Interstitial Lung Diseases in Primary Sjogren's Syndrome

Sjogren's Syndrome Clinical Trial

Official title:

Characteristics of Patients With Primary Sjögren's Syndrome Associated Interstitial Lung Disease and Relevant Features of Disease Progression

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04978883
• Other study ID #: 20181236FSKXJ
• Status: Completed
• Start date: January 1, 2016
• Est. completion date: July 31, 2018

Study information

• Verified date: July 2021
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Patients with pSS seen in the Division of Rheumatology, the second affiliated hospital of Zhejiang University, School of Medicine (SAHZU) during January 2016 to July 2018, were retrospectively reviewed. Characteristics were analyzed.

Description:

Patients with pSS were retrospectively reviewed, and pSS-ILD and pSS non-ILD were identified. Clinical data, laboratory parameters, pulmonary high-resolution CT (HRCT), and pulmonary function tests (PFTs) were collected. pSS-ILD patients were further categorized into subgroups according to HRCT patterns or PFTs.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 170
• Est. completion date: July 31, 2018
• Est. primary completion date: July 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• All patients with pSS fulfilled the 2002 revised version of the European criteria proposed by the American-European Consensus Group

• Patient with pSS evaluated with pulmonary HRCT and/or PFTs were included in the pSS-ILD group

Exclusion Criteria:

• patients with hepatitis C infection, past head and neck radiation treatment, sarcoidosis, acquired immunodeficiency syndrome, pre-existing lymphoma, graft-versushost disease, and use of anticholinergic drugs, IgG4-related disease

• Patients with other connective tissue diseases (CTD) or other pulmonary diseases were further excluded, including those with pulmonary arterial hypertension, pulmonary infections, tuberculosis, chronic bronchitis, emphysema, asthma, chronic obstructive pulmonary disease, malignancies, pulmonary lesions related with environmental, occupational or medication exposures, or history of smoking

Related Conditions & MeSH terms

• Lung Diseases
• Lung Diseases, Interstitial
• Sjogren's Syndrome
• Syndrome

Intervention

Other:
• No intervention
No intervention

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	observational study, data analysis to identify the risk factors of pSS-ILD	ILD progressed in 6 months from baseline	6 months from baseline