Clinical trial · Observational
Sjogren's Lung Study
A Prospective Cohort Study of Treatment Response in Sjogren's Syndrome-Related Lung Diseases Compared to Primary Idiopathic Lung Diseases
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Indefinite paused for staffing issues
Summary
Brief summary (as posted)
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.
Conditions
Conditions (8)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bronchiectasis | — | UNRESOLVED | — |
| Chronic Bronchiolitis | — | UNRESOLVED | — |
| Cystic Lung Disease | — | UNRESOLVED | — |
| Interstitial Lung Disease | — | UNRESOLVED | — |
| Lung Diseases | — | UNRESOLVED | — |
| Lymphocytic Interst. Pneumonitis | — | UNRESOLVED | — |
| Primary Pulmonary Lymphoma (Disorder) | — | UNRESOLVED | — |
| Sjogren's Syndrome | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (2)
- label
- Reduced Salivary Flow Patients
- description
- Patients with lung disease matching inclusion criteria who screen positive for reduced salivary flow
- label
- Normal Salivary Flow Patients
- description
- Patients with lung disease matching inclusion criteria who screen negative for reduced salivary flow
Primary outcomes (1)
- measure
- Change in pulmonary function over time
- timeFrame
- Change from first test after enrollment to final test across 5-year monitoring period
- description
- Based on underlying lung disease, standard measures of lung function (FEV1 vs FVC) will be followed
Secondary outcomes (2)
- measure
- Annual rate of hospitalizations from respiratory cause
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 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 * 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. Exclusion Criteria: * 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
References
Publications (0)
Data not yet available