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NCT Number: NCT07730047

NLR, ELR and SII Index as Biomarkers of Asthma Control

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Chest Department,Assiut University Hospital

Asyut, Asyut Governorate, 71515, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

complete blood count

Other

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

Primary outcomes

  1. Asthma Control Test (ACT) score.

    Time frame: Baseline (day 1)

    Asthma control will be assessed using the Asthma Control Test (ACT; score range 5-25 points) at baseline. The ACT score will be analyzed for its correlation with neutrophil-to-lymphocyte ratio (NLR), eosinophil-to-lymphocyte ratio (ELR), and systemic immune-inflammation index (SII).

Secondary outcomes

  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)

    To compare the diagnostic performance of NLR, ELR, and SII in distinguishing controlled from uncontrolled asthma and to identify the biomarker with the highest predictive accuracy.

Study contacts

Contact information is provided by the study sponsor or research team.

Shaimaa A Mohammed, MD

CONTACT

[email protected]

00201016599093

Sponsors and collaborators

Lead sponsor

Shaimaa Ali Mohammed

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jul 28, 2026
Registry last updated
Jul 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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