The Role of Laryngopharyngeal Reflux in IPF

Overview

The primary objective of this study is to show that the Supraglottic Index (SGI) is an easily-collected index that accurately identifies the presence and severity of laryngopharyngeal reflux (LPF) in idiopathic pulmonary fibrosis (IPF).

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: December 2024

Detailed Description

The study team hypothesizes the SGI will correlate more strongly with measures of IPF severity (at baseline and over time) than gastroesophageal reflux (GER) data derived from the esophageal detector channels of a pH/impedance probe.

Clinical Trial Outcome Measures

Primary Measures

  • The supraglottic index (SGI) quantifies laryngopharyngeal reflux (LPF) and is associated with severity of pulmonary fibrosis.
    • Time Frame: 6 months
    • Correlation between the supraglottic index and forced vital capacity. The supraglottic index is an index derived by assigning scores for edema and erythema of five supraglottic structures (epiglottis, false cords, arytenoids, posterior commissure, piriform recess) as viewed through a fiber-optic scope. Scores range from 0-22, with higher scores indicating more severe LPR.

Participating in This Clinical Trial

Inclusion Criteria

  • Diagnosis of IPF – Age 40-95 – Able to read, speak, and understand English – If subjects are currently taking medication for reflux or GERD, they much be on a stable does for at least 4 weeks prior to consent. Exclusion Criteria:

  • Patients who do not meet all inclusion criteria – Pregnant females

Gender Eligibility: All

Minimum Age: 40 Years

Maximum Age: 95 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • National Jewish Health
  • Provider of Information About this Clinical Study
    • Principal Investigator: Jeff Swigris, Associate Professor – National Jewish Health
  • Overall Official(s)
    • Jeff Swigris, DO, Principal Investigator, National Jewish Health
  • Overall Contact(s)
    • Tara Churney, MPH, 303-398-1996, ILDresearch@njhealth.org

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