Correlation of Inflammatory Markers and Radiological Findings in Stable Bronchiectasis Patients With Exacerbation Phenotype

NCT07495982 | Recruiting

• 1 other identifier: Soh-Med-26-2-13MS
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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). 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

Outcome Measures

Primary Outcomes (1)

• Correlation of the inflammatory markers and radiological findings with exacerbation phenotype.

  1/11/2026

Secondary Outcomes (1)

• Correlation of the inflammatory markers and radiological findings with QoL scores and hospitalizations

  1/11/2026

Interventions

Inflammatory Markers and Radiological Findings OTHER

1. 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).

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients at Department of Chest Diseases and Outpatient Chest Clinic, Sohag University Hospitals.

You may qualify if:

• adult patients (≥18 years) with non-cystic fibrosis bronchiectasis confirmed by High Resolution Computed Tomography (HRCT).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sohag University: lead

Study Sites (1)

Faculty of medicine

Sohag, 82515, Egypt

RECRUITING

Related Publications (12)

• Barker AF. Bronchiectasis. N Engl J Med. 2002 May 2;346(18):1383-93. doi: 10.1056/NEJMra012519. No abstract available.

  PMID: 11986413 BACKGROUND

• 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.

  PMID: 30049739 BACKGROUND

• 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.

  PMID: 24142190 BACKGROUND

• 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.

  PMID: 32823681 BACKGROUND

• 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.

  PMID: 33609487 BACKGROUND

• 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.

  PMID: 31577911 BACKGROUND

• 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.

  PMID: 26096858 BACKGROUND

• 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.

  PMID: 25271081 BACKGROUND

• 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.

  PMID: 32331706 BACKGROUND

• 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.

  PMID: 25912205 BACKGROUND

• 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.

  PMID: 26846833 BACKGROUND

• 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.

  PMID: 38884647 BACKGROUND

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident of Chest Diseases

Study Record Dates

• First Submitted: March 22, 2026
• First Posted: March 27, 2026
• Study Start: November 1, 2025
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: March 27, 2026

Record last verified: 2026-03

Locations

EG (1)