- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03418350
The Role of Laryngopharyngeal Reflux in IPF
September 26, 2022 updated by: Jeff Swigris, National Jewish Health
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).
Study Overview
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
Enrollment (Anticipated)
60
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Tara Churney, MPH
- Phone Number: 303-398-1996
- Email: ILDresearch@njhealth.org
Study Locations
-
-
Colorado
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Denver, Colorado, United States, 80206
- Recruiting
- National Jewish Health
-
Contact:
- Tara Churney, MPH
- Phone Number: 303-398-1996
- Email: ILDresearch@njhealth.org
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years to 95 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
ILD clinic
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Jeff Swigris, DO, National Jewish Health
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 1, 2018
Primary Completion (Anticipated)
December 1, 2024
Study Completion (Anticipated)
December 1, 2025
Study Registration Dates
First Submitted
January 23, 2018
First Submitted That Met QC Criteria
January 30, 2018
First Posted (Actual)
February 1, 2018
Study Record Updates
Last Update Posted (Actual)
September 27, 2022
Last Update Submitted That Met QC Criteria
September 26, 2022
Last Verified
September 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HS-3130
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
No IPD will be available to other researchers.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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