Evaluating Treatment Response in Laryngo-Pharyngeal Reflux

Although laryno-pharyngeal reflux (LPR) and gastroesophageal reflux disease (GERD) differ in symptoms and treatment, they are diagnosed by the same standard 24-hour pH monitoring system which measures liquid reflux in the esophagus. The investigators are evaluating a new 24-hour pharyngeal pH monitoring system by Restech which can measure acid exposure in the airway and can be used specifically for LPR diagnosis. The purpose of this study is to determine whether the Restech device is more effective than standard pH monitoring in predicting the response to proton pump inhibitor (PPI) acid suppression therapy using Dexlansoprazole in patients with symptoms and/or manifestations of LPR.

Study Overview

• Status: Withdrawn
• Conditions: Laryngo-pharyngeal Reflux
• Intervention / Treatment: Drug: Dexlansoprazole

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98105
      • University of Washington

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age 18 years old or above
• Have a clinical diagnosis of LPR
• Able and willing to provide consent

Exclusion Criteria:

• History of any previous anti-reflux operation or procedure
• History of pharyngeal or laryngeal surgery
• History of larngeal or hypolaryngeal neoplasm
• Allergy or significant adverse reaction to PPI
• Patient on PPI therapy within 4 weeks prior to enrollment
• A cumulative history of PPI therapy equal to or greater than 3 months
• History of noncompliance with medication or study protocols
• Enrolled in another clinical trial using investigational medications

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ability of Restech to predict LPR symptom improvement after treatment with Dexlansoprazole.	Successful LPR symptom improvement will be defined as a 25% improvement in Reflux Symptom Index (RSI)after 3 months of Dexlansoprazole.	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison between standard pH data and Restech data (normal vs.abnormal acid exposure, using established normative data values) before and after treatment with Dexlansoprazole.		3 months
Correlation between Restech acid exposure events and standard pH monitoring acid exposure events.	Using a method similar to the calculation of a symptom index for each study in each patient, to determine the percentage of time in which a Restech-detected acid event occurs at the same time as an acid event detected on standard pH monitoring.	3 months
Laryngoscopic findings pre and post Dexlansoprazole treatment.	Expressed as Reflux Finding Score (RFS).	3 months
Differences between RSI and general GERD symptom questionnaire scores on and off Dexlansoprazole.		3 months
Correlation of RSI and general GERD symptom questionnaire scores with Restecha dn standard pH values.		3 months

Collaborators and Investigators

• Sponsor: University of Washington
• Collaborators: Takeda Pharmaceuticals North America, Inc.
• Investigators: Principal Investigator: Brant K Oelschlager, MD, University of Washington

Study record dates

Study Major Dates

• Study Start: May 1, 2011
• Primary Completion (Anticipated): April 1, 2012
• Study Completion (Anticipated): April 1, 2012

Study Registration Dates

• First Submitted: March 30, 2011
• First Submitted That Met QC Criteria: March 31, 2011
• First Posted (Estimate): April 4, 2011

Study Record Updates

• Last Update Posted (Actual): July 5, 2017
• Last Update Submitted That Met QC Criteria: June 30, 2017
• Last Verified: March 1, 2011

More Information

Terms related to this study

• Keywords: GERD; LPR
• Additional Relevant MeSH Terms: Digestive System Diseases; Respiratory Tract Diseases; Gastrointestinal Diseases; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Laryngeal Diseases; Gastroesophageal Reflux; Laryngopharyngeal Reflux; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Gastrointestinal Agents; Anti-Ulcer Agents; Proton Pump Inhibitors; Dexlansoprazole; Lansoprazole
• Other Study ID Numbers: 39853