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The Role of Laryngopharyngeal Reflux in IPF

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ClinicalTrials.gov Identifier: NCT03418350
Recruitment Status : Recruiting
First Posted : February 1, 2018
Last Update Posted : October 19, 2020
Sponsor:
Information provided by (Responsible Party):
Jeff Swigris, National Jewish Health

Study Description
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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
IPF Reflux

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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: GERD

Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  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.


Eligibility Criteria
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Ages Eligible for Study:   40 Years to 95 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
ILD clinic
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03418350


Contacts
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Contact: Tara Churney, MPH 303-398-1996 ILDresearch@njhealth.org

Locations
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United States, Colorado
National Jewish Health Recruiting
Denver, Colorado, United States, 80206
Contact: Tara Churney, MPH    303-398-1996    ILDresearch@njhealth.org   
Sponsors and Collaborators
National Jewish Health
Investigators
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Principal Investigator: Jeff Swigris, DO National Jewish Health
More Information
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Responsible Party: Jeff Swigris, Associate Professor, National Jewish Health
ClinicalTrials.gov Identifier: NCT03418350    
Other Study ID Numbers: HS-3130
First Posted: February 1, 2018    Key Record Dates
Last Update Posted: October 19, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No IPD will be available to other researchers.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Gastroesophageal Reflux
Laryngopharyngeal Reflux
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
 Gastrointestinal Diseases
Digestive System Diseases
Laryngeal Diseases
Respiratory Tract Diseases