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

• ClinicalTrials.gov Identifier: NCT01755221
• Recruitment Status: Unknown
• First Posted: December 24, 2012
• Last Update Posted: December 16, 2014
• Sponsor: Northwestern University
• Collaborator: Restech- Respiratory Technology Corporation
• Information provided by (Responsible Party): Bruce Tan, Northwestern University

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.

Condition or disease	Intervention/treatment	Phase
Laryngopharyngeal Reflux (LPR); Extraesophageal Reflux; Reflux Laryngitis; Posterior Laryngitis	Other: Single-center prospective evaluation of the Restech pH probe	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 80 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (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
• Study Start Date: August 2012
• Actual Primary Completion Date: November 2014
• Estimated Study Completion Date: December 2015

Arms and Interventions

Arm

Intervention/treatment

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.

Outcome Measures

Primary Outcome Measures :

1. 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
2. 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

Secondary Outcome Measures :

1. 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.
2. 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 89 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

Locations

United States, Illinois

Northwestern Medical Faculty Foundation (NMFF) Sinus and Allergy Center

Chicago, Illinois, United States, 60611

Sponsors and Collaborators

Northwestern University

Restech- Respiratory Technology Corporation

Investigators

• Principal Investigator: Bruce Tan, MD; Northwestern University

More Information

Additional Information:

Related Information 

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
• Other Study ID Numbers: 71707
• First Posted: December 24, 2012
• Last Update Posted: December 16, 2014
• Last Verified: December 2014

Keywords provided by Bruce Tan, 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; Laryngopharyngeal Reflux; Croup; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Laryngeal Diseases; Respiratory Tract Diseases; Respiratory Tract Infections; Infections; Otorhinolaryngologic Diseases