ClinicalTrials.gov
ClinicalTrials.gov Menu

The Role of Laryngopharyngeal Reflux in IPF

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03418350
Recruitment Status : Recruiting
First Posted : February 1, 2018
Last Update Posted : August 27, 2018
Sponsor:
Information provided by (Responsible Party):
Jeff Swigris, 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).

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 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




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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

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

Locations
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
Principal Investigator: Jeff Swigris, DO National Jewish Health

Responsible Party: Jeff Swigris, Associate Professor, National Jewish Health
ClinicalTrials.gov Identifier: NCT03418350     History of Changes
Other Study ID Numbers: HS-3130
First Posted: February 1, 2018    Key Record Dates
Last Update Posted: August 27, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No IPD will be available to other researchers.

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
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Laryngeal Diseases
Respiratory Tract Diseases