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 ]
|Study Start Date:||December 2009|
|Study Completion Date:||June 2015|
|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|