Sjogren's SyndromeNCT04843345
Sjogren's Lung Study
An observational study of Sjogren's Syndrome and Interstitial Lung Disease, run by Stanford University at 1 site in United States.
Trial summary
Lung involvement in Sjögren's syndrome is common and causes reduced quality of life and increased mortality. Sjögren's syndrome-related lung diseases (SS-RLD) are classified and treated as the primary lung diseases they resemble. Whether this approach is optimal has not been evaluated thoroughly. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sjogren's Syndrome, Interstitial Lung Disease, Primary Pulmonary Lymphoma (Disorder)
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2021to 1 Apr 2030
- How long will I take part?
- 5 Years
- 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: The investigators aim to capture a wide range of adult patients with lung disease to better understand the contribution of Sjogren's syndrome to lung disease
Who may be able to join
- Group 1: Interstitial Lung Disease and Other Parenchymal Lung Diseases
- Known or suspected interstitial lung disease regardless of radiographic pattern
- Interstitial lung disease due to alternative autoimmune etiology
- Sarcoidosis
- Organizing pneumonia
- Hypersensitivity pneumonitis absent known or suspected trigger
Show all 18Show fewer
- Primary pulmonary lymphoma
- Other idiopathic pulmonary conditions at discretion of study team
- Group 2: Refractory Airway Symptoms
- Chronic cough despite treatment trials with albuterol, proton-pump inhibitors and anti-histamine and intranasal corticosteroids
- Persistent bronchial hyperreactivity (defined as positive response to methacholine challenge on spirometry or subjective worsening after exposure to airway irritants such as tobacco, pollution, etc) or persistent asthma symptoms despite trial of inhaled corticosteroid and long acting bronchodilator
- Unexplained persistent bronchial wall thickening on CT imaging
- Recurrent or chronic bronchiolitis (including but not limited to chronic bronchiolitis, obliterative bronchiolitis, lymphocytic bronchiolitis, constrictive bronchiolitis associated with bronchiolar destruction, and panbronchiolitis)
- Bronchiectasis
- Lymphocytic alveolitis on bronchoalveolar lavage absent hypersensitivity pneumonitis with known trigger or HIV
- Recurrent bacterial pneumonia (greater than 2 episodes in 1 year, confirmed by focal consolidative opacity on chest imaging and requiring antibiotic therapy)
- Group 3: Other
- •Select patients outside the protocol testing schema who have one of the above lung diseases and are found to have Sjogren's syndrome through the course of their normal clinical care will be invited to participate in the data collection portion of the study for analyzing longitudinal outcomes.
Who cannot join
- Patients with interstitial lung disease due to a known or suspected trigger such as drug-induced (including but not limited to nitrofurantoin, amiodarone, methotrexate and other chemotherapies), inorganic dust exposure (including but not limited to asbestos, silica, hard metals, coal dust) or organic exposure (including but not limited to birds, hay, mold).
- Patients who have taken a muscarinic antagonist or agonists within 7 days of planned testing
- Patients who are unable to consent for themselves
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Cohort Study of Treatment Response in Sjogren's Syndrome-Related Lung Diseases Compared to Primary Idiopathic Lung Diseases
Lung involvement in Sjögren's syndrome is common and causes reduced quality of life and increased mortality. Sjögren's syndrome-related lung diseases (SS-RLD) are classified and treated as the primary lung diseases they resemble. Whether this approach is optimal has not been evaluated thoroughly. A critical gap in knowledge is knowing whether SS-RLDs have a unique clinical course and response to therapy. Given the underlying immune system dysfunction in Sjögren's syndrome, the investigators hypothesize that patients with SS-RLD will be more likely to respond to immunosuppressive therapy than patients with the matching primary lung disease. To address this hypothesis, the investigators will prospectively screen for Sjogren's syndrome in patients presenting to pulmonary clinics and compare the clinical course and response to therapy in Sjogren's syndrome positive and negative patients.
Read the detailed description
Sjögren's syndrome is an autoimmune disease affecting at least 1% of adults characterized by hyperactive lymphocytes that damage exocrine glands leading to dry eyes and dry mouth. Although less well recognized, lung involvement in Sjögren's syndrome is common and causes reduced health-related quality of life and increased mortality. Sjögren's syndrome-related lung diseases are classified and treated as the primary lung diseases they resemble. Whether this approach is optimal has not been evaluated thoroughly.
Despite the potentially life-threatening consequence of Sjögren's syndrome-related lung disease, general medical education still promotes the false idea that Sjögren's syndrome is a nuisance disease. This leads many clinicians to overlook Sjögren's syndrome as a possible cause for respiratory symptoms. Even when Sjögren's syndrome is identified, there is no standard for attribution of the lung disease and little data on how to best treat it.
Only one study has compared interstitial lung disease patients with and without Sjögren's syndrome. Although it was a small retrospective study, it found that patients with usual interstitial pneumonia and Sjögren's syndrome were more likely to achieve stable lung function with immunosuppressive therapy as compared to the idiopathic cohort. This is striking as usual interstitial pneumonia is generally thought to not be responsive to immunosuppressive therapy.
A critical gap in knowledge is knowing whether Sjögren's syndrome-related lung diseases have a unique clinical course and response to therapy. Given the underlying immune system dysfunction in Sjögren's syndrome, the investigators hypothesize that patients with Sjögren's syndrome-related lung disease will be more likely to respond to immunosuppressive therapy than patients with the matching primary lung disease.
- Conditions
- Sjogren's Syndrome, Interstitial Lung Disease, Primary Pulmonary Lymphoma (Disorder), Chronic Bronchiolitis, Bronchiectasis, Lung Diseases
- Medical subject headings
- Sjogren's Syndrome, Lung Diseases, Interstitial, Bronchiectasis, Lung Diseases, Cystic Disease Of Lung, Lymphoid Interstitial Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Reduced Salivary Flow Patients | Patients with lung disease matching inclusion criteria who screen positive for reduced salivary flow | |
| Normal Salivary Flow Patients | Patients with lung disease matching inclusion criteria who screen negative for reduced salivary flow |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in pulmonary function over time
Based on underlying lung disease, standard measures of lung function (FEV1 vs FVC) will be followed
Measured: Change from first test after enrollment to final test across 5-year monitoring period
Secondary outcomes (2)
Annual rate of hospitalizations from respiratory cause
Measured: Over 5-year monitoring period
Percent of participants who die from respiratory cause
Measured: Over 5-year monitoring period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2021
- Study start1 Apr 2021
- Primary completion1 Apr 2028 (estimated)
- Study completion1 Apr 2030 (estimated)
Why it stopped: Indefinite paused for staffing issues
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sjogren's SyndromeStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jason Melehani, Stanford University
- Investigators
- Jason H Melehani, MD, PhD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04843345
- Sponsor's protocol ID
- IRB-59313
- Status last verified
- Oct 2022
- First submitted
- 8 Apr 2021
- Last updated
- 27 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Cohort Study of Treatment Response in Sjogren's Syndrome-Related Lung Diseases Compared to Primary Idiopathic Lung Diseases
- ClinicalTrials.gov ID
- NCT04843345
- Acronym / sponsor ID
- IRB-59313
- Conditions
- Sjogren's Syndrome, Interstitial Lung Disease, Primary Pulmonary Lymphoma (Disorder), Chronic Bronchiolitis, Bronchiectasis, Lung Diseases
- Study type
- Observational
- Recruitment status
- SuspendedReason stopped: Indefinite paused for staffing issues
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 1 Apr 2028 (estimated)
- Study completion
- 1 Apr 2030 (estimated)
- First posted
- 13 Apr 2021 (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.
Lung involvement in Sjögren's syndrome is common and causes reduced quality of life and increased mortality. Sjögren's syndrome-related lung diseases (SS-RLD) are classified and treated as the primary lung diseases they resemble. Whether this approach is optimal has not been evaluated thoroughly. A critical gap in knowledge is knowing whether SS-RLDs have a unique clinical course and response to therapy. Given the underlying immune system dysfunction in Sjögren's syndrome, the investigators hypothesize that patients with SS-RLD will be more likely to respond to immunosuppressive therapy than patients with the matching primary lung disease. To address this hypothesis, the investigators will prospectively screen for Sjogren's syndrome in patients presenting to pulmonary clinics and compare the clinical course and response to therapy in Sjogren's syndrome positive and negative patients.
Detailed description
Sjögren's syndrome is an autoimmune disease affecting at least 1% of adults characterized by hyperactive lymphocytes that damage exocrine glands leading to dry eyes and dry mouth. Although less well recognized, lung involvement in Sjögren's syndrome is common and causes reduced health-related quality of life and increased mortality. Sjögren's syndrome-related lung diseases are classified and treated as the primary lung diseases they resemble. Whether this approach is optimal has not been evaluated thoroughly.
Despite the potentially life-threatening consequence of Sjögren's syndrome-related lung disease, general medical education still promotes the false idea that Sjögren's syndrome is a nuisance disease. This leads many clinicians to overlook Sjögren's syndrome as a possible cause for respiratory symptoms. Even when Sjögren's syndrome is identified, there is no standard for attribution of the lung disease and little data on how to best treat it.
Only one study has compared interstitial lung disease patients with and without Sjögren's syndrome. Although it was a small retrospective study, it found that patients with usual interstitial pneumonia and Sjögren's syndrome were more likely to achieve stable lung function with immunosuppressive therapy as compared to the idiopathic cohort. This is striking as usual interstitial pneumonia is generally thought to not be responsive to immunosuppressive therapy.
A critical gap in knowledge is knowing whether Sjögren's syndrome-related lung diseases have a unique clinical course and response to therapy. Given the underlying immune system dysfunction in Sjögren's syndrome, the investigators hypothesize that patients with Sjögren's syndrome-related lung disease will be more likely to respond to immunosuppressive therapy than patients with the matching primary lung disease.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Reduced Salivary Flow Patients | – | –Patients with lung disease matching inclusion criteria who screen positive for reduced salivary flow |
| Normal Salivary Flow Patients | – | –Patients with lung disease matching inclusion criteria who screen negative for reduced salivary flow |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The investigators aim to capture a wide range of adult patients with lung disease to better understand the contribution of Sjogren's syndrome to lung disease
Key inclusion criteria (18 listed)
- Group 1: Interstitial Lung Disease and Other Parenchymal Lung Diseases
- Known or suspected interstitial lung disease regardless of radiographic pattern
- Interstitial lung disease due to alternative autoimmune etiology
- Sarcoidosis
- Organizing pneumonia
Key exclusion criteria (3 listed)
- Patients with interstitial lung disease due to a known or suspected trigger such as drug-induced (including but not limited to nitrofurantoin, amiodarone, methotrexate and other chemotherapies), inorganic dust exposure (including but not limited to asbestos, silica, hard metals, coal dust) or organic exposure (including but not limited to birds, hay, mold).
- Patients who have taken a muscarinic antagonist or agonists within 7 days of planned testing
- Patients who are unable to consent for themselves
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in pulmonary function over time
Time frame: Change from first test after enrollment to final test across 5-year monitoring period
Based on underlying lung disease, standard measures of lung function (FEV1 vs FVC) will be followed
2 secondary outcomes
Annual rate of hospitalizations from respiratory cause
Time frame: Over 5-year monitoring period
Percent of participants who die from respiratory cause
Time frame: Over 5-year monitoring period
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2022.
- 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.
Jason H Melehani, MD, PhD principal investigator
Stanford University
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 Sjogren's Syndrome and Interstitial Lung Disease, run by Stanford University at 1 site in United States.
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 18 inclusion and 3 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: paused, as of the sponsor's last update on 27 Oct 2022. 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 United States. 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?
Change in pulmonary function over time (time frame: Change from first test after enrollment to final test across 5-year monitoring period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Oct 2022.