Fibrocytes in Rheumatoid Arthritis, Asthma and Interstitial Lung-disease.

Asthma Clinical Trial

Official title:

Fibrocytes in Rheumatoid Arthritis, Asthma and Interstitial Lung-disease.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02711657
• Other study ID #: S-20150172
• Status: Completed
• Phase: N/A
• First received: March 13, 2016
• Last updated: April 20, 2017
• Start date: January 2016
• Est. completion date: April 2017

Study information

• Verified date: April 2017
• Source: Odense University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To study Fibrocytes in patients with Rheumatoid Arthritis, Interstitial lung disease and severe asthma and healthy controls.

Description:

Objectives: 1) To demonstrate that circulating CD45+ CD34+ CD11b+ cells can express Procollagen 1 and thereby show that these markers can be used to identify circulating fibrocytes. 2) To measure the levels of circulating CD45+, CD34+, CD11b+ cells in patients with RA, Fibrotic ILDs, severe asthma and in healthy controls (HC). 3) To compare the levels with number of peripheral blood mononuclear cells (PBMC) that differentiate to mature fibrocytes in vitro.

Method: The CD45+, CD34+, CD11b+ cells from 4 patients were isolated by cell sorting, and stained for Procollagen. 30 patients (10 of each RA, fibrotic ILDs: IPF or non-specific interstitial pneumonitis (NSIP), severe asthma) and 10 HC were included. Current medication, disease activity, lung function and radiographic data were collected. In 100 µL of lysed blood cells were enumerated by flowcytometry. Further, PBMC were isolated and cultured for 5 days. Coverslips from two wells were stained and mature fibrocytes counted and reported as fibrocytes per 106 PBMC originally added to the well.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: April 2017
• Est. primary completion date: June 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 10 patient with rheumatoid arthritis.

• 10 patient with rheumatoid arthritis and interstitial lung disease

• 10 patients with interstitial lung disease (idiopathic pulmonary fibrosis or nonspecific interstitial pneumonia)

• 10 patients with asthma

• 10 healthy volunteers

Exclusion Criteria:

• Unable to sign written informed consent to participate in the study.

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Asthma
• Interstitial Lung Diseases
• Lung Diseases
• Lung Diseases, Interstitial
• Rheumatoid Arthritis

Intervention

Other:
• Fibrocyte measurement and lung function test.

Locations

Country	Name	City	State
Denmark	Odense University Hospital	Odense

Sponsors (1)

Lead Sponsor	Collaborator
Odense University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measure fibrocytes in peripheral blood.	To measure the levels of circulating CD45+, CD34+, CD11b+ cells (cells/uL) in patients with RA, Fibrotic ILDs, severe asthma and in healthy controls (HC).	Baseline
Secondary	Compare circulating CD45+, CD34+, CD11b+ cells (cells/uL) with number of fibrocytes in cultured cells (fibrocytes/cultured peripheral blood mononuclear cells).	To compare the levels of circulating CD45+, CD34+, CD11b+ cells (cells/uL) with number of peripheral blood mononuclear cells (PBMC) that differentiate to mature fibrocytes in vitro.	Baseline
Secondary	Fibrocytes and lung diffusion capacity.	Is the level of fibrocytes in peripheral blood (cells/uL) correlated signs of interstitial lung disease in a lung function measured by diffusing capacity for carbon monoxide (DLCO) (mmol CO per min per kPa).	Baseline
Secondary	Fibrocytes and rheumatoid arthritis	Is the level of fibrocytes in peripheral blood (cells/uL) correlated to disease activity in rheumatoid arthritis, measured by disease activity score in 28 joints (DAS28).	Baseline