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

Overview

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).

Interventions

• Other Inflammatory Markers and Radiological Findings
  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).

Primary outcome measures

• Correlation of the inflammatory markers and radiological findings with exacerbation phenotype. [Time frame: 1/11/2026]

Secondary outcome measures (1)

• Correlation of the inflammatory markers and radiological findings with QoL scores and hospitalizations [Time frame: 1/11/2026]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

Egypt · 1 center

• Faculty of medicine — Sohag

Publications

• Barker AF. Bronchiectasis. N Engl J Med. 2002 May 2;346(18):1383-93. doi: 10.1056/NEJMra012519. No abstract available. PMID 11986413
• 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
• 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
• 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
• 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. La PMID 33609487
• 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
• 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
• 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

Identifiers

NCT: NCT07495982 · Soh-Med-26-2-13MS

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗