- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07495982
Correlation of Inflammatory Markers and Radiological Findings in Stable Bronchiectasis Patients With Exacerbation Phenotype
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 Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Locations
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Sohag, Egypt, 82515
- Recruiting
- Faculty of medicine
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Contact:
- Mayar Magdy, resident
- Phone Number: +201061041871
- Email: mayar_magdy_post@med.sohag.edu.eg
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- adult patients (≥18 years) with non-cystic fibrosis bronchiectasis confirmed by High Resolution Computed Tomography (HRCT).
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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Correlation of the inflammatory markers and radiological findings with exacerbation phenotype.
Time Frame: 1/11/2026
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1/11/2026
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Correlation of the inflammatory markers and radiological findings with QoL scores and hospitalizations
Time Frame: 1/11/2026
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1/11/2026
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Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Barker AF. Bronchiectasis. N Engl J Med. 2002 May 2;346(18):1383-93. doi: 10.1056/NEJMra012519. No abstract available.
- Aliberti 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.
- Polverino 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.
- Olveira 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.
- Menendez 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.
- Keir 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.
- El-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.
- Taylan 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.
- Hu 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.
- Posadas 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.
- Lee 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.
- Chen 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- Soh-Med-26-2-13MS
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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