Dexlansoprazole to Treat Laryngopharyngeal Reflux and Lingual Tonsil Hypertrophy

• Status: Unknown status
• Trial end date: 2013-01-01
• Target enrollment: 0
• Participant gender: All

Summary

Main Hypothesis: The investigators hypothesize that measurements of lingual tonsil tissue (LTT) thickness will decrease following treatment with once daily oral dexlansoprazole 60 mg in patients diagnosed with laryngopharyngeal reflux (LPR) and lingual tonsil hypertrophy (LTH) compared to matched controls receiving placebo.

Primary endpoints include:

• 24-hour oropharyngeal pH testing, pre- and post-treatment

• Mean lingual tonsil tissue (LTT) thickness, pre- and post-treatment, as determined by CT scan of the base of tongue

Secondary endpoints include:

• Reflux Finding Score (RFS) on pre- and post-treatment endoscopy of the oropharynx

• Subjective outcome metrics for assessing LPR-related symptoms and associated quality of life

• Calgary Sleep Apnea Quality of Life Index

• Bed-partner assessment of snoring intensity according to a Visual Analog Scale

• Epworth Sleepiness Scale (ESS)

• Reflux Symptom Index (RSI)

Specific Aims: The primary objective of this study is to determine whether treatment of patients diagnosed with LPR and LTH with 3 months of PPI therapy reduces LTT thickness, as measured on CT scan of the tongue base.

The secondary objectives of this study are to:

• Evaluate changes in LPR-related symptoms and quality of life after therapy using the following subjective outcome metrics:

• Calgary Sleep Apnea Quality of Life Index

• Bed-partner assessment of snoring intensity according to a Visual Analog Scale

• Epworth Sleepiness Scale

• Reflux symptom index

• Correlate changes in LTT thickness with the following secondary endpoints:

• Changes in the above subjective outcome metrics

• Changes in endoscopic findings of LPR

• Changes in 24-hour oropharyngeal pH study results

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Advanced Center for Specialty Care
• Collaborator: Takeda
• Treatments: Dexlansoprazole; Lansoprazole; Proton Pump Inhibitors

Criteria

Inclusion Criteria:

• Diagnosis of LPR and LTH confirmed by 24-hour pharyngeal pH monitoring and CT of the tongue base, respectively

• Age > 20 and < 60 years

• Failure (in the opinion of the patient and treating physician) of current treatment regimen and willingness (by the patient) to discontinue all concurrent therapies for LPR whether prescription, over-the-counter, or herbal, and to remain off of these treatments for the entire course of the study

Exclusion Criteria:

• Pregnancy or anticipated pregnancy (confirmation of non-pregnant status will be made by urine human chorionic gonadotropin level)

• Lactation

• History or diagnosis of moderate to severe hepatic disease (based on liver function testing performed at screening adjusted for age, gender, race, concomitant medications and comorbidities

• Current or within the previous (12 mo) usage of a proton pump inhibitor

• Concurrent use of any medications, which interact adversely with dexlansoprazole or other proton pump inhibitors (e.g., penicillins, digoxin, iron salts, azole antifungals, atazanavir, tacrolimus, clopidogrel, etc.)

• Allergy or sensitivity to dexlansoprazole (or other proton pump inhibitor) or cimetidine (or other H2 blocker)

• History of laryngeal and/or pharyngeal surgery

• Preexisting voice or swallowing disorder not related to LPR

• Smoking

• Neoplastic or infectious processes that are systemic or localized to the head and neck region