Clinical trial NCT02093936: Lymphocytes Cut Off Values of Induced Sputum Samples in Healthy and Non-healthy Patients- A Cross Sectional Study
Official title: Lymphocytes Cut Off Values of Induced Sputum Samples in Healthy and Non-healthy Patients- A Cross Sectional Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Respiratory Tract Diseases
Occupational Diseases
Disorders of Environmental Origin
Keywords: airway inflammation
induced sputum
normal values
lymphocyte
eosinophil
neutrophil
Lead sponsor: Tel-Aviv Sourasky Medical Center
Sponsor class: OTHER_GOV
First posted: 2014-03-21
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: People who were sent to the Pulmonology and Allergy Laboratory in the Tel Aviv sourasky medical center between the years 2005-2012. Some had a certain occupational or environmental exposue, some had pulmunary symptoms or diseases and some had both of the above. They were sent in order to examine through spirometry and induced sputum tests wheather they suffer from a pulmonary pathology.

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* indefinite spirometry tests

Primary outcomes:
measure: Healthy patients vs. non-healthy patients
timeFrame: 1 year
Secondary outcomes:
measure: Eosinophil percentage out of all White blood cells in Sputum sample
timeFrame: Up to 1 day from sputum induction
measure: Neutrophil percentage out of all White blood cells in Sputum sample
timeFrame: Up to 1 day from sputum induction
measure: T cell Lymphocyte cluster of differentiation 4 / cluster of differentiation 8 (CD4/CD8) ratio in Sputum sample
timeFrame: Up to 1 day from sputum induction
measure: Lymphocyte percentage out of all White blood cells in Sputum sample
timeFrame: Up to 1 day from sputum induction
Other outcomes:
Locations:
city: Tel Aviv
country: Israel
facility: Tel Aviv Sourasky medical center
Study officials:
affiliation: Tel-Aviv Sourasky Medical Center
name: Shmuel Kivity, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Balbi B, Pignatti P, Corradi M, Baiardi P, Bianchi L, Brunetti G, Radaeli A, Moscato G, Mutti A, Spanevello A, Malerba M. Bronchoalveolar lavage, sputum and exhaled clinically relevant inflammatory markers: values in healthy adults. Eur Respir J. 2007 Oct;30(4):769-81. doi: 10.1183/09031936.00112306.
citation: Fireman Z, Osipov A, Kivity S, Kopelman Y, Sternberg A, Lazarov E, Fireman E. The use of induced sputum in the assessment of pulmonary involvement in Crohn's disease. Am J Gastroenterol. 2000 Mar;95(3):730-4. doi: 10.1111/j.1572-0241.2000.01843.x.
citation: Fireman E, Topilsky I, Greif J, Lerman Y, Schwarz Y, Man A, Topilsky M. Induced sputum compared to bronchoalveolar lavage for evaluating patients with sarcoidosis and non-granulomatous interstitial lung disease. Respir Med. 1999 Nov;93(11):827-34. doi: 10.1016/s0954-6111(99)90269-x.
citation: Fireman E, Boikaner T, Priel IE. Combined CD4/CD8 ratio in induced sputum and pulmonary function testing for non-invasive identification of sarcoidosis. Transl Res. 2006 Aug;148(2):87-95. doi: 10.1016/j.trsl.2006.03.005.
citation: Pin I, Gibson PG, Kolendowicz R, Girgis-Gabardo A, Denburg JA, Hargreave FE, Dolovich J. Use of induced sputum cell counts to investigate airway inflammation in asthma. Thorax. 1992 Jan;47(1):25-9. doi: 10.1136/thx.47.1.25.