Microaspiration in Pulmonary Fibrosis (ROMI)
|ClinicalTrials.gov Identifier: NCT01150591|
Recruitment Status : Completed
First Posted : June 25, 2010
Last Update Posted : December 2, 2015
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).
|Condition or disease|
|Idiopathic Pulmonary Fibrosis|
|Study Type :||Observational|
|Actual Enrollment :||20 participants|
|Official Title:||The Role of Microaspiration in Idiopathic Pulmonary Fibrosis|
|Study Start Date :||December 2009|
|Actual Primary Completion Date :||June 2015|
|Actual Study Completion Date :||June 2015|
- BAL pepsin level [ Time Frame: Cross sectional ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01150591
|United States, California|
|University of California San Francisco|
|San Francisco, California, United States, 94610|