Positive Predictive Value of the Dx-pH Probe for Predicting PPI Response in LPR

April 23, 2024 updated by: Northwestern University

A Prospective Evaluation of the Utility, Optimal Cutoff and Positive Predictive Value of a Pharyngeal Potential of Hydrogen (pH) Probe for Predicting Proton Pump Inhibitor Response in Treatment Naive Laryngopharyngeal Reflux

The purpose of this research study is to better understand whether information obtained from a pH probe can help physicians predict whether a patient will respond to the medication that is prescribed for laryngopharyngeal reflux (LPR). The current treatment given to individuals who are diagnosed with LPR is a course of proton pump inhibitor (PPI) medication. Subjects who agree to participate in this study will have a small flexible tube (about the width of a piece of cooked spaghetti) placed in their throat. This tube measures the pH in the throat over a period of 24 hours and helps physicians study the relationship between pH level, LPR symptoms, and the effectiveness of PPI therapy. This study may help physicians find out if certain symptoms or characteristics can help them predict if the PPI medication will be effective for each patient. After probe removal, subjects will receive compensation. They will return to the clinic at their regularly scheduled follow-up visit with the physician, 8 to 12 weeks after starting the PPI medication. At that time, subjects can choose to participate in an optional probe placement.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The purpose of this research study is to better understand whether information obtained from a pH probe can help physicians predict whether a patient will respond to the medication that is prescribed for laryngopharyngeal reflux (LPR). The current treatment given to individuals who are diagnosed with LPR is a course of proton pump inhibitor (PPI) medication. This medication reduces the amount of gastric acid that is produced and generally leads to symptom relief. In order to study whether the pH probe can help physicians predict if the patient will respond to PPI therapy, the physicians will measure the pH level of patients' throats before they start PPI medication. Subjects who agree to participate in this study will have a small flexible tube (about the width of a piece of uncooked spaghetti) placed in their throat. The physician will place the tube through the nose until the tip is in the back of the throat, high enough so that the patient will not feel it when they talk, eat, drink, or swallow. This tube measures the pH in the throat over a period of 24 hours and helps physicians study the relationship between pH level, LPR symptoms, and the effectiveness of PPI therapy. This study may help physicians find out if certain symptoms or characteristics can help them predict if the PPI medication will be effective for each patient. After probe removal, subjects will receive compensation. They will return to the clinic at their regularly scheduled follow-up visit with the physician, 8 to 12 weeks after starting the PPI medication. At that time, subjects can choose to participate in an optional probe placement.

Study Type

Observational

Enrollment (Actual)

42

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern Medical Faculty Foundation (NMFF) Sinus and Allergy Center

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

14 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

People receiving care at Northwestern Medicine for laryngeal symptoms

Description

Inclusion Criteria:

  • Patients presenting for evaluation for symptoms classically associated with LPR with a Reflux Symptom Index (RSI) of greater than or equal to 13. The most common symptoms associated with LPR include hoarseness, throat clearing, globus sensation, nocturnal laryngospasm, postnasal drip, chronic cough, and dysphagia.
  • Symptom duration of greater than 1 month
  • Ages 18-89

Exclusion Criteria:

  • Pre-existing PPI therapy for any indication within two weeks of Dx-pH probe placement visit
  • Presence of findings of alternative diagnosis explaining symptoms e.g.: laryngeal mass, objective post nasal drainage
  • Contraindication to PPI therapy (i.e.: atrophic gastritis, liver problems, severe bloody diarrhea from antibiotics, osteoporosis, broken bone) or unwillingness to initiate PPI therapy
  • Pregnancy: There is no contraindication for the Restech pH probe and pregnancy; however, PPI use in pregnant women is contraindicated and thus pregnant women would be ineligible to participate in this study because they would be unable to complete a course of omeprazole.
  • Unwillingness or inability to undergo 24 hour pharyngeal pH probe monitoring (for example, oxygen wearing requirement that prevents probe placement or anatomical preclusions like septal perforation).
  • Bleeding disorder and/or unable to stop use of anticoagulants such as aspirin, Coumadin (warfarin), and/or Plavix (clopidogrel)

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

Cohorts and Interventions

Group / Cohort
Adult patients with Reflux Symptom Index scores (RSI) greater than or equal to 13 off PPI therapy
  1. Restech pH probe placement at initial clinic visit; subject returns 24 hrs later for probe removal.
  2. Proton pump inhibitor (PPI) therapy; subject starts PPI medication (omeprazole 40mg once daily) and returns for follow-up visit 8-12 weeks later.
  3. Optional second pH probe placement at follow up visit; Subject returns 24 hours later for probe removal; Subject continues PPI medication for 2 more weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
RSI Score
Time Frame: 8-12 weeks after initial clinic visit
Change from baseline in RSI score at 8-12 weeks after initial clinic visit/initiation of treatment will be used to define a response to PPI therapy
8-12 weeks after initial clinic visit
Global improvement in self-reported symptoms
Time Frame: 8-12 weeks after initial clinic visit
Change from baseline in global improvement in self-reported symptoms at 8-12 weeks after initial clinic visit/initiation of treatment will be used to define response to PPI therapy
8-12 weeks after initial clinic visit

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Differences in pH between PPI responders and non-responders
Time Frame: 8-12 weeks after initial clinic visit
The Ryan score, total time (as a percent) and number of events below a pH of 4, 5, 6, and 7 will be compared between PPI responders and non-responders.
8-12 weeks after initial clinic visit
Effects of PPI therapy on reflux events
Time Frame: 8-12 weeks after initial clinic visit
All subjects will have the option of a second pH probe placement at the follow up clinic visit 8-12 weeks after the initial clinic visit to assess the effects of PPI therapy on reflux events.
8-12 weeks after initial clinic visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Northwestern University

Collaborators

Respiratory Technology Corporation

Investigators

  • Principal Investigator: Bruce Tan, MD, Northwestern University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

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

August 1, 2012

Primary Completion (Actual)

November 1, 2014

Study Completion (Actual)

August 1, 2016

Study Registration Dates

First Submitted

December 18, 2012

First Submitted That Met QC Criteria

December 18, 2012

First Posted (Estimated)

December 24, 2012

Study Record Updates

Last Update Posted (Actual)

April 24, 2024

Last Update Submitted That Met QC Criteria

April 23, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 71707

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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