Chronic Obstructive Pulmonary Disease ExacerbationNCT07125352
Neutrophil to Lymphocyte Ratio in Acute Exacerbation of Chronic Obstructive Pulmonary Disease
An observational study of Chronic Obstructive Pulmonary Disease Exacerbation, run by Ain Shams University at 1 site in Egypt.
Trial summary
Chronic obstructive pulmonary disease (COPD) stands as one of the leading causes of mortality worldwide. Acute exacerbations of COPD (AECOPD) lead to rapid respiratory function decline and worsened disease status. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease Exacerbation
- What is being tested?
- neutrophil lymphocyte ratio in COPD patients
- How many people
- 190 participants
- Where
- 1 siteEgypt
- Study dates
- 20 May 2025to Mar 2026
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Patients aged 18 and above Patients who will be admitted at Chest department, Ain-Shams University Hospitals diagnosed with AECOPD based on the global initiative for chronic obstructive lung disease 2024 criteria
Who may be able to join
- Patients aged 18 and above, Patients who will be admitted at the Chest department, Ain-Shams University Hospitals, diagnosed with AECOPD based on the Global Initiative for Chronic Obstructive Lung Disease 2024 criteria
Who cannot join
- Patients who refused treatment.
- COPD patients with Malignancy, hematological disorders
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
mona A alhady, MD contact
Egypt1 site, 1 recruiting
- Recruiting
Ain Shams University
Cairo, Abbasyea, 02
Fatma S Ebeid, 01095569596, dr.fatm_ebeid@yahoo.com
About this study
Official title: Neutrophil to Lymphocyte Ratio in Acute Exacerbation of Chronic Obstructive Pulmonary Disease: A Marker of Severity and Prognosis
Chronic obstructive pulmonary disease (COPD) stands as one of the leading causes of mortality worldwide. Acute exacerbations of COPD (AECOPD) lead to rapid respiratory function decline and worsened disease status. Despite recent studies, the ability of the neutrophil-to-lymphocyte ratio (NLR) to predict outcomes in patients with COPD remains controversial. It remains controversial whether NLR can predict clinical outcomes in hospitalized patients with AECOPD. Therefore, this study was conducted to investigate the predictive value of NLR for severity, adverse outcomes in hospitalized patients with AECOPD, and predicting treatment response in patients with AECOPD
Read the detailed description
Chronic obstructive pulmonary disease (COPD) stands as one of the leading causes of mortality worldwide, posing an increasing economic burden. Acute exacerbations of COPD (AECOPD) are defined as acute deterioration of respiratory symptoms requiring additional treatment, leading to rapid respiratory function decline, diminished quality of life, and worsened disease status. Neutrophils are the most common type of white blood cells (WBC) and participate in multiple inflammatory and immune processes through phagocytosis and cytokine release. Lymphocytes play a crucial role as coordinators of the inflammatory and immune processes in various physiological mechanisms. The neutrophil-to-lymphocyte ratio (NLR) is calculated by dividing the number of neutrophils by the number of lymphocytes in the peripheral blood test, reflecting an increase in neutrophils and a secondary decrease in lymphocyte count during the inflammatory response. The NLR is considered a biological marker reflecting the inflammatory condition and is increasingly recognized in various disorders such as pneumonia, malignant, coronary artery disease, or hematological disorders.
- Being tested
- neutrophil lymphocyte ratio in COPD patients
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
neutrophil lymphocyte ratio in COPD patientsOther
Neutrophil lymphocyte ratio in determining severity and prognosis in exacerbation of COPD patients
What is being measured
The primary outcome is the main question the study is designed to answer.
The ratio of neutrophils to lymphocytes in (%) in the CBC
investigate the relation between this % ratio and severity of symptoms and adverse hospitalization outcomes in hospitalized patients with AECOPD
Measured: baseline
Secondary outcomes (1)
The ratio of neutrophils to lymphocytes in (%) in the CBC
- investigate the relation between this % ratio and spirometric indices (FEV1, FVC) as percent predicted in hospitalized patients with AECOPD in their follow up
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2025
- Study start20 May 2025
- Primary completionDec 2025 (estimated)
- Study completionMar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary Disease ExacerbationStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 190 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, hieba gamal ezz-elragal awad, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07125352
- Sponsor's protocol ID
- FMASU R123/2025
- Status last verified
- Aug 2025
- First submitted
- 5 Aug 2025
- Last updated
- 15 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neutrophil to Lymphocyte Ratio in Acute Exacerbation of Chronic Obstructive Pulmonary Disease: A Marker of Severity and Prognosis
- ClinicalTrials.gov ID
- NCT07125352
- Acronym / sponsor ID
- FMASU R123/2025
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 190 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 20 May 2025 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Mar 2026 (estimated)
- First posted
- 15 Aug 2025 (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.
Chronic obstructive pulmonary disease (COPD) stands as one of the leading causes of mortality worldwide. Acute exacerbations of COPD (AECOPD) lead to rapid respiratory function decline and worsened disease status. Despite recent studies, the ability of the neutrophil-to-lymphocyte ratio (NLR) to predict outcomes in patients with COPD remains controversial. It remains controversial whether NLR can predict clinical outcomes in hospitalized patients with AECOPD. Therefore, this study was conducted to investigate the predictive value of NLR for severity, adverse outcomes in hospitalized patients with AECOPD, and predicting treatment response in patients with AECOPD
Detailed description
Chronic obstructive pulmonary disease (COPD) stands as one of the leading causes of mortality worldwide, posing an increasing economic burden. Acute exacerbations of COPD (AECOPD) are defined as acute deterioration of respiratory symptoms requiring additional treatment, leading to rapid respiratory function decline, diminished quality of life, and worsened disease status. Neutrophils are the most common type of white blood cells (WBC) and participate in multiple inflammatory and immune processes through phagocytosis and cytokine release. Lymphocytes play a crucial role as coordinators of the inflammatory and immune processes in various physiological mechanisms. The neutrophil-to-lymphocyte ratio (NLR) is calculated by dividing the number of neutrophils by the number of lymphocytes in the peripheral blood test, reflecting an increase in neutrophils and a secondary decrease in lymphocyte count during the inflammatory response. The NLR is considered a biological marker reflecting the inflammatory condition and is increasingly recognized in various disorders such as pneumonia, malignant, coronary artery disease, or hematological disorders.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients aged 18 and above Patients who will be admitted at Chest department, Ain-Shams University Hospitals diagnosed with AECOPD based on the global initiative for chronic obstructive lung disease 2024 criteria
Key inclusion criteria (1 listed)
- Patients aged 18 and above, Patients who will be admitted at the Chest department, Ain-Shams University Hospitals, diagnosed with AECOPD based on the Global Initiative for Chronic Obstructive Lung Disease 2024 criteria
Key exclusion criteria (2 listed)
- Patients who refused treatment.
- COPD patients with Malignancy, hematological disorders
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 |
|---|---|---|
| neutrophil lymphocyte ratio in COPD patientsNeutrophil lymphocyte ratio in determining severity and prognosis in exacerbation of COPD patients | Other | – |
Primary outcome
The ratio of neutrophils to lymphocytes in (%) in the CBC
Time frame: baseline
investigate the relation between this % ratio and severity of symptoms and adverse hospitalization outcomes in hospitalized patients with AECOPD
1 secondary outcome
The ratio of neutrophils to lymphocytes in (%) in the CBC
Time frame: 3 months
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 15 Aug 2025.
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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.
mona A alhady, MD contact
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 Chronic Obstructive Pulmonary Disease Exacerbation, run by Ain Shams University 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 1 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 15 Aug 2025. 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 Hieba G Ezzelregal, MD (01002041611, hiebagamal24@med.asu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The ratio of neutrophils to lymphocytes in (%) in the CBC (time frame: baseline). 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 15 Aug 2025.