nCD64 vs. Neutrophil/Lymphocyte Ratio for Predicting In-hospital Outcome in AE-COPD
Neutrophil CD64 Versus Neutrophil/Lymphocyte Ratio (NLR) as Markers Predicting In-hospital Outcome in Acute Exacerbation of COPD
1 other identifier
observational
75
1 country
1
Brief Summary
Neutrophil CD64 versus Neutrophil/Lymphocyte ratio (NLR) as markers predicting in-hospital outcome in acute exacerbation of COPD
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Mar 2016
1 active site
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 Start
First participant enrolled
March 11, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
April 20, 2017
CompletedFirst Submitted
Initial submission to the registry
April 22, 2017
CompletedFirst Posted
Study publicly available on registry
May 10, 2017
CompletedMay 11, 2017
May 1, 2017
12 months
April 22, 2017
May 9, 2017
Conditions
Outcome Measures
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
3 months
Secondary Outcomes (1)
Can nCD64 and NLR as markers be used as predictors for short term hospital outcome
3 months
Study Arms (2)
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.
control
healthy sex and age matched group
Interventions
Neutrophil/ lymphocyte ratio
Eligibility Criteria
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.
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
AssiutU
Asyut, 71111, Egypt
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prof. Dr. Aliae AR Mohamed-Hussein, Professor of Pulmonology
Study Record Dates
First Submitted
April 22, 2017
First Posted
May 10, 2017
Study Start
March 11, 2016
Primary Completion
March 1, 2017
Study Completion
April 20, 2017
Last Updated
May 11, 2017
Record last verified: 2017-05
Data Sharing
- IPD Sharing
- Will not share