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Trial record 1 of 3 for:    Microaspiration in Pulmonary Fibrosis
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Microaspiration in Pulmonary Fibrosis (ROMI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01150591
Recruitment Status : Completed
First Posted : June 25, 2010
Last Update Posted : December 2, 2015
Information provided by (Responsible Party):
University of California, San Francisco

Brief Summary:

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

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Study Type : Observational
Actual Enrollment : 20 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Primary Outcome Measures :
  1. BAL pepsin level [ Time Frame: Cross sectional ]

Biospecimen Description:
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).

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with IPF

Inclusion Criteria:

  • Diagnosis of IPF
  • Ability ot provide informed consent

Exclusion Criteria:

  • History of fundoplication or other gastroesophageal surgery
  • Too ill to undergo bronchoscopy in the opinion of the investigator

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01150591

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United States, California
University of California San Francisco
San Francisco, California, United States, 94610
Sponsors and Collaborators
University of California, San Francisco

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Responsible Party: University of California, San Francisco Identifier: NCT01150591     History of Changes
Other Study ID Numbers: F32HL097383 ( U.S. NIH Grant/Contract )
First Posted: June 25, 2010    Key Record Dates
Last Update Posted: December 2, 2015
Last Verified: December 2015

Additional relevant MeSH terms:
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Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
Idiopathic Interstitial Pneumonias
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Lung Diseases, Interstitial