Microaspiration in Pulmonary Fibrosis

The Role of Microaspiration in Idiopathic Pulmonary Fibrosis

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01150591

Acronym

ROMI

Enrollment

Registered

2010-06-25

Start date

2009-12-31

Completion date

2015-06-30

Last updated

2015-12-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Idiopathic Pulmonary Fibrosis

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).

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 100 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
BAL pepsin level	Cross sectional

Countries

United States

Outcome results