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

Tel Aviv Sourasky Medical Center

Status: Completed

Conditions: Respiratory Tract Diseases; Occupational Diseases; Disorders of Environmental Origin

Study type: Observational

Funder types: Other

Identifiers

NCT02093936

TASMC-14-SK-0629-13-CTIL

Details and patient eligibility

About

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.

Enrollment: 1,000 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• patients suffering from pulmonary symptoms or diseases
• patients with occupational or environmental exposure

Exclusion criteria

• indefinite spirometry tests

Trial design

1,000 participants in 4 patient groups

Healthy non exposed

Description:

Healthy patients with no pulmonary symptoms that were not exposed to occupational or environmental exposure

Healthy exposed

Description:

Healthy patients with no pulmonary symptoms that were exposed to occupational or environmental exposure

Non-healthy exposed

Description:

Patients with pulmonary symptoms or diseases that were exposed to occupational or environmental exposure

Non-healthy non-exposed

Description:

Patients with pulmonary symptoms or diseases that were not exposed to occupational or environmental exposure