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

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

Official Title: 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

Brief Summary: 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 Summary: 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.
Sponsor: Northwestern University

Current Primary Outcome:

  • 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
  • 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


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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.
  • 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.


Original Secondary Outcome: Same as current

Information By: Northwestern University

Dates:
Date Received: December 18, 2012
Date Started: August 2012
Date Completion: December 2015
Last Updated: December 12, 2014
Last Verified: December 2014