NLR, ELR and SII Index as Biomarkers of Asthma Control

July 24, 2026 updated by: Shaimaa Ali Mohammed

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 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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

140

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
    • Asyut Governorate
      • Asyut, Asyut Governorate, Egypt, 71515
        • Chest Department,Assiut University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

The study population consists of 140 adults: 70 patients with physician-diagnosed asthma and 70 age- and sex-matched healthy controls recruited from the Chest Department of Assiut University Hospital during the study period

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Asthma patients
patients with physician- diagnosed asthma
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
Healthy control
Healthy volunteers without asthma
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Baseline (day 1)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline(day 1)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shaimaa Ali Mohammed

Investigators

  • Principal Investigator: Shaimaa A Mohammed, MD, Chest Department,Faculty of Medicine,Assiut University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 1, 2026

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

February 1, 2027

Study Registration Dates

First Submitted

July 22, 2026

First Submitted That Met QC Criteria

July 24, 2026

First Posted (Actual)

July 28, 2026

Study Record Updates

Last Update Posted (Actual)

July 28, 2026

Last Update Submitted That Met QC Criteria

July 24, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 04-2026-300933

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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