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

NCT ID: NCT02093936

Last Updated: 2014-03-21

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 1000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2005-01-31

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.

Conditions

Respiratory Tract Diseases; Occupational Diseases; Disorders of Environmental Origin

Study Design

• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Healthy non exposed

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

No interventions assigned to this group

Healthy exposed

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

No interventions assigned to this group

Non-healthy exposed

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

No interventions assigned to this group

Non-healthy non-exposed

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

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• indefinite spirometry tests

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Tel-Aviv Sourasky Medical Center

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Shmuel Kivity, Professor

Role: PRINCIPAL_INVESTIGATOR

Tel-Aviv Sourasky Medical Center

Locations

Tel Aviv Sourasky medical center

Tel Aviv, Israel, Israel

Countries

Israel

References

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.

Reference Type: BACKGROUND

PMID: 17906085 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 10710066 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 10603633 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 16890149 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 1539140 (View on PubMed)

Other Identifiers

TASMC-14-SK-0629-13-CTIL

Identifier Type: -

Identifier Source: org_study_id