Dexlansoprazole to Treat Laryngopharyngeal Reflux and Lingual Tonsil Hypertrophy

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

Timeline

Start

2011-06

Primary completion

2012-08

Completion

2013-01

Publications

• Background Jamieson JR, Stein HJ, DeMeester TR, Bonavina L, Schwizer W, Hinder RA, Albertucci M. Ambulatory 24-h esophageal pH monitoring: normal values, optimal thresholds, specificity, sensitivity, and reproducibility. Am J Gastroenterol. 1992 Sep;87(9):1102-11.
• Background DelGaudio JM, Naseri I, Wise JC. Proximal pharyngeal reflux correlates with increasing severity of lingual tonsil hypertrophy. Otolaryngol Head Neck Surg. 2008 Apr;138(4):473-8. doi: 10.1016/j.otohns.2007.12.023.
• Background Mamede RC, De Mello-Filho FV, Vigario LC, Dantas RO. Effect of gastroesophageal reflux on hypertrophy of the base of the tongue. Otolaryngol Head Neck Surg. 2000 Apr;122(4):607-10. doi: 10.1067/mhn.2000.98362.
• Background Dundar A, Ozunlu A, Sahan M, Ozgen F. Lingual tonsil hypertrophy producing obstructive sleep apnea. Laryngoscope. 1996 Sep;106(9 Pt 1):1167-9. doi: 10.1097/00005537-199609000-00022.
• Background Suzuki K, Kawakatsu K, Hattori C, Hattori H, Nishimura Y, Yonekura A, Yagisawa M, Nishimura T. Application of lingual tonsillectomy to sleep apnea syndrome involving lingual tonsils. Acta Otolaryngol Suppl. 2003;(550):65-71. doi: 10.1080/0365523031000057.
• Background Fricke BL, Donnelly LF, Shott SR, Kalra M, Poe SA, Chini BA, Amin RS. Comparison of lingual tonsil size as depicted on MR imaging between children with obstructive sleep apnea despite previous tonsillectomy and adenoidectomy and normal controls. Pediatr Radiol. 2006 Jun;36(6):518-23. doi: 10.1007/s00247-006-0149-7. Epub 2006 Apr 5.
• Background Friedman M, Wilson MN, Pulver TM, Golbin D, Lee GP, Gorelick G, Joseph NJ. Measurements of adult lingual tonsil tissue in health and disease. Otolaryngol Head Neck Surg. 2010 Apr;142(4):520-5. doi: 10.1016/j.otohns.2009.12.036.
• Background Wise SK, Wise JC, DelGaudio JM. Gastroesophageal reflux and laryngopharyngeal reflux in patients with sleep-disordered breathing. Otolaryngol Head Neck Surg. 2006 Aug;135(2):253-7. doi: 10.1016/j.otohns.2006.05.012.
• Background Friedman M, Gurpinar B, Lin HC, Schalch P, Joseph NJ. Impact of treatment of gastroesophageal reflux on obstructive sleep apnea-hypopnea syndrome. Ann Otol Rhinol Laryngol. 2007 Nov;116(11):805-11. doi: 10.1177/000348940711601103.
• Background Senior BA, Khan M, Schwimmer C, Rosenthal L, Benninger M. Gastroesophageal reflux and obstructive sleep apnea. Laryngoscope. 2001 Dec;111(12):2144-6. doi: 10.1097/00005537-200112000-00012.
• Background Farrokhi F, Hill EM, Sun G, et al. Dx-pH Monitoring: how does it compare to the standard pH probe? Am J Gastroenterol 2007;103:S2.
• Background Reichel O, Dressel H, Wiederanders K, Issing WJ. Double-blind, placebo-controlled trial with esomeprazole for symptoms and signs associated with laryngopharyngeal reflux. Otolaryngol Head Neck Surg. 2008 Sep;139(3):414-20. doi: 10.1016/j.otohns.2008.06.003.
• Background Park W, Hicks DM, Khandwala F, Richter JE, Abelson TI, Milstein C, Vaezi MF. Laryngopharyngeal reflux: prospective cohort study evaluating optimal dose of proton-pump inhibitor therapy and pretherapy predictors of response. Laryngoscope. 2005 Jul;115(7):1230-8. doi: 10.1097/01.MLG.0000163746.81766.45.

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