ClinicalTrials.gg
RecruitingNCT03418350Updated Nov 14, 2024

The Role of Laryngopharyngeal Reflux in IPF

An observational study in IPF and Reflux, sponsored by National Jewish Health. Recruiting at 1 site in United States. Open to participants aged 40 Years to 95 Years. Per ClinicalTrials.gov, last updated 2024-11-14.

Sponsored by National Jewish Health · Observational

From the registry’s dates

  • Primary completion was expected by Dec 2025, 11 months ago, but the record still lists the study as recruiting.
  • Started Aug 2018; still recruiting 8 years 3 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
60
Ages
40 Years to 95 Years
Sex
All
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Study 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).

Read the 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.

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Conditions studied

  • IPF
  • Reflux
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In context

Gastroesophageal Reflux

1,211 studies on the registry are indexed under Gastroesophageal Reflux; 202 are open to participants now.

This study's planned enrollment of 60 is below the median of 178 across 348 observational studies indexed under Gastroesophageal Reflux.

Browse Gastroesophageal Reflux studies →

Lead sponsor

National Jewish Health is the lead sponsor of 109 studies on the registry; 14 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
40 Years to 95 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

ILD clinic

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Patients who do not meet all inclusion criteria
  • Pregnant females
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
60 participants (estimated)
Patient registry
No
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What researchers measure

Primary outcomes

  1. The supraglottic index (SGI) quantifies laryngopharyngeal reflux (LPF) and is associated with severity of pulmonary fibrosis.

    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.

    Time frame: 6 months

07

Study locations

1 of 1 sites recruiting
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References and documents

Individual participant data

Plan to share: No — No IPD will be available to other researchers.

No publications or documents are linked to this record.

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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Aug 2018 (actual). Primary completion is estimated for Dec 2025, 88 months after the start.

Of 95 non-industry observational studies under Gastroesophageal Reflux, half reached primary completion within 57 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 167. This study's planned 88 months is above that.

Counting every sponsor, half of 116 studies reached it within 45 months; a quarter within 17 and three quarters within 167.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 23, 2018
First posted
Feb 1, 2018
StartActual
Aug 1, 2018
Primary completionEst.
Dec 2025
CompletionEst.
Dec 2026
Last update
Nov 14, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 14, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03418350
Responsible party
Jeff Swigris (Associate Professor, National Jewish Health) — Principal investigator
First posted
Feb 1, 2018
Start date
Aug 1, 2018
Primary completion
Dec 2025 (estimated)
Completion
Dec 2026 (estimated)
Last update
Nov 14, 2024

Study contacts

Matthew Koslow, MPH
Contact
ILDresearch@njhealth.org
303-398-1996
Matthew Koslow, DO
principal investigator · National Jewish Health

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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