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

NCT ID: NCT01755221

Last Updated: 2024-04-24

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 42 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-08-31
• Study Completion Date: 2016-08-31

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.

Conditions

Laryngopharyngeal Reflux (LPR); Extraesophageal Reflux; Reflux Laryngitis; Posterior Laryngitis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Adult patients with Reflux Symptom Index scores (RSI) greater than or equal to 13 off PPI therapy

1. Restech pH probe placement at initial clinic visit; subject returns 24 hrs 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

No interventions assigned to this group

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 89 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Respiratory Technology Corporation

INDUSTRY

Sponsor Role: collaborator

Northwestern University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bruce Tan, MD

Role: PRINCIPAL_INVESTIGATOR

Northwestern University

Locations

Northwestern Medical Faculty Foundation (NMFF) Sinus and Allergy Center

Chicago, Illinois, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 12160267 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 12150380 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 11404607 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 15128336 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 15180717 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19786155 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 22301104 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19421822 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 22450948 (View on PubMed)

Yadlapati R, Pandolfino JE, Lidder AK, Shabeeb N, Jaiyeola DM, Adkins C, Agrawal N, Cooper A, Price CP, Ciolino JD, Gawron AJ, Smith SS, Bove M, Tan BK. Oropharyngeal pH Testing Does Not Predict Response to Proton Pump Inhibitor Therapy in Patients with Laryngeal Symptoms. Am J Gastroenterol. 2016 Nov;111(11):1517-1524. doi: 10.1038/ajg.2016.145. Epub 2016 Apr 19.

Reference Type: RESULT

PMID: 27091320 (View on PubMed)

Yadlapati R, Adkins C, Jaiyeola DM, Lidder AK, Gawron AJ, Tan BK, Shabeeb N, Price CP, Agrawal N, Ellenbogen M, Smith SS, Bove M, Pandolfino JE. Abilities of Oropharyngeal pH Tests and Salivary Pepsin Analysis to Discriminate Between Asymptomatic Volunteers and Subjects With Symptoms of Laryngeal Irritation. Clin Gastroenterol Hepatol. 2016 Apr;14(4):535-542.e2. doi: 10.1016/j.cgh.2015.11.017. Epub 2015 Dec 9.

Reference Type: RESULT

PMID: 26689899 (View on PubMed)

Other Identifiers

71707

Identifier Type: -

Identifier Source: org_study_id