NCT04843345Suspended
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 · Last updated 27 Oct 2022
Brief summary (registry, in English)
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.
- Status (registry)
- Suspended
- Study type
- Observational
- Enrollment
- 500 (estimated)
- First submitted
- 8 Apr 2021
- Start date
- 1 Apr 2021
- Primary completion date
- 1 Apr 2028
- Lead sponsor
- Stanford University
- Diseases
- Sjögren's disease
- NCT number
- NCT04843345
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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).
Other
- Patients who have taken a muscarinic antagonist or agonists within 7 days of planned testing
- Patients who are unable to consent for themselves
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Stanford University Coordinator of this site? Confirm its status | Stanford | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.