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Recruiting NCT03418350

The Role of Laryngopharyngeal Reflux in IPF

— Observational IPF Reflux

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: IPF, Reflux. Basic parameters: 40 years — 95 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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.

Primary outcome measures

  • The supraglottic index (SGI) quantifies laryngopharyngeal reflux (LPF) and is associated with severity of pulmonary fibrosis. [Time frame: 6 months]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United States · 1 center
  • National Jewish Health — Denver

Identifiers

NCT: NCT03418350 · HS-3130

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗