Sjogren's Lung Study

NCT04843345 | Suspended

• 1 other identifier: IRB-59313
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

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 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

Sjogren's Syndrome; Interstitial Lung Disease; Primary Pulmonary Lymphoma (Disorder); Chronic Bronchiolitis; Bronchiectasis; Lung Diseases; Cystic Lung Disease; Lymphocytic Interst. Pneumonitis

Outcome Measures

Primary Outcomes (1)

• Change in pulmonary function over time

  Based on underlying lung disease, standard measures of lung function (FEV1 vs FVC) will be followed

  Change from first test after enrollment to final test across 5-year monitoring period

Secondary Outcomes (2)

• Annual rate of hospitalizations from respiratory cause

  Over 5-year monitoring period

• Percent of participants who die from respiratory cause

  Over 5-year monitoring period

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Sjogren's Syndrome; Lung Diseases, Interstitial; Bronchiectasis; Lung Diseases; Cystic Disease Of Lung; Lymphoid Interstitial Pneumonia

Condition Hierarchy (Ancestors)

Arthritis, Rheumatoid; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Xerostomia; Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases; Dry Eye Syndromes; Lacrimal Apparatus Diseases; Eye Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Respiratory Tract Diseases; Bronchial Diseases

Study Officials

• Jason H Melehani, MD, PhD

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Fellow

Study Record Dates

• First Submitted: April 8, 2021
• First Posted: April 13, 2021
• Study Start: April 1, 2021
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): April 1, 2030
• Last Updated: October 27, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)