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NCT03418350 Clinical Trial

The Role of Laryngopharyngeal Reflux in IPF

Reflux Clinical Trial

Official title:
The Role of Laryngopharyngeal Reflux in IPF

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03418350
Other study ID # HS-3130
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date August 1, 2018
Est. completion date December 2025

Study information
Verified date September 2022
Source National Jewish Health
Contact Tara Churney, MPH
Phone 303-398-1996
Email ILDresearch@njhealth.org
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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).

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 60
Est. completion date December 2025
Est. primary completion date December 2024
Accepts healthy volunteers No
Gender All
Age group 40 Years to 95 Years
Eligibility 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

Related Conditions & MeSH terms

Locations
Country Name City State
United States National Jewish Health Denver Colorado

Sponsors (1)
Lead Sponsor Collaborator
National Jewish Health

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary The supraglottic index (SGI) quantifies laryngopharyngeal reflux (LPF) and is associated with severity of pulmonary fibrosis. 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. 6 months
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