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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Laryngopharyngeal Reflux (LPR), Extraesophageal Reflux, Reflux Laryngitis, Posterior Laryngitis

Intervention / Treatment
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* Other: Single-center prospective evaluation of the Restech pH probe


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 89 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Single-center prospective evaluation of the Restech pH probe<br>Restech pH probe placement at initial clinic visit; Subject returns 24 hours later for probe removal Proton pump inhibitor (PPI) therapy; Subject starts PPI medication (omeprazole 40mg once daily) and returns for follow-up visit 8-12 weeks later 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 | Other: Single-center prospective evaluation of the Restech pH probe<br>* All subjects will have a pH probe placed at their initial clinic visit and will have the probe removed 24 hours later. They will start on PPI medication (as per the standard of care) after probe removal. Subjects will have a follow up clinic visit 8-12 weeks after the initial visit. At the follow up visit, all subjects will have the option of a second probe placement to assess the effects of PPI therapy on reflux events.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| RSI Score | 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 | 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 | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Laryngopharyngeal reflux (LPR), Extraesophageal reflux, Reflux laryngitis, Posterior laryngitis, Proton pump inhibitor (PPI) medication, Restech pH probe