Laryngopharyngeal Reflux and Proton Pump Inhibitor (PPI) Treatment

Utah System of Higher Education (USHE)

Status and phase: Completed; Phase 3; Phase 2

Conditions: Laryngopharyngeal Reflux

Treatments: Drug: Aciphex

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00204698

IRB 11690

Details and patient eligibility

About

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.

Full 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.

Enrollment: 24 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• The subject group will consist of 25 subjects who have untreated LPR diagnosed by laryngoscopic assessment and 24-hour pH probe.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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24 participants in 1 patient group

1

Active Comparator group

Description:

All subjects will be given active drug.

Treatment:

Drug: Aciphex