Pulmonary Disease Among Patients With Systemic Lupus Erythematosus

Prevalence of Pulmonary Diseases Among Patients With Systemic Lupus Erythematosus, a Population-Based Cross-Sectional Study

Pulmonary diseases are common among patients with Systemic Lupus Erythematosus (SLE) and associated with a significantly increased morbidity, mortality, and lower self-reported health related quality of life.

The investigators aim to diagnose and categorise SLE patients in regards of pulmonary disease and introduce alternative diagnostic tools.

The investigators will perform a cross-sectional study of a population-based study population of SLE patients. The participants will undergo review of medical record, a clinical assessment, body plethysmography, six-minute walk test, high-resolution computed tomography of the thorax (HRCT), thoracic and diaphragmatic ultrasound, blood sampling with analysis of autoantibodies, and three questionnaires. After the investigations, pulmonary diseases among the participants will be diagnosed at a multidisciplinary discussion by a specialised pulmonologist with contribution from a rheumatologist and a radiologist.

The investigators believe that the study will increase the understanding of pulmonary diseases among SLE patients, which could improve overall disease management. The investigators will introduce new alternative diagnostic tools, that could ease diagnosing pulmonary disease among SLE.

Study Overview

• Status: Enrolling by invitation
• Conditions: Lupus Erythematosus, Systemic; Pulmonary Disease
• Intervention / Treatment: Other: Multidisciplinary discussion

Detailed Description

Background Pulmonary diseases are common among patients with Systemic Lupus Erythematosus (SLE) and cover a variety of manifestations including pleuritis and interstitial lung disease. Pulmonary diseases among SLE patients are associated with an increased morbidity, mortality, and lower self-reported health related quality of life.

Objective The primary objective of the study is to diagnose and categorise a population-based study population of SLE patients in regards of pulmonary diseases. The secondary objective of the study is to introduce alternative diagnostic tools to diagnose pulmonary disease among SLE patients, including thoracic ultrasound and circulating biomarkers.

Methods and Analysis The study will be reported according to the STROBE guidelines. The investigators will perform a cross-sectional study of a population-based study population of SLE patients. The participants will undergo review of medical record, a clinical assessment, body plethysmography, six-minute walk test, HRCT, thoracic and diaphragmatic ultrasound, blood sampling with analysis of autoantibodies, and three questionnaires translated to Danish - Saint George's Respiratory Questionnaire, Systemic Lupus Activity Questionnaire, and Lupus Impact Tracker. After the investigations, pulmonary diseases among the participants will be diagnosed at a multidisciplinary discussion by a specialised pulmonologist with contribution from a rheumatologist and a radiologist. The results will be blinded to the investigators except for Henrik Zachar Langkilde who will have access to results (except for the MDD diagnose) while the investigations are performed, and before the unblinding a statistical analyse plan will be reported. At the second of October 22 participants have had a visit.

Discussion Pulmonary diseases among SLE patients are common and of importance to the patients, but an area not studied as extensively as other disease manifestations. The investigators believe that this study will increase the understanding of pulmonary disease among SLE patients, which could improve overall disease management for the patients. The investigators hope that the alternative diagnostic tools introduced will ease to diagnose pulmonary disease among SLE patients. The study is approved by the Committees on Health Research Ethics and an umbrella organisation under the Danish Data Protection agency. The project, the protocol and the study design are discussed with two SLE patient partners, and the patient partners suggestions have been incorperated in the project.

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

Study Locations

• Denmark
  • Region Southern Denmark
    • Odense, Region Southern Denmark, Denmark, DK 5000
      • Odense University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

All patients with Systemic Lupus Erythematosus, in Region Southern Denmark (approximately 300 individuals)

Description

Inclusion Criteria:

• Followed at a Department of Rheumatology in Region Southern Denmark.
• Living in Region Southern Denmark.
• Diagnosed with Systemic Lupus Erythematosus.
• Fulfil the 2019 European League Against Rheumatism / American College of Rheumatology classification criteria.
• Speak and understand spoken and written Danish

Exclusion Criteria:

• Participants not having their native lungs
• Not participating in visit day, without a valid reason.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diagnosis of pulmonary diseases	Participants will be diagnosed and categorised in regards of pulmonary disease at a multidisciplinary discussion the investigators will note following pulmonary diseases: Pleural disease; Airway disease; ILD; Shrinking lung syndrome; Vascular Disease; Malignancy The diagnosis will be associated to PFT, PROMs, and HRCT. PFT: Body plethysmography; Lung diffusion testing; Six-minutes walk test. HRCT, note presence of; ILD; Airway disease; Pleural disease; Vascular disease PROMs: Saint George's Respiratory Questionnaire Interstitial Pulmonary Fibrosis (SGRQi); Systemic Lupus Activity Questionnaire (SLAQ); Lupus Impact Tracker (LIT)	From visit date to diagnose is noted, up to six weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ability of alternative diagnostic tools for diagnosis of pulmonary disease in patients with SLE as compared to gold standard	Results from thoracic ultrasound, diaphragmatic ultrasound, analysis of circulating biomarkers, clinical investigation of patients, and medical record will be associated to the diagnose from the multidisciplinary discussion, PFT, HRCT, and PROMs, as noted above. Thoracic ultrasound; Number of b-lines; Pleural irregularities Diaphragmatic ultrasound; M-mode method; Area method; Diaphragmatic thickness Circulating biomarkers. The biomarkers are not decided yet. Review of medical record, the investigators will note. - Prior diagnoses, chest immaging, blood and urine samples. Clinical investigation and medical interview, the investigator will score according to: SLEDAI-2k; PGA; SLICC/ACR DI; LLDAS; DORIS and - note changes of the extremities and auscultate the lungs.	Thoracic ultrasound, diaphragmatic ultrasound, clinical investigations of patients, PFT, HRCT and PROMs are noted with a month after the visit.

Collaborators and Investigators

• Sponsor: Odense University Hospital
• Collaborators: Karolinska University Hospital; Vejle Hospital; Sonderborg Hospital; Hospital of South West Jutland
• Investigators: Study Chair: Anne Voss, MD, PhD, Odense University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 15, 2023
• Primary Completion (Estimated): September 30, 2024
• Study Completion (Estimated): January 1, 2026

Study Registration Dates

• First Submitted: September 8, 2023
• First Submitted That Met QC Criteria: October 11, 2023
• First Posted (Actual): October 17, 2023

Study Record Updates

• Last Update Posted (Actual): October 17, 2023
• Last Update Submitted That Met QC Criteria: October 11, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Ultrasonography; Autoantibodies; Patient Reported Outcome Measures; Respiratory Function Tests; Lupus Erythematosus, Systemic; Pulmonary Disease; Tomography, Spiral Computed
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Autoimmune Diseases; Connective Tissue Diseases; Lung Diseases; Lupus Erythematosus, Systemic
• Other Study ID Numbers: OP_1858

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No