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Microaspiration in Pulmonary Fibrosis (ROMI)

This study is currently recruiting participants.
Verified July 2012 by University of California, San Francisco
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT01150591
First received: June 23, 2010
Last updated: July 2, 2012
Last verified: July 2012
History of Changes
  Purpose

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
Idiopathic Pulmonary Fibrosis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Role of Microaspiration in Idiopathic Pulmonary Fibrosis

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of California, San Francisco:

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).


Estimated Enrollment: 30
Study Start Date: December 2009
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with IPF

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01150591

Locations
United States, California
University of California San Francisco Recruiting
San Francisco, California, United States, 94610
Contact: Jane Berkeley     415-353-1071     jane.berkeley@ucsf.edu    
Principal Investigator: Harold R Collard, MD            
Sponsors and Collaborators
University of California, San Francisco
  More Information

No publications provided

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01150591     History of Changes
Other Study ID Numbers: F32HL097383
Study First Received: June 23, 2010
Last Updated: July 2, 2012
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on May 16, 2013