Microaspiration in Pulmonary Fibrosis (ROMI)
Hypothesis 1: Microaspiration, as diagnosed by bronchoalveolar lavage (BAL) pepsin, is common in patients with IPF.
Hypothesis 2a: Baseline clinical variables and co-morbid conditions are risk factors for microaspiration in patients with IPF.
Hypothesis 2b: Baseline biological variables reflecting alveolar epithelial injury and inflammation are markers of microaspiration in IPF.
Hypothesis 3a: Microaspiration will lead to a more rapid rate of decline in pulmonary function.
Hypothesis 3b: Microaspiration will lead to higher rates of urgent medical care use (i.e. unscheduled clinic visit, emergency room visit, or hospitalization).
Idiopathic Pulmonary Fibrosis
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||The Role of Microaspiration in Idiopathic Pulmonary Fibrosis|
- BAL pepsin level [ Time Frame: Cross sectional ] [ Designated as safety issue: No ]
This is a prospective cohort study of patients with IPF. Subjects will undergo (1) an assessment of the presence or absence of microaspiration (via bronchoscopy and BAL pepsin level), (2) measurement of biomarkers of microaspiration (via esophageal function studies, laboratory tests, pulmonary function, chest imaging, and survey), and (3) longitudinal follow-up to document disease progression (via pulmonary function and survey).
|Study Start Date:||December 2009|
|Estimated Study Completion Date:||June 2015|
|Estimated Primary Completion Date:||June 2015 (Final data collection date for primary outcome measure)|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01150591
|United States, California|
|University of California San Francisco|
|San Francisco, California, United States, 94610|