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NCT01150591 Clinical Trial

Microaspiration in Pulmonary Fibrosis

Idiopathic Pulmonary Fibrosis Clinical Trial

— ROMI  

Official title:
The Role of Microaspiration in Idiopathic Pulmonary Fibrosis

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01150591
Other study ID # F32HL097383
Secondary ID
Status Completed
Phase N/A
First received June 23, 2010
Last updated December 1, 2015
Start date December 2009
Est. completion date June 2015

Study information
Verified date December 2015
Source University of California, San Francisco
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial 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).

Recruitment information / eligibility
Status Completed
Enrollment 20
Est. completion date June 2015
Est. primary completion date June 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 100 Years
Eligibility 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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
United States University of California San Francisco San Francisco California

Sponsors (1)
Lead Sponsor Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary BAL pepsin level Cross sectional No
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