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Not yet recruiting NCT07730047

NLR, ELR and SII Index as Biomarkers of Asthma Control

Observational Asthma Control

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Complete blood count.
Who it may be relevant to
Registry conditions: Asthma Control. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Neutrophil-to-Lymphocyte Ratio (NLR), Eosinophil-to-Lymphocyte Ratio (ELR), and Systemic Immune-Inflammation (SII) Index as Biomarkers of Asthma Control

Overview

This is Case control study aims to study Neutrophil-to-Lymphocyte Ratio (NLR), Eosinophil-to-Lymphocyte Ratio (ELR), and Systemic Immune Inflammation (SII) Index as Biomarkers of Asthma Controlin adult patients with bronchial asthma. This study will investigate the association between these inflammatory indices and the level of asthma control to assess their potential value as simple ,readily available and cost -effective biomarkers in clinical practice.

Detailed description

Asthma is a chronic condition, mainly characterized by airway inflammation and hyperresponsiveness. Access to effective treatment allows asthma to be well controlled in most patients. However, a large percentage of patients do not attain adequate asthma control despite optimal therapy. Inadequately controlled patients are at high risk of severe exacerbations and death.

Asthma control test (ACT) is a useful clinical method to quantify asthma control status, and it includes a questionnaire about manifestation, medications use, and personal reporting of asthma control.

Neutrophilic, eosinophilic, paucigranulocytic or mixed granulocytic types are four various endotypes of asthma depending on cell counts of peripheral blood, sputum or bronchoalveolar fluid. Neutrophilic inflammations have been studied to be associated with a poor asthma control. In addition to persistent asthma symptoms and atopy, they have been reported to be associated with the presence of eosinophilic inflammation in asthmatic patients.

The systemic immune-inflammation index (SII) is a novel inflammatory marker, with scarce research reporting on the correlation between SII and asthma and asthma-related events The aim of the work is to study Neutrophil-to-Lymphocyte Ratio (NLR), Eosinophil-to-Lymphocyte Ratio (ELR), and Systemic Immune Inflammation (SII) Index as Biomarkers of Asthma Control This is Case control study that will be carried out at chest department, Assiut University Hospital.

It includes • Adult patients aged \> 18 years.

* Confirmed diagnosis of bronchial asthma according to Global Initiative for Asthma (GINA) guidelines. * Patients who provided informed consent to participate in the study Excluded from the study• Patients with chronic respiratory diseases other than asthma. • Acute respiratory infection within the previous 4 weeks. * Patients with hypertension, diabetes, coronary artery disease, liver and kidney diseases. * Patients with hematological disorders, malignancies, autoimmune diseases, or systemic inflammatory conditions that might affect blood cell counts. * Patients taking systemic steroids, experiencing acute asthma attack (because infection may affect neutrophil level). * Pregnant women. Patients with bronchial asthma will undergo Clinical Assessment Detailed medical history including age, sex, smoking status, duration of asthma, current medications, history of exacerbations, emergency visits, and hospital admissions, followed by complete clinical examination.

Assessment of Asthma Control Asthma control will be assessed using the Asthma Control Test (ACT). ACT was done by asking patients with asthma to complete five questions according to manifestations of asthma, use of relievers, and the effect of the disease on their lives. Scores range from 5 to 25. A total score of 25 is considered as a well control, the level between 20 and 24 is a partial, control whereas a level of 19 and below is a poor control.(9) Laboratory Investigations Venous blood samples will be collected for CBC including neutrophil, lymphocyte, eosinophil, and platelet counts. NLR, ELR, and SII will be calculated.

Interventions

  • Other Complete blood count
    Venous blood samples will be collected for CBC including neutrophil, lymphocyte, eosinophil, and platelet counts. NLR, ELR, and SII will be calculated

Primary outcome measures

  • Asthma Control Test (ACT) score. [Time frame: Baseline (day 1)]
Secondary outcome measures (1)
  • Comparison of the accuracy of NLR, ELR, and SII to determine the most reliable biomarker for asthma control assessment. [Time frame: Baseline(day 1)]

Eligibility criteria

Inclusion criteria

  • Adult patients aged > 18 years.
  • Confirmed diagnosis of bronchial asthma according to Global Initiative for Asthma (GINA) guidelines.
  • Patients who provided informed consent to participate in the study.

Exclusion criteria

  • Patients with chronic respiratory diseases other than asthma.
  • Acute respiratory infection within the previous 4 weeks.
  • Patients with hematological disorders, malignancies, autoimmune diseases, or systemic inflammatory conditions that might affect blood cell counts.
  • Patients taking systemic steroids, experiencing acute asthma attack (because infection may affect neutrophil level).
  • Pregnant women.

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

Healthy volunteers: Yes

Study design

Observational model
Case-control

Study locations

Egypt · 1 center
  • Chest Department,Assiut University Hospital — Asyut

Identifiers

NCT: NCT07730047 · 04-2026-300933

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗