Asthma ControlNCT07730047
NLR, ELR and SII Index as Biomarkers of Asthma Control
An observational study of Asthma Control, run by Shaimaa Ali Mohammed at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Asthma Control
- What is being tested?
- Complete blood count
- How many people
- 140 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2026to 1 Feb 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Chest Department,Assiut University Hospital
Asyut, Asyut Governorate, 71515
About this study
Official title: 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.
Read the 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.
- Conditions
- Asthma Control
- Being tested
- Complete blood count
- Keywords
- Asthma, Neutrophil to Lymphocyte Ratio, Eosinophil to Lymphocyte Ratio, Systemic Immune- Inflammation Index, Asthma Control Test
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Complete blood countOther
Venous blood samples will be collected for CBC including neutrophil, lymphocyte, eosinophil, and platelet counts. NLR, ELR, and SII will be calculated
| Study group | Role | What they receive |
|---|---|---|
| Asthma patients | patients with physician- diagnosed asthma Receives: Other: Complete blood count | |
| Healthy control | Healthy volunteers without asthma Receives: Other: Complete blood count |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
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.
Measured: Baseline(day 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2026
- Study start1 Aug 2026 (estimated)
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Asthma ControlStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shaimaa Ali Mohammed
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Shaimaa Ali Mohammed, Assiut University
- Investigators
- Shaimaa A Mohammed, MD, Principal investigator, Chest Department,Faculty of Medicine,Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07730047
- Sponsor's protocol ID
- 04-2026-300933
- Status last verified
- Jul 2026
- First submitted
- 22 Jul 2026
- Last updated
- 28 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neutrophil-to-Lymphocyte Ratio (NLR), Eosinophil-to-Lymphocyte Ratio (ELR), and Systemic Immune-Inflammation (SII) Index as Biomarkers of Asthma Control
- ClinicalTrials.gov ID
- NCT07730047
- Acronym / sponsor ID
- 04-2026-300933
- Conditions
- Asthma Control
- Keywords
- Asthma, Neutrophil to Lymphocyte Ratio, Eosinophil to Lymphocyte Ratio, Systemic Immune- Inflammation Index, Asthma Control Test
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Shaimaa Ali MohammedUniversity, hospital or other
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Feb 2027 (estimated)
- First posted
- 28 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Asthma patients | – | Other: Complete blood countpatients with physician- diagnosed asthma |
| Healthy control | – | Other: Complete blood countHealthy volunteers without asthma |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Complete blood countVenous blood samples will be collected for CBC including neutrophil, lymphocyte, eosinophil, and platelet counts. NLR, ELR, and SII will be calculated | Other | Asthma patients, Healthy control |
Primary outcome
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).
1 secondary outcome
Comparison of the accuracy of NLR, ELR, and SII to determine the most reliable biomarker for asthma control assessment.
Time frame: Baseline(day 1)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Shaimaa A Mohammed, MD principal investigator
Chest Department,Faculty of Medicine,Assiut University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma Control, run by Shaimaa Ali Mohammed at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 28 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shaimaa A Mohammed, MD (00201016599093, drshimaalimohammed@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Asthma Control Test (ACT) score. (time frame: Baseline (day 1)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2026.