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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00490048
Other study ID # ISUC.CTIL
Secondary ID
Status Completed
Phase N/A
First received June 21, 2007
Last updated June 21, 2007
Start date June 2007
Est. completion date June 2007

Study information

Verified date June 2007
Source Hillel Yaffe Medical Center
Contact n/a
Is FDA regulated No
Health authority Israel: Ministry of Health
Study type Interventional

Clinical Trial Summary

Ulcerative colitis is a systemic disease we assume that extra intestinal involvement as we describein our study( Fireman Z, Osipov A, Kivity S, Kopelman Y, Sternberg A Fireman E: Assessment of pulmonary involvement in Crohn’s disease by induced sputum. Am J Gastroenterol 2000;95(30):730-734. )


Description:

Twenty Ulcerative colitis patients and 20 control subjects (all nonsmokers) without respiratory symptoms will be tested. The induce sputum by 20' inhalation of 3.5% saline using ultrasonic nebulizer. Samples will studied by differential counts of 200 cells on cytopreps stained by Giemsa. T-lymphocyte subset analyses were done by FACS using three monoclonal antibodies: CD3 = total T cells, CD4 = T helper cells, and CD8 = T suppressor-cytotoxic cells. CD4/CD8 >2.5 was considered abnormal.


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date June 2007
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria:

- All the ulceratvive colitis patients without lung involvmentage 18-75 years of age

Exclusion Criteria:

- Pregnant women

- Non cooperative patients

- Smoker

- Lung disease

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Screening


Related Conditions & MeSH terms


Intervention

Procedure:
Induced sputum (inhalation of 3.5% saline)


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Hillel Yaffe Medical Center

References & Publications (1)

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

Outcome

Type Measure Description Time frame Safety issue
Primary lung involvment in Ulcerative colitis patients
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