Clinical Trials Logo

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT06087523
Other study ID # OP_1858
Secondary ID
Status Enrolling by invitation
Phase
First received
Last updated
Start date August 15, 2023
Est. completion date January 1, 2026

Study information

Verified date October 2023
Source Odense University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 200
Est. completion date January 1, 2026
Est. primary completion date September 30, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Intervention

Other:
Multidisciplinary discussion
Multidisciplinary discussion: Participants will be diagnosed and categorized in regards of pulmonary disease on basis of medical record, PFT, HRCT, and questionnaires. PFT: Participants will undergo body plethysmography (with diffusion) and six-minute walk test. Analysis of circulating biomarkers: We will store glasses with serum and glasses with plasma and analyse them for circulating biomarker. Questionnaires: Participants will complete Danish versions of three questionnaires. Saint George's Respiratory Questionnaire Interstitial Pulmonary Fibrosis Systemic Lupus Activity Questionnaire Lupus Impact Tracker Review of medical record and clinical investigation with focus on SLE and pulmonary disease. Thoracic and diaphragmatic ultrasound: The participants will undergo a 14 zone protocol, and be evaluated for b-lines and pleural thickening/irregularities. Diaphragm function will be evaluated according to the M-mode method, area method, and for thickening.

Locations

Country Name City State
Denmark Odense University Hospital Odense Region Southern Denmark

Sponsors (5)

Lead Sponsor Collaborator
Odense University Hospital Hospital of South West Jutland, Karolinska University Hospital, Sonderborg Hospital, Vejle Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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.
See also
  Status Clinical Trial Phase
Active, not recruiting NCT03572335 - Systems Biology of Diffusion Impairment in Human Immunodeficiency Virus (HIV)
Recruiting NCT06088485 - The Effect of Bone Mineral Density in Patients With Adult Cystic Fibrosis
Terminated NCT03309358 - A Study of the Safety and Tolerability of Inhaled SNSP113 in Healthy Subjects and Subjects With Stable Cystic Fibrosis Phase 1
Active, not recruiting NCT02504697 - DECAMP-2: Screening of Patients With Early Stage Lung Cancer or at High Risk for Developing Lung Cancer
Completed NCT01443845 - Roflumilast in Chronic Obstructive Pulmonary Disease (COPD) Patients Treated With Fixed Dose Combinations of Long-acting β2-agonist (LABA) and Inhaled Corticosteroid (ICS) Phase 4
Terminated NCT00524095 - Bronchiectasis in Chronic Obstructive Pulmonary Disease (COPD) Patients: Role of Prophylaxis Phase 2
Completed NCT00210249 - Development of an Evaluation Method of Elderly Condition in Patient Receiving Chemotherapy Treatment
Completed NCT00023114 - p450 Mediated Lung Toxicity N/A
Recruiting NCT06056882 - Simultaneous CLE Guided Crybiopsy in Patients With Pulmonary Nodules
Completed NCT03994848 - Incentive Spirometry Prehabilitation Study N/A
Completed NCT00366509 - Role of Helicobacter Pylori and Its Toxins in Lung and Digestive System Diseases
Withdrawn NCT05100160 - Gabapentin for the Reduction of Opiate Use Following Pulmonary Resection (GROUP Trial) Phase 3
Completed NCT03229473 - Fall Risk Assessment in COPD
Recruiting NCT04767074 - A Non-pharmacological Cough Control Therapy N/A
Not yet recruiting NCT03899298 - Safety and Clinical Outcomes With Amniotic and Umbilical Cord Tissue Therapy for Numerous Medical Conditions Phase 1
Completed NCT04996693 - On Dose Efficiency of Modern CT-scanners in Chest Scans N/A
Recruiting NCT04996173 - Cryospray Therapy Versus Standard of Care for Benign Airway Stenosis (CryoStasis) N/A
Completed NCT04601545 - The Virtual Reality Therapy as a Pulmonary Rehabilitation Supporting Method N/A
Recruiting NCT03937583 - Screening for Cancer in Patients With Unprovoked VTE Phase 4
Recruiting NCT02862418 - Imaging of Lungs With a New Type of Magnetic Resonance Imaging (MRI) Called UTE (Ultrashort Echo Time)