Microaspiration in Pulmonary Fibrosis

NCT01150591 | Completed

• 1 other identifier: F32HL097383
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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).

Conditions

Idiopathic Pulmonary Fibrosis

Outcome Measures

Primary Outcomes (1)

• BAL pepsin level

  Cross sectional

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with IPF

You may qualify if:

• Diagnosis of IPF
• Ability ot provide informed consent

You may not qualify if:

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

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

University of California San Francisco

San Francisco, California, 94610, United States

Location

Biospecimen

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).

MeSH Terms

Conditions

Idiopathic Pulmonary Fibrosis

Condition Hierarchy (Ancestors)

Pulmonary Fibrosis; Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 23, 2010
• First Posted: June 25, 2010
• Study Start: December 1, 2009
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: December 2, 2015

Record last verified: 2015-12

Locations

US (1)