Lupus Erythematosus, SystemicNCT06087523
Pulmonary Disease Among Patients With Systemic Lupus Erythematosus
An observational study of Lupus Erythematosus, Systemic and Pulmonary Disease, run by Odense University Hospital at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lupus Erythematosus, Systemic, Pulmonary Disease
- What is being tested?
- Multidisciplinary discussion
- How many people
- 200 participants
- Where
- 1 siteDenmark
- Study dates
- 15 Aug 2023to 1 Jan 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients with Systemic Lupus Erythematosus, in Region Southern Denmark (approximately 300 individuals)
Who may be able to join
- 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
Who cannot join
- Participants not having their native lungs
- Not participating in visit day, without a valid reason.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Odense University Hospital
Odense, Region Southern Denmark, DK 5000
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Lupus Erythematosus, Systemic, Pulmonary Disease
- Being tested
- Multidisciplinary discussion
- Keywords
- Lupus Erythematosus, Systemic, Pulmonary Disease, Ultrasonography, Autoantibodies, Patient Reported Outcome Measures, Respiratory Function Tests, Tomography, Spiral Computed
- Medical subject headings
- Lupus Erythematosus, Systemic, Lung Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multidisciplinary discussionOther
Also called Thoracic and diaphragmatic ultrasound, High resolution CT scan of thorax (HRCT), Pulmonary function testing (PFT), Analysis of circulating biomarkers
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: From visit date to diagnose is noted, up to six weeks
Secondary outcomes (1)
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.
Measured: Thoracic ultrasound, diaphragmatic ultrasound, clinical investigations of patients, PFT, HRCT and PROMs are noted with a month after the visit.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2023
- Study start15 Aug 2023
- Primary completion30 Sep 2024 (estimated)
- Study completion1 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lupus Erythematosus, SystemicStudies of the same condition, open and under way.
- More trials run by Odense University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Odense University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Karolinska University Hospital, Esbjerg Hospital - University Hospital of Southern Denmark, Vejle Hospital, Sonderborg Hospital
- Responsible party
- Principal investigator, Anne Voss, Odense University Hospital
- Investigators
- Anne Voss, MD, PhD, Study chair, Odense University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06087523
- Sponsor's protocol ID
- OP_1858
- Status last verified
- Oct 2023
- First submitted
- 8 Sep 2023
- Last updated
- 17 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Langkilde HZ, Romhild Davidsen J, Harders S, Luef S, Kay SD, Lottenburger T, Chrysidis S, Schreiber K, Svenungsson E, Flojborg S, Christensen R, Voss A. Pulmonary diseases in SLE: a population-based cross-sectional study. Lupus Sci Med. 2026 Mar 31;13(1):e001895. doi: 10.1136/lupus-2025-001895.
PubMed 41916742
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Pulmonary Diseases Among Patients With Systemic Lupus Erythematosus, a Population-Based Cross-Sectional Study
- ClinicalTrials.gov ID
- NCT06087523
- Acronym / sponsor ID
- OP_1858
- Conditions
- Lupus Erythematosus, Systemic, Pulmonary Disease
- Keywords
- Lupus Erythematosus, Systemic, Pulmonary Disease, Ultrasonography, Autoantibodies, Patient Reported Outcome Measures, Respiratory Function Tests, Tomography, Spiral Computed
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Odense University HospitalUniversity, hospital or other
- Collaborators
- Karolinska University Hospital, Esbjerg Hospital - University Hospital of Southern Denmark, Vejle Hospital, Sonderborg Hospital
- Study start
- 15 Aug 2023 (actual)
- Primary completion
- 30 Sep 2024 (estimated)
- Study completion
- 1 Jan 2026 (estimated)
- First posted
- 17 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients with Systemic Lupus Erythematosus, in Region Southern Denmark (approximately 300 individuals)
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- Participants not having their native lungs
- Not participating in visit day, without a valid reason.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multidisciplinary discussionAlso: Thoracic and diaphragmatic ultrasound, High resolution CT scan of thorax (HRCT), Pulmonary function testing (PFT), Analysis of circulating biomarkersMultidisciplinary 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. | Other | – |
Primary outcome
Diagnosis of pulmonary diseases
Time frame: From visit date to diagnose is noted, up to six weeks
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)
1 secondary outcome
Ability of alternative diagnostic tools for diagnosis of pulmonary disease in patients with SLE as compared to gold standard
Time frame: Thoracic ultrasound, diaphragmatic ultrasound, clinical investigations of patients, PFT, HRCT and PROMs are noted with a month after the visit.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2023.
- Derived from this study: PubMed 41916742Langkilde HZ, Romhild Davidsen J, Harders S, Luef S, Kay SD, Lottenburger T, Chrysidis S, Schreiber K, Svenungsson E, Flojborg S, Christensen R, Voss A. Pulmonary diseases in SLE: a population-based cross-sectional study. Lupus Sci Med. 2026 Mar 31;13(1):e001895. doi: 10.1136/lupus-2025-001895.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anne Voss, MD, PhD study chair
Odense University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lupus Erythematosus, Systemic and Pulmonary Disease, run by Odense University Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnosis of pulmonary diseases (time frame: From visit date to diagnose is noted, up to six weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06087523, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2023.