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The Role of Laryngopharyngeal Reflux in IPF

The Role of Laryngopharyngeal Reflux in IPF

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03418350
Enrollment
60
Registered
2018-02-01
Start date
2018-08-01
Completion date
2026-12-31
Last updated
2024-11-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

IPF, Reflux

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).

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.

Interventions

None listed

Sponsors

National Jewish Health
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
40 Years to 95 Years
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

Design outcomes

Primary

MeasureTime frameDescription
The supraglottic index (SGI) quantifies laryngopharyngeal reflux (LPF) and is associated with severity of pulmonary fibrosis.6 monthsCorrelation 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.

Countries

United States

Contacts

Primary ContactMatthew Koslow, MPH
ILDresearch@njhealth.org303-398-1996

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026