Clinical Trial: Evaluating Treatment Response in Laryngo-Pharyngeal Reflux

Study Status: Recruiting
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Evaluating Treatment Response in Laryngo-Pharyngeal Reflux

Brief Summary: 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.

Detailed Summary:
Sponsor: University of Washington

Current Primary Outcome: Ability of Restech to predict LPR symptom improvement after treatment with Dexlansoprazole. [ Time Frame: 3 months ]

Successful LPR symptom improvement will be defined as a 25% improvement in Reflux Symptom Index (RSI)after 3 months of Dexlansoprazole.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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 ]
  • Correlation between Restech acid exposure events and standard pH monitoring acid exposure events. [ Time Frame: 3 months ]
    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 ]
    Expressed as Reflux Finding Score (RFS).
  • Differences between RSI and general GERD symptom questionnaire scores on and off Dexlansoprazole. [ Time Frame: 3 months ]
  • Correlation of RSI and general GERD symptom questionnaire scores with Restecha dn standard pH values. [ Time Frame: 3 months ]


Original Secondary Outcome: Same as current

Information By: University of Washington

Dates:
Date Received: March 30, 2011
Date Started: May 2011
Date Completion: April 2012
Last Updated: March 31, 2011
Last Verified: March 2011