Evaluating Treatment Response in Laryngo-Pharyngeal Reflux
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ClinicalTrials.gov Identifier: NCT01328392
Recruitment Status :
(The sponsor did not fund the study.)
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.
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.
Secondary Outcome Measures :
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 ]
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Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Age 18 years old or above
Have a clinical diagnosis of LPR
Able and willing to provide consent
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