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

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02093936
• Other study ID #: TASMC-14-SK-0629-13-CTIL
• Status: Completed
• Phase: N/A
• First received: March 17, 2014
• Last updated: March 19, 2014
• Start date: January 2005

Study information

• Verified date: March 2014
• Source: Tel-Aviv Sourasky Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ethics CommissionIsrael: Ministry of Health
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1000
• Est. primary completion date: January 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• patients suffering from pulmonary symptoms or diseases

• patients with occupational or environmental exposure

Exclusion Criteria:

• indefinite spirometry tests

Study Design

Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Disorders of Environmental Origin
• Occupational Diseases
• Respiratory Tract Diseases

Locations

Country	Name	City	State
Israel	Tel Aviv Sourasky medical center	Tel Aviv

Sponsors (1)

Lead Sponsor	Collaborator
Tel-Aviv Sourasky Medical Center

Country where clinical trial is conducted

Israel, 

References & Publications (5)

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. Review. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Eosinophil percentage out of all White blood cells in Sputum sample		Up to 1 day from sputum induction	No
Secondary	Neutrophil percentage out of all White blood cells in Sputum sample		Up to 1 day from sputum induction	No
Secondary	T cell Lymphocyte cluster of differentiation 4 / cluster of differentiation 8 (CD4/CD8) ratio in Sputum sample		Up to 1 day from sputum induction	No
Secondary	Lymphocyte percentage out of all White blood cells in Sputum sample		Up to 1 day from sputum induction	No