Status:
SUSPENDED
Sjogren's Lung Study
Lead Sponsor:
Stanford University
Conditions:
Sjogren's Syndrome
Interstitial Lung Disease
Eligibility:
All Genders
18+ years
Brief 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...
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 r...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
April 1 2030
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT04843345
Start Date
April 1 2021
End Date
April 1 2030
Last Update
October 27 2022
Active Locations (1)
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1
Stanford University
Stanford, California, United States, 94305