Clinical Trial: Laryngopharyngeal Reflux and Proton Pump Inhibitor (PPI) Treatment
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Identification of Molecular Markers of Inflammatory Mediators in Posterior Laryngitis Due to Laryngopharyngeal Reflux and Evolution With PPI Treatment
Brief 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.
Detailed Summary:
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 = ef
Sponsor: University of Utah
Current 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. [ Time Frame: 3 months ]
Original 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.
Current Secondary Outcome:
Original Secondary Outcome:
Information By: University of Utah
Dates:
Date Received: September 13, 2005
Date Started: August 2003
Date Completion:
Last Updated: January 11, 2008
Last Verified: January 2008
