Dexlansoprazole to Treat Laryngopharyngeal Reflux and Lingual Tonsil Hypertrophy - Full Text View

Purpose

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

Condition	Intervention	Phase
Laryngopharyngeal Reflux Hypertrophy of Lingual Tonsil	Drug: dexlansoprazole	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	A Randomized, Double-blind, Placebo-controlled Study of Dexlansoprazole to Treat Laryngopharyngeal Reflux and Lingual Tonsil Hypertrophy

Resource links provided by NLM:

MedlinePlus related topics: GERD Sleep Apnea Snoring Tonsils and Adenoids

Drug Information available for: Lansoprazole Dexlansoprazole

U.S. FDA Resources

Further study details as provided by Advanced Center for Specialty Care:

Primary Outcome Measures:

Lingual Tonsil Size [ Time Frame: 3 months ] [ Designated as safety issue: No ]
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.

Secondary Outcome Measures:

Calgary Sleep Apnea Quality of Life Index [ Time Frame: 1, 2 and 3 months ] [ Designated as safety issue: No ]
Calgary Sleep Apnea Quality of Life Index measures the quality of life in sleep apnea patients.
Visual Analog Scale of snoring [ Time Frame: 1, 2 and 3 months ] [ Designated as safety issue: No ]
Visual Analog Scale of snoring measures the loudness and disturbance factor related to snoring as documented by the bedpartner (when available)
Epworth Sleepiness scale [ Time Frame: 1, 2 and 3 months ] [ Designated as safety issue: No ]
Epworth Sleepiness scale measures the daytime sleepiness caused by sleep disturbances and interruptions associated with sleep apnea or snoring.
Reflux Symptom Index [ Time Frame: 1, 2, and 3 months ] [ Designated as safety issue: Yes ]
Reflux Symptom Index monitrors the physical signs and symptoms of laryngopharyngeal reflux during treatment obtained during fiberoptic endoscopy of the larynx, pharynx and esophagus.
Laryngopharyngeal Reflux [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
Continuous 24 hour laryngopharyngeal pH monitoring

Estimated Enrollment:	80
Study Start Date:	June 2011
Estimated Study Completion Date:	January 2013
Estimated Primary Completion Date:	August 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Proton Pump Inhibitor Treatment with dexlansoprazole 60 mg once daily for 3 months	Drug: dexlansoprazole dexlansoprazole 60 mg once daily for 3 months Other Names: dexlansoprazole proton pump inhibitor Dexilant

Show Detailed Description

Eligibility

Ages Eligible for Study:	18 Years to 59 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01328652

Contacts

Contact: Michael Friedman, MD	312-236-3642	hednnek@aol.com
Contact: Ninos J Joseph, BS	773-294-9376	njoseph@techwritingpartners.com

Locations

United States, Illinois
Advanced Center for Specialty Care	Not yet recruiting
Chicago, Illinois, United States, 60657
Principal Investigator: Michael Friedman, MD

Sponsors and Collaborators

Advanced Center for Specialty Care

Takeda Global Research & Development Center, Inc.

Investigators

Principal Investigator:	Michael Friedman, MD	Head and Neck and Cosmetic Surgery Inc and Advanced Center for Specialty Care
Study Director:	Ninos J Joseph, BS	Advanced Center for Specialty Care

More Information

Publications:

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.

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.

Mamede RC, De Mello-Filho FV, Vigário 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.

Dündar A, Ozünlü A, Sahan M, Ozgen F. Lingual tonsil hypertrophy producing obstructive sleep apnea. Laryngoscope. 1996 Sep;106(9 Pt 1):1167-9.

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.

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. Epub 2006 Apr 5.

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.

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.

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.

Senior BA, Khan M, Schwimmer C, Rosenthal L, Benninger M. Gastroesophageal reflux and obstructive sleep apnea. Laryngoscope. 2001 Dec;111(12):2144-6.

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.

Reichel O, Dressel H, Wiederänders 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.

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.

Responsible Party:	Michael Friedman, MD, Head and Neck and Cosmetic Surgery, Inc.and Advanced Center for Specialty Care
ClinicalTrials.gov Identifier:	NCT01328652 History of Changes
Other Study ID Numbers:	004 10/10
Study First Received:	April 1, 2011
Last Updated:	April 4, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by Advanced Center for Specialty Care:

LPR
LTH

Additional relevant MeSH terms:

Gastroesophageal Reflux
Hypertrophy
Regurgitation, Gastric
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Pathological Conditions, Anatomical

Lansoprazole
Proton Pump Inhibitors
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Ulcer Agents
Gastrointestinal Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 21, 2013