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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Northwestern University
Sponsor:
Collaborator:
Restech- Respiratory Technology Corporation
Information provided by (Responsible Party):
Bruce Tan, Northwestern University
ClinicalTrials.gov Identifier:
NCT01755221
First received: December 18, 2012
Last updated: June 4, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention
Laryngopharyngeal Reflux (LPR)
Extraesophageal Reflux
Reflux Laryngitis
Posterior Laryngitis
Other: Single-center prospective evaluation of the Restech pH probe

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
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

Resource links provided by NLM:


Further study details as provided by Northwestern University:

Primary Outcome Measures:
  • RSI Score [ Time Frame: 8-12 weeks after initial clinic visit ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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


Secondary Outcome Measures:
  • Differences in pH between PPI responders and non-responders [ Time Frame: 8-12 weeks after initial clinic visit ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 80
Study Start Date: December 2012
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Single-center prospective evaluation of the Restech pH probe
  1. Restech pH probe placement at initial clinic visit; Subject returns 24 hours 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
Other: Single-center prospective evaluation of the Restech pH probe
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 89 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01755221

Contacts
Contact: Caroline Price 312-695-0513 caroline.price@northwestern.edu

Locations
United States, Illinois
Northwestern Medical Faculty Foundation (NMFF) Sinus and Allergy Center Recruiting
Chicago, Illinois, United States, 60611
Contact: Caroline Price    312-695-0513    caroline.price@northwestern.edu   
Principal Investigator: Bruce Tan, MD         
Sub-Investigator: Stephanie Shintani Smith, MD         
Sub-Investigator: John Pandolfino, MD         
Sub-Investigator: Andrew Gawron, MD         
Sub-Investigator: Michiel Bove, MD         
Sponsors and Collaborators
Northwestern University
Restech- Respiratory Technology Corporation
Investigators
Principal Investigator: Bruce Tan, MD Northwestern University
  More Information

Additional Information:
Publications:

Responsible Party: Bruce Tan, MD, Assistant Professor, Dept of Otolaryngology, Northwestern University Feinberg School of Medicine, Northwestern University
ClinicalTrials.gov Identifier: NCT01755221     History of Changes
Other Study ID Numbers: 71707
Study First Received: December 18, 2012
Last Updated: June 4, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Northwestern University:
Laryngopharyngeal reflux (LPR)
Extraesophageal reflux
Reflux laryngitis
Posterior laryngitis
Proton pump inhibitor (PPI) medication
Restech pH probe

Additional relevant MeSH terms:
Gastroesophageal Reflux
Laryngitis
Regurgitation, Gastric
Laryngeal Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 29, 2014