systemic and airway inflammation, deterioration of lung function and progression of the disease(7). In addition to known etiologies of bronchiectasis, several other diseases may occur at any stage of bronchiectasis and are likely major contributors to increased hospitalizations, healthcare utilization and socioeconomic costs. These include cardiovascular disorders, gastro-oesophageal reflux disease (GORD), psychological illnesses, pulmonary hypertension, cognitive impairment, and lung, oesophageal and hematological malignancies (8-9).
- Conditions
- Correlation of Inflammatory Markers and Radiological Findings in Stable Bronchiectasis Patients
- Being tested
- Inflammatory Markers and Radiological Findings
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inflammatory Markers and Radiological FindingsOther
- Functional assessment: the available functional assessment will be performed.
- Laboratory: CBC, neutrophil: lymphocyte ratio (NLR), platelet : lymphocyte ratio (PLR), C-reactive protein (CRP), ESR, renal and liver function, serum albumin level.
- Microbiology: Sputum Gram stain, culture and sensitivity when indicated.
- Radiology: High Resolution CT chest with lobar assessment and severity scoring (Reiff, Bhalla, BRICS).
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation of the inflammatory markers and radiological findings with exacerbation phenotype.
Measured: 1/11/2026
Secondary outcomes (1)
Correlation of the inflammatory markers and radiological findings with QoL scores and hospitalizations
Measured: 1/11/2026
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2026
- Study start1 Nov 2025
- Primary completion1 Nov 2026 (estimated)
- Study completion1 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Correlation of Inflammatory Markers and Radiological Findings in Stable Bronchiectasis PatientsStudies 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)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mayar Magdy Mohamed, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07495982
- Sponsor's protocol ID
- Soh-Med-26-2-13MS
- Status last verified
- Mar 2026
- First submitted
- 22 Mar 2026
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Barker AF. Bronchiectasis. N Engl J Med. 2002 May 2;346(18):1383-93. doi: 10.1056/NEJMra012519. No abstract available.
PubMed 11986413Polverino E, Dimakou K, Hurst J, Martinez-Garcia MA, Miravitlles M, Paggiaro P, Shteinberg M, Aliberti S, Chalmers JD. The overlap between bronchiectasis and chronic airway diseases: state of the art and future directions. Eur Respir J. 2018 Sep 15;52(3):1800328. doi: 10.1183/13993003.00328-2018. Print 2018 Sep.
PubMed 30049739Olveira C, Olveira G, Espildora F, Giron RM, Munoz G, Quittner AL, Martinez-Garcia MA. Validation of a Quality of Life Questionnaire for Bronchiectasis: psychometric analyses of the Spanish QOL-B-V3.0. Qual Life Res. 2014 May;23(4):1279-92. doi: 10.1007/s11136-013-0560-0. Epub 2013 Oct 19.
PubMed 24142190Menendez R, Mendez R, Amara-Elori I, Reyes S, Montull B, Feced L, Alonso R, Amaro R, Alcaraz V, Fernandez-Barat L, Torres A. Systemic Inflammation during and after Bronchiectasis Exacerbations: Impact of Pseudomonas aeruginosa. J Clin Med. 2020 Aug 13;9(8):2631. doi: 10.3390/jcm9082631.
PubMed 32823681Keir HR, Shoemark A, Dicker AJ, Perea L, Pollock J, Giam YH, Suarez-Cuartin G, Crichton ML, Lonergan M, Oriano M, Cant E, Einarsson GG, Furrie E, Elborn JS, Fong CJ, Finch S, Rogers GB, Blasi F, Sibila O, Aliberti S, Simpson JL, Huang JTJ, Chalmers JD. Neutrophil extracellular traps, disease severity, and antibiotic response in bronchiectasis: an international, observational, multicohort study. Lancet Respir Med. 2021 Aug;9(8):873-884. doi: 10.1016/S2213-2600(20)30504-X. Epub 2021 Feb 17.
PubMed 33609487El-Gazzar AG, Kamel MH, Elbahnasy OKM, El-Naggar ME. Prognostic value of platelet and neutrophil to lymphocyte ratio in COPD patients. Expert Rev Respir Med. 2020 Jan;14(1):111-116. doi: 10.1080/17476348.2019.1675517. Epub 2019 Oct 13.
PubMed 31577911Taylan M, Demir M, Kaya H, Selimoglu Sen H, Abakay O, Carkanat AI, Abakay A, Tanrikulu AC, Sezgi C. Alterations of the neutrophil-lymphocyte ratio during the period of stable and acute exacerbation of chronic obstructive pulmonary disease patients. Clin Respir J. 2017 May;11(3):311-317. doi: 10.1111/crj.12336. Epub 2015 Aug 6.
PubMed 26096858Hu B, Yang XR, Xu Y, Sun YF, Sun C, Guo W, Zhang X, Wang WM, Qiu SJ, Zhou J, Fan J. Systemic immune-inflammation index predicts prognosis of patients after curative resection for hepatocellular carcinoma. Clin Cancer Res. 2014 Dec 1;20(23):6212-22. doi: 10.1158/1078-0432.CCR-14-0442. Epub 2014 Sep 30.
PubMed 25271081Posadas T, Oscullo G, Zaldivar E, Villa C, Dobarganes Y, Giron R, Olveira C, Maiz L, Garcia-Clemente M, Sibila O, Golpe R, Rodriguez J, Barreiro E, Rodriguez JL, Menendez R, Prados C, de la Rosa D, Martinez-Garcia MA; Spanish Registry of Bronchiectasis Group (RIBRON); SPANISH REGISTRY OF BRONCHIECTASIS GROUP. C-Reactive Protein Concentration in Steady-State Bronchiectasis: Prognostic Value of Future Severe Exacerbations. Data From the Spanish Registry of Bronchiectasis (RIBRON). Arch Bronconeumol (Engl Ed). 2021 Jan;57(1):21-27. doi: 10.1016/j.arbres.2019.12.017. Epub 2020 Apr 21. English, Spanish.
PubMed 32331706Lee JL, Oh ES, Lee RW, Finucane TE. Serum Albumin and Prealbumin in Calorically Restricted, Nondiseased Individuals: A Systematic Review. Am J Med. 2015 Sep;128(9):1023.e1-22. doi: 10.1016/j.amjmed.2015.03.032. Epub 2015 Apr 23.
PubMed 25912205Aliberti S, Lonni S, Dore S, McDonnell MJ, Goeminne PC, Dimakou K, Fardon TC, Rutherford R, Pesci A, Restrepo MI, Sotgiu G, Chalmers JD. Clinical phenotypes in adult patients with bronchiectasis. Eur Respir J. 2016 Apr;47(4):1113-22. doi: 10.1183/13993003.01899-2015. Epub 2016 Feb 4.
PubMed 26846833Chen YF, Hou HH, Chien N, Lu KZ, Chen YY, Hung ZC, Chien JY, Wang HC, Yu CJ. Type 2 Biomarkers and Their Clinical Implications in Bronchiectasis: A Prospective Cohort Study. Lung. 2024 Oct;202(5):695-709. doi: 10.1007/s00408-024-00707-0. Epub 2024 Jun 17.
PubMed 38884647
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation of Inflammatory Markers and Radiological Findings in Stable Bronchiectasis Patients With Exacerbation Phenotype
- ClinicalTrials.gov ID
- NCT07495982
- Acronym / sponsor ID
- Soh-Med-26-2-13MS
- Conditions
- Correlation of Inflammatory Markers and Radiological Findings in Stable Bronchiectasis Patients
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Nov 2025 (actual)
- Primary completion
- 1 Nov 2026 (estimated)
- Study completion
- 1 Nov 2026 (estimated)
- First posted
- 27 Mar 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.
Bronchiectasis, also referred to as non-cystic fibrosis (non-CF) bronchiectasis, is a chronic respiratory disease defined by abnormal and irreversible dilatation of the bronchi (1). Dilatation of the bronchial lumen predisposes to infection (2). Recurrent infection and airway inflammation leads to tissue damage and inflammation that leads to excess mucus production and delayed mucociliary clearance, predisposing the patient to recurrent and chronic infections (3). This in turn creates a cycle of further tissue damage and infection (4), leading to recurrent exacerbations, hospitalizations and loss of lung function. Non-CF bronchiectasis patients who experience frequent exacerbations (≥2 per year) represent a high-risk group with accelerated disease progression.Bronchiectasis has become a major health concern due to its increasing prevalence and associated healthcare costs (5). The disease can be caused by many different etiologies, which may be causative, synergistic, or coincidental, depending on the manner in which they interact and it is clinically characterized by a variety of symptoms, including cough, sputum production and airway infection, and can often present with recurrent exacerbations (6). An exacerbation is generally defined as a sustained clinical deterioration characterized by an increase in symptoms, which may include increased cough, increased sputum volume or change in consistency, increased sputum purulence (color change), increased breathlessness and/or reduced exercise tolerance, increased fatigue and/or malaise, hemoptysis for at least 48 h requiring a change in treatment.
Recurrent exacerbations are related to elevated systemic and airway inflammation, deterioration of lung function and progression of the disease(7). In addition to known etiologies of bronchiectasis, several other diseases may occur at any stage of bronchiectasis and are likely major contributors to increased hospitalizations, healthcare utilization and socioeconomic costs. These include cardiovascular disorders, gastro-oesophageal reflux disease (GORD), psychological illnesses, pulmonary hypertension, cognitive impairment, and lung, oesophageal and hematological malignancies (8-9).
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients at Department of Chest Diseases and Outpatient Chest Clinic, Sohag University Hospitals.
Key inclusion criteria (1 listed)
- adult patients (≥18 years) with non-cystic fibrosis bronchiectasis confirmed by High Resolution Computed Tomography (HRCT).
Key exclusion criteria (5 listed)
- Patients with cystic fibrosis-related bronchiectasis.
- Patients with active pulmonary tuberculosis.
- Patients with chronic debilitating diseases e.g. advanced hepatic or renal diseases.
- Patients with primary autoimmune or malignancy requiring immunosuppressive therapy at the time of the marker measurement.
- Patients refusing participation.
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 |
|---|---|---|
| Inflammatory Markers and Radiological Findings1. Functional assessment: the available functional assessment will be performed. 2. Laboratory: CBC, neutrophil: lymphocyte ratio (NLR), platelet : lymphocyte ratio (PLR), C-reactive protein (CRP), ESR, renal and liver function, serum albumin level. 3. Microbiology: Sputum Gram stain, culture and sensitivity when indicated. 4. Radiology: High Resolution CT chest with lobar assessment and severity scoring (Reiff, Bhalla, BRICS). | Other | – |
Primary outcome
Correlation of the inflammatory markers and radiological findings with exacerbation phenotype.
Time frame: 1/11/2026
1 secondary outcome
Correlation of the inflammatory markers and radiological findings with QoL scores and hospitalizations
Time frame: 1/11/2026
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 27 Mar 2026.
- Background: PubMed 11986413Barker AF. Bronchiectasis. N Engl J Med. 2002 May 2;346(18):1383-93. doi: 10.1056/NEJMra012519. No abstract available.
- Background: PubMed 30049739Polverino E, Dimakou K, Hurst J, Martinez-Garcia MA, Miravitlles M, Paggiaro P, Shteinberg M, Aliberti S, Chalmers JD. The overlap between bronchiectasis and chronic airway diseases: state of the art and future directions. Eur Respir J. 2018 Sep 15;52(3):1800328. doi: 10.1183/13993003.00328-2018. Print 2018 Sep.
- Background: PubMed 24142190Olveira C, Olveira G, Espildora F, Giron RM, Munoz G, Quittner AL, Martinez-Garcia MA. Validation of a Quality of Life Questionnaire for Bronchiectasis: psychometric analyses of the Spanish QOL-B-V3.0. Qual Life Res. 2014 May;23(4):1279-92. doi: 10.1007/s11136-013-0560-0. Epub 2013 Oct 19.
- Background: PubMed 32823681Menendez R, Mendez R, Amara-Elori I, Reyes S, Montull B, Feced L, Alonso R, Amaro R, Alcaraz V, Fernandez-Barat L, Torres A. Systemic Inflammation during and after Bronchiectasis Exacerbations: Impact of Pseudomonas aeruginosa. J Clin Med. 2020 Aug 13;9(8):2631. doi: 10.3390/jcm9082631.
- Background: PubMed 33609487Keir HR, Shoemark A, Dicker AJ, Perea L, Pollock J, Giam YH, Suarez-Cuartin G, Crichton ML, Lonergan M, Oriano M, Cant E, Einarsson GG, Furrie E, Elborn JS, Fong CJ, Finch S, Rogers GB, Blasi F, Sibila O, Aliberti S, Simpson JL, Huang JTJ, Chalmers JD. Neutrophil extracellular traps, disease severity, and antibiotic response in bronchiectasis: an international, observational, multicohort study. Lancet Respir Med. 2021 Aug;9(8):873-884. doi: 10.1016/S2213-2600(20)30504-X. Epub 2021 Feb 17.
- Background: PubMed 31577911El-Gazzar AG, Kamel MH, Elbahnasy OKM, El-Naggar ME. Prognostic value of platelet and neutrophil to lymphocyte ratio in COPD patients. Expert Rev Respir Med. 2020 Jan;14(1):111-116. doi: 10.1080/17476348.2019.1675517. Epub 2019 Oct 13.
- Background: PubMed 26096858Taylan M, Demir M, Kaya H, Selimoglu Sen H, Abakay O, Carkanat AI, Abakay A, Tanrikulu AC, Sezgi C. Alterations of the neutrophil-lymphocyte ratio during the period of stable and acute exacerbation of chronic obstructive pulmonary disease patients. Clin Respir J. 2017 May;11(3):311-317. doi: 10.1111/crj.12336. Epub 2015 Aug 6.
- Background: PubMed 25271081Hu B, Yang XR, Xu Y, Sun YF, Sun C, Guo W, Zhang X, Wang WM, Qiu SJ, Zhou J, Fan J. Systemic immune-inflammation index predicts prognosis of patients after curative resection for hepatocellular carcinoma. Clin Cancer Res. 2014 Dec 1;20(23):6212-22. doi: 10.1158/1078-0432.CCR-14-0442. Epub 2014 Sep 30.
- Background: PubMed 32331706Posadas T, Oscullo G, Zaldivar E, Villa C, Dobarganes Y, Giron R, Olveira C, Maiz L, Garcia-Clemente M, Sibila O, Golpe R, Rodriguez J, Barreiro E, Rodriguez JL, Menendez R, Prados C, de la Rosa D, Martinez-Garcia MA; Spanish Registry of Bronchiectasis Group (RIBRON); SPANISH REGISTRY OF BRONCHIECTASIS GROUP. C-Reactive Protein Concentration in Steady-State Bronchiectasis: Prognostic Value of Future Severe Exacerbations. Data From the Spanish Registry of Bronchiectasis (RIBRON). Arch Bronconeumol (Engl Ed). 2021 Jan;57(1):21-27. doi: 10.1016/j.arbres.2019.12.017. Epub 2020 Apr 21. English, Spanish.
- Background: PubMed 25912205Lee JL, Oh ES, Lee RW, Finucane TE. Serum Albumin and Prealbumin in Calorically Restricted, Nondiseased Individuals: A Systematic Review. Am J Med. 2015 Sep;128(9):1023.e1-22. doi: 10.1016/j.amjmed.2015.03.032. Epub 2015 Apr 23.
- Background: PubMed 26846833Aliberti S, Lonni S, Dore S, McDonnell MJ, Goeminne PC, Dimakou K, Fardon TC, Rutherford R, Pesci A, Restrepo MI, Sotgiu G, Chalmers JD. Clinical phenotypes in adult patients with bronchiectasis. Eur Respir J. 2016 Apr;47(4):1113-22. doi: 10.1183/13993003.01899-2015. Epub 2016 Feb 4.
- Background: PubMed 38884647Chen YF, Hou HH, Chien N, Lu KZ, Chen YY, Hung ZC, Chien JY, Wang HC, Yu CJ. Type 2 Biomarkers and Their Clinical Implications in Bronchiectasis: A Prospective Cohort Study. Lung. 2024 Oct;202(5):695-709. doi: 10.1007/s00408-024-00707-0. Epub 2024 Jun 17.
- Individual participant dataSharing planned: Undecided
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.
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 Correlation of Inflammatory Markers and Radiological Findings in Stable Bronchiectasis Patients, run by Sohag 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 5 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 27 Mar 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation of the inflammatory markers and radiological findings with exacerbation phenotype. (time frame: 1/11/2026). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07495982, which also lists 12 linked publications.
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 27 Mar 2026.