Respiratory Tract DiseasesNCT02093936
Lymphocytes Cut Off Values of Induced Sputum Samples in Healthy and Non-healthy Patients- A Cross Sectional Study
An observational study of Respiratory Tract Diseases and Occupational Diseases, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Respiratory Tract Diseases, Occupational Diseases, Disorders of Environmental Origin
- How many people
- 1,000 participants
- Where
- 1 siteIsrael
- Study dates
- Jan 2005to Jan 2013
- How long will I take part?
- 10 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- patients suffering from pulmonary symptoms or diseases
- patients with occupational or environmental exposure
Who cannot join
- indefinite spirometry tests
Trial locations and contacts
1 site in 1 country.
About this 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.
Read more
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.
- Keywords
- airway inflammation, induced sputum, normal values, lymphocyte, eosinophil, neutrophil
- Medical subject headings
- Respiratory Tract Diseases, Occupational Diseases, Disorders of Environmental Origin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Healthy non exposed | Healthy patients with no pulmonary symptoms that were not exposed to occupational or environmental exposure | |
| Healthy exposed | Healthy patients with no pulmonary symptoms that were exposed to occupational or environmental exposure | |
| Non-healthy exposed | Patients with pulmonary symptoms or diseases that were exposed to occupational or environmental exposure | |
| Non-healthy non-exposed | Patients with pulmonary symptoms or diseases that were not exposed to occupational or environmental exposure |
What is being measured
The primary outcome is the main question the study is designed to answer.
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%).
Measured: 1 year
Secondary outcomes (4)
Eosinophil percentage out of all White blood cells in Sputum sample
Measured: Up to 1 day from sputum induction
Neutrophil percentage out of all White blood cells in Sputum sample
Measured: Up to 1 day from sputum induction
T cell Lymphocyte cluster of differentiation 4 / cluster of differentiation 8 (CD4/CD8) ratio in Sputum sample
Measured: Up to 1 day from sputum induction
Lymphocyte percentage out of all White blood cells in Sputum sample
Measured: Up to 1 day from sputum induction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2014 (estimated)
- Study startJan 2005
- Primary completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Respiratory Tract DiseasesStudies of the same condition, open and under way.
- More trials run by Tel-Aviv Sourasky Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Cross-sectional
- Enrolment
- 1,000 participants (actual)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Shmuel Kivity, Professor, Principal investigator, Tel-Aviv Sourasky Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02093936
- Sponsor's protocol ID
- TASMC-14-SK-0629-13-CTIL
- Status last verified
- Mar 2014
- First submitted
- 17 Mar 2014
- Last updated
- 21 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 17906085Fireman 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.
PubMed 10710066Fireman 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.
PubMed 10603633Fireman 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.
PubMed 16890149Pin 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.
PubMed 1539140
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lymphocytes Cut Off Values of Induced Sputum Samples in Healthy and Non-healthy Patients- A Cross Sectional Study
- ClinicalTrials.gov ID
- NCT02093936
- Acronym / sponsor ID
- TASMC-14-SK-0629-13-CTIL
- Keywords
- airway inflammation, induced sputum, normal values, lymphocyte, eosinophil, neutrophil
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Study start
- Jan 2005
- Primary completion
- Jan 2013 (actual)
- First posted
- 21 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Time perspective
- Cross-sectional
- Target follow-up
- 10 Years
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Healthy non exposed | – | –Healthy patients with no pulmonary symptoms that were not exposed to occupational or environmental exposure |
| Healthy exposed | – | –Healthy patients with no pulmonary symptoms that were exposed to occupational or environmental exposure |
| Non-healthy exposed | – | –Patients with pulmonary symptoms or diseases that were exposed to occupational or environmental exposure |
| Non-healthy non-exposed | – | –Patients with pulmonary symptoms or diseases that were not exposed to occupational or environmental exposure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- patients suffering from pulmonary symptoms or diseases
- patients with occupational or environmental exposure
Key exclusion criteria (1 listed)
- indefinite spirometry tests
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Healthy patients vs. non-healthy patients
Time frame: 1 year
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%).
4 secondary outcomes
Eosinophil percentage out of all White blood cells in Sputum sample
Time frame: Up to 1 day from sputum induction
Neutrophil percentage out of all White blood cells in Sputum sample
Time frame: Up to 1 day from sputum induction
T cell Lymphocyte cluster of differentiation 4 / cluster of differentiation 8 (CD4/CD8) ratio in Sputum sample
Time frame: Up to 1 day from sputum induction
Lymphocyte percentage out of all White blood cells in Sputum sample
Time frame: Up to 1 day from sputum induction
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2014.
- Background: PubMed 17906085Balbi 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.
- Background: PubMed 10710066Fireman 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.
- Background: PubMed 10603633Fireman 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.
- Background: PubMed 16890149Fireman 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.
- Background: PubMed 1539140Pin 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shmuel Kivity, Professor principal investigator
Tel-Aviv Sourasky Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Respiratory Tract Diseases and Occupational Diseases, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Healthy patients vs. non-healthy patients (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02093936, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2014.