The Role of Laryngopharyngeal Reflux in IPF

Recruiting

• Conditions: Reflux; IPF

• Registration Number: NCT03418350
• Lead Sponsor: National Jewish Health

Brief Summary

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).

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.

Study Timeline

• Study First Submitted: 2018-01-23
• Study First Submitted QC: 2018-01-30
• Study First Posted: 2018-02-01
• Study Start: 2018-08-01
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-12
• Last Update Posted: 2024-11-14
• Primary Completion: 2025-12
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The supraglottic index (SGI) quantifies laryngopharyngeal reflux (LPF) and is associated with severity of pulmonary fibrosis.	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.

Trial Locations

Locations (1)

National Jewish Health; 🇺🇸 Denver, Colorado, United States