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NCT Number: NCT03418350

The Role of Laryngopharyngeal Reflux in IPF

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).

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Key information

Conditions

IPF Deglutition Disorders Digestive System Diseases Esophageal Diseases Esophageal Motility Disorders Gastroesophageal Reflux Gastrointestinal Diseases Reflux

Age range

40 year–95 year

Sex eligibility

All sexes

Study type

Observational

Primary location

National Jewish Health

Denver, Colorado, 80206, United States

Location status: Recruiting

Location contact

Tara Churney, MPH

CONTACT

[email protected]

303-398-1996

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Matthew Koslow, MPH

CONTACT

[email protected]

303-398-1996

Sponsors and collaborators

Lead sponsor

National Jewish Health

Other

Registry information

Important dates

Study start
2018
Primary completion
2025
Study completion
2026
First posted
Feb 1, 2018
Registry last updated
Nov 14, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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