Lymphocytes Cut Off Values of Induced Sputum Samples in Healthy and Non-healthy Patients- A Cross Sectional Study

Study Overview
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Brief Summary
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Background: Induced sputum (IS) is a noninvasive methodology for evaluating airway inflammation in a large number of pulmonary diseases, i.e, Asthma, Chronic obstructive pulmonary disease and Interstitial Lung Diseases. Several studies have defined normal values and cut-off points for this technique based on cellular components of IS, such as percentages of eosinophils, neutrophils, macrophages and CD4/CD8 ratio of T cell lymphocytes. However, normal values and cut-off points for lymphocyte percentages indicative of pathology have not yet been established or validated. This component of IS has considerable clinical value. Similar to other constituents of IS, it can provide biological insights into the pathogenesis of respiratory disorders and contribute to establishing the diagnosis and guiding treatment management of a variety of airway diseases. The purposes of this study are to define normal values and cut-off points of lymphocytes in IS among individuals with respiratory disorders and healthy volunteers, and to verify the current reference values of the percentage of eosinophils, neutrophils and CD4/CD8 ratio in IS. Methods: A Cross Sectional study which includes a database on up to 900 patients who participated in various studies conducted in the Pulmonary Laboratory of Tel Aviv Sourasky Medical Center between 2005 to 2012 will be established. The study population will include patients diagnosed as having various pulmonary diseases and a group of healthy volunteers who will serve as controls. The cut-off for normal values of lymphocyte, eosinophil and neutrophil percentages and CD4/CD8 ratio in IS will be defined by using ROC curves and evaluating sensitivity and specificity. The comparison of the different values to those in the literature will be done by using the Spearman rank correlation. The results of this study will provide supplementary information on lymphocyte counts in IS for identifying and treating various respiratory diseases.

Official Title
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Lymphocytes Cut Off Values of Induced Sputum Samples in Healthy and Non-healthy Patients- A Cross Sectional Study

Conditions
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Respiratory Tract Diseases, Occupational Diseases, Disorders of Environmental Origin

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients suffering from pulmonary symptoms or diseases patients with occupational or environmental exposure Exclusion Criteria: indefinite spirometry tests

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Healthy non exposed<br>Healthy patients with no pulmonary symptoms that were not exposed to occupational or environmental exposure | |
| Healthy exposed<br>Healthy patients with no pulmonary symptoms that were exposed to occupational or environmental exposure | |
| Non-healthy exposed<br>Patients with pulmonary symptoms or diseases that were exposed to occupational or environmental exposure | |
| Non-healthy non-exposed<br>Patients with pulmonary symptoms or diseases that were not exposed to occupational or environmental exposure | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Healthy patients vs. non-healthy patients | Healthy patients are those who did not suffer from major respiratory symptoms, were not diagnosed with any pulmonary diseases and had normal pulmonary function tests (i.e, FEV1>80%, FEV1/FVC ratio>75%). Non-healthy patients are those who suffered from respiratory symptoms, were diagnosed with a pulmonary disease or had abnormal pulmonary function tests (i.e, FEV1<80%, FEV1/FVC ratio<75%). | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Eosinophil percentage out of all White blood cells in Sputum sample |  | Up to 1 day from sputum induction | 
| Neutrophil percentage out of all White blood cells in Sputum sample |  | Up to 1 day from sputum induction | 
| T cell Lymphocyte cluster of differentiation 4 / cluster of differentiation 8 (CD4/CD8) ratio in Sputum sample |  | Up to 1 day from sputum induction | 
| Lymphocyte percentage out of all White blood cells in Sputum sample |  | Up to 1 day from sputum induction | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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airway inflammation, induced sputum, normal values, lymphocyte, eosinophil, neutrophil