NCT07730047

Brief Summary

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.

Trial Health

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Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
140

participants targeted

Target at P50-P75 for all trials

Timeline
6mo left

Started Aug 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress1%
Aug 2026Feb 2027

First Submitted

Initial submission to the registry

July 22, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 28, 2026

Completed
4 days until next milestone

Study Start

First participant enrolled

August 1, 2026

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2027

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2027

Last Updated

July 28, 2026

Status Verified

July 1, 2026

Enrollment Period

5 months

First QC Date

July 22, 2026

Last Update Submit

July 24, 2026

Conditions

Keywords

AsthmaNeutrophil to Lymphocyte RatioEosinophil to Lymphocyte RatioSystemic Immune- Inflammation IndexAsthma Control Test

Outcome Measures

Primary Outcomes (1)

  • Asthma Control Test (ACT) score.

    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 Outcomes (1)

  • Comparison of the accuracy of NLR, ELR, and SII to determine the most reliable biomarker for asthma control assessment.

    Baseline(day 1)

Study Arms (2)

Asthma patients

patients with physician- diagnosed asthma

Other: Complete blood count

Healthy control

Healthy volunteers without asthma

Other: Complete blood count

Interventions

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

Asthma patientsHealthy control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chest Department,Assiut University Hospital

Asyut, Asyut Governorate, 71515, Egypt

Location

MeSH Terms

Conditions

Asthma

Interventions

Blood Cell Count

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

Cell CountCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisHematologic TestsInvestigative TechniquesCell Physiological PhenomenaBlood Physiological PhenomenaCirculatory and Respiratory Physiological Phenomena

Study Officials

  • Shaimaa A Mohammed, MD

    Chest Department,Faculty of Medicine,Assiut University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Shaimaa A Mohammed, MD

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
principal Investigator

Study Record Dates

First Submitted

July 22, 2026

First Posted

July 28, 2026

Study Start

August 1, 2026

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

February 1, 2027

Last Updated

July 28, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Locations