Dexlansoprazole to Treat Laryngopharyngeal Reflux and Lingual Tonsil Hypertrophy

NCT01328652 | Unknown Phase 4

• 1 other identifier: 004 10/10
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Laryngopharyngeal Reflux; Hypertrophy of Lingual Tonsil

Keywords

LPR; LTH

Outcome Measures

Primary Outcomes (1)

• Lingual Tonsil Size

  Lingual tonsil tissue size will be measured on computed tomography image at baseline and remeasured following CT imaging after 3 months of proton pump inhibitor therapy.

  3 months

Secondary Outcomes (5)

• Calgary Sleep Apnea Quality of Life Index

  1, 2 and 3 months

• Visual Analog Scale of snoring

  1, 2 and 3 months

• Epworth Sleepiness scale

  1, 2 and 3 months

• Reflux Symptom Index

  1, 2, and 3 months

• Laryngopharyngeal Reflux

  3 months

Study Arms (1)

Proton Pump Inhibitor

EXPERIMENTAL

Treatment with dexlansoprazole 60 mg once daily for 3 months

Drug: dexlansoprazole

Interventions

dexlansoprazole DRUG

dexlansoprazole 60 mg once daily for 3 months

Also known as: proton pump inhibitor, Dexilant

Proton Pump Inhibitor

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Advanced Center for Specialty Care: lead
• Takeda: collaborator

Study Sites (1)

Advanced Center for Specialty Care

Chicago, Illinois, 60657, United States

Location

Related Publications (13)

• 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.

  PMID: 1519566 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.

  PMID: 18359357 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.

  PMID: 10740190 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.

  PMID: 8822724 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.

  PMID: 12737346 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.

  PMID: 16596369 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.

  PMID: 20304271 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.

  PMID: 16890078 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.

  PMID: 18074664 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.

  PMID: 11802013 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.

  PMID: 18722223 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.

  PMID: 15995512 BACKGROUND

MeSH Terms

Conditions

Laryngopharyngeal Reflux

Interventions

Dexlansoprazole; Proton Pump Inhibitors

Condition Hierarchy (Ancestors)

Gastroesophageal Reflux; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Laryngeal Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Lansoprazole; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Michael Friedman, MD

  Head and Neck and Cosmetic Surgery Inc and Advanced Center for Specialty Care

  PRINCIPAL INVESTIGATOR

• Ninos J Joseph, BS

  Advanced Center for Specialty Care

  STUDY DIRECTOR

Central Study Contacts

Michael Friedman, MD

CONTACT

312-236-3642; hednnek@aol.com

Ninos J Joseph, BS

CONTACT

773-294-9376; njoseph@techwritingpartners.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 1, 2011
• First Posted: April 5, 2011
• Study Start: June 1, 2011
• Primary Completion: August 1, 2012
• Study Completion: January 1, 2013
• Last Updated: April 5, 2011

Record last verified: 2011-04

Locations

US (1)