CClinicalTrials.gg
CompletedNCT03146611Updated May 11, 2017

nCD64 vs. Neutrophil/Lymphocyte Ratio for Predicting In-hospital Outcome in AE-COPD

An observational study in COPD Exacerbation and Copd, sponsored by Assiut University. Completed at 1 site in Egypt. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2017-05-11.

Sponsored by Assiut University · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
75
Ages
18 Years to 75 Years
Sex
All
01

Study summary

Neutrophil CD64 versus Neutrophil/Lymphocyte ratio (NLR) as markers predicting in-hospital outcome in acute exacerbation of COPD

Read the detailed description

Acute exacerbation of COPD is among the most frequent reasons for hospitalisation. Approximately 4% of the general population in the western world is admitted with an acute respiratory disease at least once a year and nearly one fifth of hospital visits is due to acute exacerbation of COPD. Early identifications and management of AE-COPD is an important issue in clinical practice. AE-COPD is accompanied with various worsening respiratory symptoms and deterioration in lung function. Also the frequency and severity of attacks is associated with increased mortality.

During exacerbation, the inflammation in COPD is amplified in comparison with stable periods. The increased level of inflammatory markers is associated with lung function decline. As infection, is the main cause leading to clinical AECOPD, white blood cell counts and ESR are the common markers to show the existence of infection in patients with COPD. Recently, other bio markers are used. Authors have found that the high-affinity Fc receptor-CD64 is expressed by monocytes and only weakly on resting neutrophils. The high-expression of neutrophil CD64 (nCD64) is an early step in the host- immune response to bacterial infection. Studies have shown that the nCD64 might be used as a bio-marker for early-onset sepsis or bacterial infection. However, authors agreed that the value of the nCD64 in COPD prognosis is unknown.

As most of novel bio-markers that identify the severity of acute exacerbation in COPD, are time consuming and expensive, there is a need to use more simple tests. The Neutrophil-lymphocyte ratio is a rapid, easy and cost-effective method derived from routine complete blood count tests in clinical practice. The NLR could be an important marker that assess inflammatory status in patients with COPD and could identify early, acute exacerbation. However, this bio marker has not been widely used in the diagnosis of AECOPD.

The purpose of the present study is: 1- To measure the values of the neutrophil CD64 and NLR in patients with AECOPD and stable COPD, 2- to correlate between nCD64, NLR and the usual routine bio-markers as white blood cell count and erythrocyte sedimentation rate, 3- to investigate the role of nCD64 and NLR as predictors for short term hospital outcome in this group.

02

Conditions studied

  • COPD Exacerbation
  • Copd
03

In context

Pulmonary Disease, Chronic Obstructive

4,131 studies on the registry are indexed under Pulmonary Disease, Chronic Obstructive; 697 are open to participants now.

This study's enrollment of 75 is below the median of 180 across 1,066 observational studies indexed under Pulmonary Disease, Chronic Obstructive.

Browse Pulmonary Disease, Chronic Obstructive studies →

Lead sponsor

Assiut University is the lead sponsor of 4,901 studies on the registry; 2,098 are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Sampling method
Probability sample

Study population

The exacerbation of COPD is defined as the patient being diagnosed with COPD with two or more of the following three symptoms of exacerbations: new or worsening cough, worsened dyspnea, and worsened sputum volume and/or change in its color.

Inclusion criteria

  • patients diagnosed as AECOPD and stable COPD ( random selection by 1:1 cross over). A diagnosis of COPD was made by a clinical history, examination and spirometer (forced expiratory volume in 1st second/forced vital capacity (FEV1/FVC)ratio of \<0.7). The severity of COPD was graded according to the Global Initiative for Chronic Obstructive Lung Disease guidelines.

Exclusion criteria

Exclusion Criteria:

  • history of current respiratory disorders other than COPD, malignancy, systemic auto-immune disorders, recent surgery and severe endocrine, hepatic or renal diseases. Patients with pneumonia, cardiovascular and metabolic diseases
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
75 participants (actual)
Patient registry
No

Groups and cohorts

  • COPD patients

    A diagnosis of COPD was made by a clinical history, examination and spirometer (forced expiratory volume in 1st second/forced vital capacity (FEV1/FVC)ratio of \<0.7). The severity of COPD was graded according to the Global Initiative for Chronic Obstructive Lung Disease guidelines. \[9\] (Stage I, mild COPD: FEV1≥80.0% predicted; Stage II, moderate COPD: FEV1 80-50.0%; Stage III, severe COPD: FEV1 50- 30.0%; Stage IV, very severe COPD: FEV1\< 30.0%). The exacerbation of COPD was defined as the patient being diagnosed with COPD with two or more of the following three symptoms of exacerbations: new or worsening cough, worsened dyspnea, and worsened sputum volume and/or change in its color.

    Diagnostic Test: nCD64 · Diagnostic Test: Neutrophil/Lymphocyte Ratio

  • control

    healthy sex and age matched group

    Diagnostic Test: nCD64 · Diagnostic Test: Neutrophil/Lymphocyte Ratio

Interventions

  • Diagnostic testnCD64

    neutrophil CD64

    Also known as: neutrophil CD64

  • Diagnostic testNeutrophil/Lymphocyte Ratio

    Neutrophil/ lymphocyte ratio

    Also known as: NLR

06

What researchers measure

Primary outcomes

  1. Define the cut off values of the nCD64 and NLR in patients with AE-COPD and stable COPD

    level of nCD64 and NLR that define exacerbation

    Time frame: 3 months

Secondary outcomes

  1. Can nCD64 and NLR as markers be used as predictors for short term hospital outcome

    correlate between level of these markers and hospital outcome

    Time frame: 3 months

07

Study locations

1 site
  • AssiutU
    Assiut, 71111, Egypt
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 11, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03146611
Lead sponsor
Assiut University
Responsible party
Aliae AR Mohamed Hussein (Prof. Dr. Aliae AR Mohamed-Hussein, Professor of Pulmonology, Assiut University) — Principal investigator
First posted
May 10, 2017
Start date
Mar 11, 2016
Primary completion
Mar 1, 2017
Completion
Apr 20, 2017
Last update
May 11, 2017

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2017. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion