Evaluating Treatment Response in Laryngo-Pharyngeal Reflux
Recruitment status was Not yet recruiting
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 Design:||Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Evaluating Treatment Response in Laryngo-Pharyngeal Reflux|
- Ability of Restech to predict LPR symptom improvement after treatment with Dexlansoprazole. [ Time Frame: 3 months ] [ Designated as safety issue: No ]Successful LPR symptom improvement will be defined as a 25% improvement in Reflux Symptom Index (RSI)after 3 months of Dexlansoprazole.
- Comparison between standard pH data and Restech data (normal vs.abnormal acid exposure, using established normative data values) before and after treatment with Dexlansoprazole. [ Time Frame: 3 months ] [ Designated as safety issue: No ]
- Correlation between Restech acid exposure events and standard pH monitoring acid exposure events. [ Time Frame: 3 months ] [ Designated as safety issue: No ]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.
- Laryngoscopic findings pre and post Dexlansoprazole treatment. [ Time Frame: 3 months ] [ Designated as safety issue: No ]Expressed as Reflux Finding Score (RFS).
- Differences between RSI and general GERD symptom questionnaire scores on and off Dexlansoprazole. [ Time Frame: 3 months ] [ Designated as safety issue: No ]
- Correlation of RSI and general GERD symptom questionnaire scores with Restecha dn standard pH values. [ Time Frame: 3 months ] [ Designated as safety issue: No ]
|Study Start Date:||May 2011|
|Estimated Study Completion Date:||April 2012|
|Estimated Primary Completion Date:||April 2012 (Final data collection date for primary outcome measure)|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01328392
|Contact: Brant K Oelschalger, MDfirstname.lastname@example.org|
|United States, Washington|
|University of Washington||Not yet recruiting|
|Seattle, Washington, United States, 98105|
|Contact: Brant K Oelschlager, MD 206-543-3518 email@example.com|
|Principal Investigator: Brant K Oelschlager, MD|
|Principal Investigator:||Brant K Oelschlager, MD||University of Washington|