Laryngopharyngeal Reflux and Proton Pump Inhibitor (PPI) Treatment
Information source: University of Utah
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Laryngopharyngeal Reflux
Intervention: Aciphex (Drug)
Phase: Phase 2/Phase 3
Status: Completed
Sponsored by: University of Utah Official(s) and/or principal investigator(s):
Susan Thibeault, Ph.D., Principal Investigator, Affiliation: University of Utah
Summary
This study proposes to investigate prospectively, the presence of molecular markers for
inflammation in laryngopharyngeal reflux (LPR) patients and to study the effect of a proton
pump inhibitor (Aciphex) on these molecular markers.
The investigators will be evaluating a group of patients before and after treatment. This
group will be patients that have untreated laryngopharyngeal reflux diagnosed by
laryngoscopic assessment and a 24-hour probe.
Clinical Details
Official title: Identification of Molecular Markers of Inflammatory Mediators in Posterior Laryngitis Due to Laryngopharyngeal Reflux and Evolution With PPI Treatment
Study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Primary outcome: The presence of proinflammatory cytokines will be measured at the gene and protein expression levels from PL biopsies with gene specific semiquantitative reverse transcription-polymerase chain reaction and western blot analysis.
Detailed description:
Objectives:
This study proposes to investigate prospectively, the presence of molecular markers for
inflammation in LPR patients and to study the effect of a proton pump inhibitor on these
molecular markers. This study will provide important data regarding the etiology of LPR. It
will also provide vital information about the present standard treatment for LPR and why it
is not universally successful.
Patient Selection Criteria:
The subject group will consist of 25 subjects who have untreated LPR diagnosed by
laryngoscopic assessment and 24-hour pH probe.
Design:
The presence of proinflammatory cytokines will be measured at the gene and protein expression
levels from PL biopsies with gene specific semiquantitative reverse transcription-polymerase
chain reaction and Western Blot analysis.
Statistical Methods, Data Analysis, and Interpretation:
Null Hypothesis: There will be no difference in cytokine expression in the posterior larynx
in patients with laryngopharyngeal reflux after 10 weeks of treatment with Aciphex, a proton
pump inhibitor.
Alternative Hypothesis: There will be a difference in cytokine expression in the posterior
larynx in patients with laryngopharyngeal reflux after 10 weeks of treatment with Aciphex, a
proton pump inhibitor.
Effect size = 30% (based upon review of the literature for cytokines in inflammatory states)
Standard Deviation = 30
Standard Effect Size = effect size/standard deviation = 30/30 = 1
With an alpha of 0. 05, power 0. 1 (90% power), sample size should be 22. Therefore we have
chosen 25 subjects in case of error in molecular studies.
Paired t-tests will be utilized to compare differences between cytokine levels for
experimental group initiation and completion of medication.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- The subject group will consist of 25 subjects who have untreated LPR diagnosed by
laryngoscopic assessment and 24-hour pH probe.
Locations and Contacts
University of Utah, Salt Lake City, Utah 84132, United States
Additional Information
Starting date: August 2003
Ending date: May 2006
Last updated: January 11, 2008
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