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The Role of Laryngopharyngeal Reflux in IPF

Sponsor
National Jewish Health (Other)
Overall Status
Recruiting
CT.gov ID
NCT03418350
Collaborator
(none)
60
Enrollment
1
Location
28
Anticipated Duration (Months)
2.1
Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Anticipated Enrollment :
    60 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    The Role of Laryngopharyngeal Reflux in IPF
    Actual Study Start Date :
    Aug 1, 2018
    Anticipated Primary Completion Date :
    Dec 1, 2020
    Anticipated Study Completion Date :
    Dec 1, 2020

    Outcome Measures

    Primary Outcome Measures

    1. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    40 Years to 95 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 National Jewish Health Denver Colorado United States 80206

    Sponsors and Collaborators

    • National Jewish Health

    Investigators

    • Principal Investigator: Jeff Swigris, DO, National Jewish Health

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Jeff Swigris, Associate Professor, National Jewish Health
    ClinicalTrials.gov Identifier:
    NCT03418350
    Other Study ID Numbers:
    • HS-3130
    First Posted:
    Feb 1, 2018
    Last Update Posted:
    Oct 19, 2020
    Last Verified:
    Oct 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Gastroesophageal Reflux
    Laryngopharyngeal Reflux

    Study Results

    No Results Posted as of Oct 19, 2020