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

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.

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:

MedlinePlus related topics: GERD

U.S. FDA Resources

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 2014
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 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 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.

Arms

Assigned Interventions

Single-center prospective evaluation of the Restech pH probe

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

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.

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

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

Contacts

Contact: Alcina Lidder

312-695-0513

alcinalidder@northwestern.edu

Locations

United States, Illinois
Northwestern Medical Faculty Foundation (NMFF) Sinus and Allergy Center	Recruiting
Chicago, Illinois, United States, 60611
Contact: Alcina Lidder 312-695-0513 alcinalidder@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:

Related Information This link exits the ClinicalTrials.gov site

Publications:

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.

Belafsky PC, Postma GN, Koufman JA. Validity and reliability of the reflux symptom index (RSI). J Voice. 2002 Jun;16(2):274-7.

Belafsky PC, Postma GN, Koufman JA. Laryngopharyngeal reflux symptoms improve before changes in physical findings. Laryngoscope. 2001 Jun;111(6):979-81.

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.

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.

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. Review.

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.

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.

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.

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:	December 18, 2012
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:

Laryngitis
Gastroesophageal Reflux
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 May 16, 2013