Respiratory Tract Diseases Clinical Trial
Official title:
Lymphocytes Cut Off Values of Induced Sputum Samples in Healthy and Non-healthy Patients- A Cross Sectional Study
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.
n/a
Time Perspective: Cross-Sectional
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