The Role of Laryngopharyngeal Reflux in IPF
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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 : September 27, 2022
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Condition or disease |
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IPF Reflux |
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 2024 |
Estimated Study Completion Date : | December 2025 |
- 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.

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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 |
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

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
Contact: Tara Churney, MPH | 303-398-1996 | ILDresearch@njhealth.org |
United States, Colorado | |
National Jewish Health | Recruiting |
Denver, Colorado, United States, 80206 | |
Contact: Tara Churney, MPH 303-398-1996 ILDresearch@njhealth.org |
Principal Investigator: | Jeff Swigris, DO | National Jewish Health |
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: | September 27, 2022 |
Last Verified: | September 2022 |
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 |
Gastroesophageal Reflux Laryngopharyngeal Reflux Esophageal Motility Disorders Deglutition Disorders Esophageal Diseases |
Gastrointestinal Diseases Digestive System Diseases Laryngeal Diseases Respiratory Tract Diseases |