Laryngopharyngeal Reflux and Proton Pump Inhibitor (PPI) Treatment
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.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Identification of Molecular Markers of Inflammatory Mediators in Posterior Laryngitis Due to Laryngopharyngeal Reflux and Evolution With PPI Treatment|
- 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. [ Time Frame: 3 months ] [ Designated as safety issue: No ]
|Study Start Date:||August 2003|
|Study Completion Date:||May 2006|
|Primary Completion Date:||May 2006 (Final data collection date for primary outcome measure)|
Active Comparator: 1
All subjects will be given active drug.
20 mg of aciphex taken twice daily
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00204698
|United States, Utah|
|University of Utah|
|Salt Lake City, Utah, United States, 84132|
|Principal Investigator:||Susan Thibeault, Ph.D.||University of Utah|