Microaspiration in Pulmonary Fibrosis

Completed

• Conditions: Idiopathic Pulmonary Fibrosis

• Registration Number: NCT01150591
• Lead Sponsor: 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).

Detailed Description

Not available

Study Timeline

• Study Start: 2009-12
• Study First Submitted: 2010-06-23
• Study First Submitted QC: 2010-06-24
• Study First Posted: 2010-06-25
• Primary Completion: 2015-06
• Study Completion: 2015-06
• Status Verified: 2015-12
• Last Update Submitted: 2015-12-01
• Last Update Posted: 2015-12-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Diagnosis of IPF
• Ability ot provide informed consent

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
BAL pepsin level	Cross sectional

Trial Locations

Locations (1)

University of California San Francisco; 🇺🇸 San Francisco, California, United States