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

Primary Purpose

Laryngopharyngeal Reflux (LPR), Extraesophageal Reflux, Reflux Laryngitis

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Single-center prospective evaluation of the Restech pH probe
Sponsored by
Northwestern University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Laryngopharyngeal Reflux (LPR) focused on measuring Laryngopharyngeal reflux (LPR), Extraesophageal reflux, Reflux laryngitis, Posterior laryngitis, Proton pump inhibitor (PPI) medication, Restech pH probe

Eligibility Criteria

18 Years - 89 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Northwestern Medical Faculty Foundation (NMFF) Sinus and Allergy Center

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Single-center prospective evaluation of the Restech pH probe

Arm Description

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

Outcomes

Primary Outcome Measures

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
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

Secondary Outcome Measures

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.
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.

Full Information

First Posted
December 18, 2012
Last Updated
December 12, 2014
Sponsor
Northwestern University
Collaborators
Restech- Respiratory Technology Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT01755221
Brief Title
Positive Predictive Value of the Dx-pH Probe for Predicting PPI Response in LPR
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2014
Overall Recruitment Status
Unknown status
Study Start Date
August 2012 (undefined)
Primary Completion Date
November 2014 (Actual)
Study Completion Date
December 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwestern University
Collaborators
Restech- Respiratory Technology Corporation

4. Oversight

Data Monitoring Committee
No

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Laryngopharyngeal Reflux (LPR), Extraesophageal Reflux, Reflux Laryngitis, Posterior Laryngitis
Keywords
Laryngopharyngeal reflux (LPR), Extraesophageal reflux, Reflux laryngitis, Posterior laryngitis, Proton pump inhibitor (PPI) medication, Restech pH probe

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Single-center prospective evaluation of the Restech pH probe
Arm Type
Other
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Single-center prospective evaluation of the Restech pH probe
Intervention Description
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.
Primary Outcome Measure Information:
Title
RSI Score
Description
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
Time Frame
8-12 weeks after initial clinic visit
Title
Global improvement in self-reported symptoms
Description
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
Time Frame
8-12 weeks after initial clinic visit
Secondary Outcome Measure Information:
Title
Differences in pH between PPI responders and non-responders
Description
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.
Time Frame
8-12 weeks after initial clinic visit
Title
Effects of PPI therapy on reflux events
Description
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.
Time Frame
8-12 weeks after initial clinic visit

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bruce Tan, MD
Organizational Affiliation
Northwestern University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Northwestern Medical Faculty Foundation (NMFF) Sinus and Allergy Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
12160267
Citation
Branski RC, Bhattacharyya N, Shapiro J. The reliability of the assessment of endoscopic laryngeal findings associated with laryngopharyngeal reflux disease. Laryngoscope. 2002 Jun;112(6):1019-24. doi: 10.1097/00005537-200206000-00016.
Results Reference
background
PubMed Identifier
12150380
Citation
Belafsky PC, Postma GN, Koufman JA. Validity and reliability of the reflux symptom index (RSI). J Voice. 2002 Jun;16(2):274-7. doi: 10.1016/s0892-1997(02)00097-8.
Results Reference
background
PubMed Identifier
11404607
Citation
Belafsky PC, Postma GN, Koufman JA. Laryngopharyngeal reflux symptoms improve before changes in physical findings. Laryngoscope. 2001 Jun;111(6):979-81. doi: 10.1097/00005537-200106000-00009.
Results Reference
background
PubMed Identifier
15128336
Citation
Williams RB, Szczesniak MM, Maclean JC, Brake HM, Cole IE, Cook IJ. Predictors of outcome in an open label, therapeutic trial of high-dose omeprazole in laryngitis. Am J Gastroenterol. 2004 May;99(5):777-85. doi: 10.1111/j.1572-0241.2004.04151.x.
Results Reference
background
PubMed Identifier
15180717
Citation
Kawamura O, Aslam M, Rittmann T, Hofmann C, Shaker R. Physical and pH properties of gastroesophagopharyngeal refluxate: a 24-hour simultaneous ambulatory impedance and pH monitoring study. Am J Gastroenterol. 2004 Jun;99(6):1000-10. doi: 10.1111/j.1572-0241.2004.30349.x.
Results Reference
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PubMed Identifier
19786155
Citation
Ali T, Roberts DN, Tierney WM. Long-term safety concerns with proton pump inhibitors. Am J Med. 2009 Oct;122(10):896-903. doi: 10.1016/j.amjmed.2009.04.014.
Results Reference
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PubMed Identifier
22301104
Citation
Friedman M, Hamilton C, Samuelson CG, Kelley K, Taylor R, Darling R, Taylor D, Fisher M, Maley A. The value of routine pH monitoring in the diagnosis and treatment of laryngopharyngeal reflux. Otolaryngol Head Neck Surg. 2012 Jun;146(6):952-8. doi: 10.1177/0194599812436952. Epub 2012 Feb 2.
Results Reference
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PubMed Identifier
19421822
Citation
Ayazi S, Lipham JC, Hagen JA, Tang AL, Zehetner J, Leers JM, Oezcelik A, Abate E, Banki F, DeMeester SR, DeMeester TR. A new technique for measurement of pharyngeal pH: normal values and discriminating pH threshold. J Gastrointest Surg. 2009 Aug;13(8):1422-9. doi: 10.1007/s11605-009-0915-6. Epub 2009 May 7.
Results Reference
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PubMed Identifier
22450948
Citation
Becker V, Graf S, Schlag C, Schuster T, Feussner H, Schmid RM, Bajbouj M. First agreement analysis and day-to-day comparison of pharyngeal pH monitoring with pH/impedance monitoring in patients with suspected laryngopharyngeal reflux. J Gastrointest Surg. 2012 Jun;16(6):1096-101. doi: 10.1007/s11605-012-1866-x. Epub 2012 Mar 27.
Results Reference
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Links:
URL
http://www.northwestern-sinus.com/
Description
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Positive Predictive Value of the Dx-pH Probe for Predicting PPI Response in LPR

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