The Study of Eustachian Tube Dysfunction and Laryngopharyngeal Reflux

NCT02123498 | Withdrawn Phase 4 DMC

• 1 other identifier: ETDLPR2014
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is to investigate the relationship between ear fullness, pressure, and/or pain and laryngopharyngeal reflux, in order to focus medical therapy and improve therapeutic outcomes in this patient population.

Conditions

Eustachian Tube Dysfunction; Laryngopharyngeal Reflux

Keywords

ear pressure; ear fullness; ear pain; ETD; laryngopharyngeal reflux; LPR; gastroesophageal reflux disease; GERD; nasopharyngeal reflux; acid reflux

Outcome Measures

Primary Outcomes (1)

• Evidence of laryngopharyngeal reflux in patients complaining of ear fullness/pressure/pain

  Participants complaining of ear pain, ear fullness, or ear pain are diagnosed with laryngopharyngeal reflux via laryngoscope exam and measurement by diagnostic pH-probe test.

  1 year

Study Arms (1)

Single Arm

EXPERIMENTAL

Drug: Omeprazole; Drug: Ranitidine; Drug: Pantoprazole; Procedure: 24-Hour Diagnostic pH-Probe Test; Procedure: Laryngoscopy

Interventions

Omeprazole DRUG

40mg, to be taken once daily by mouth, 30-60 minutes before meals, for at least 6 weeks

Also known as: Prilosec

Single Arm

Ranitidine DRUG

300mg, to be taken once daily by mouth, before bedtime, for at least 6 weeks

Also known as: Zantac

Single Arm

Pantoprazole DRUG

40mg, to be taken twice daily by mouth, 30-60 minutes before meals, for at least 6 weeks. (Alternative intervention if participant cannot tolerate omeprazole, is on an anticoagulant medication, or if on medication contraindicated for omeprazole and ranitidine)

Also known as: Protonix

Single Arm

24-Hour Diagnostic pH-Probe Test PROCEDURE

Participants will undergo a routine clinical 24-hour diagnostic pH-probe test to assess quantitative measures for laryngopharyngeal reflux.

Single Arm

Laryngoscopy PROCEDURE

Participants will undergo routine clinical laryngoscopy to assess presence of laryngopharyngeal reflux.

Single Arm

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• They complain of symptoms of ear fullness, ear pain, and/or ear pressure, either unilateral or bilateral
• They are willing to participate in the study.
• They are between the ages of 18 to 80

You may not qualify if:

• They have had major ear surgery (not including tympanostomy tubes)
• They have a medical condition that is another possible etiology of ear pain or acid reflux and may require additional medical or surgical intervention such as: Acute or chronic otitis externa, Chronic otitis media, Temporomandibular joint dysfunction, Upper aerodigestive track neoplasm, History of head/neck radiation therapy.
• They are pregnant. Proton pump inhibitors are a Category C drug with unknown pregnancy risks.
• They do not wish to participate in the study
• They are \<18 or \>80.

Sponsors & Collaborators

• Loma Linda University: lead

Study Sites (2)

11234 Anderson Street

Loma Linda, California, 92354, United States

Location

1895 Orange Tree Lane, Suite 102

Redlands, California, 92374, United States

Location

Related Publications (7)

• Barbero GJ. Gastroesophageal reflux and upper airway disease. Otolaryngol Clin North Am. 1996 Feb;29(1):27-38.

  PMID: 8834270 BACKGROUND

• Crapko M, Kerschner JE, Syring M, Johnston N. Role of extra-esophageal reflux in chronic otitis media with effusion. Laryngoscope. 2007 Aug;117(8):1419-23. doi: 10.1097/MLG.0b013e318064f177.

  PMID: 17585281 BACKGROUND

• Heavner SB, Hardy SM, White DR, Prazma J, Pillsbury HC 3rd. Transient inflammation and dysfunction of the eustachian tube secondary to multiple exposures of simulated gastroesophageal refluxant. Ann Otol Rhinol Laryngol. 2001 Oct;110(10):928-34. doi: 10.1177/000348940111001007.

  PMID: 11642425 BACKGROUND

• Mims JW. The impact of extra-esophageal reflux upon diseases of the upper respiratory tract. Curr Opin Otolaryngol Head Neck Surg. 2008 Jun;16(3):242-6. doi: 10.1097/MOO.0b013e3282fdc3d6.

  PMID: 18475079 BACKGROUND

• Norman G, Llewellyn A, Harden M, Coatesworth A, Kimberling D, Schilder A, McDaid C. Systematic review of the limited evidence base for treatments of Eustachian tube dysfunction: a health technology assessment. Clin Otolaryngol. 2014 Feb;39(1):6-21. doi: 10.1111/coa.12220.

  PMID: 24438176 BACKGROUND

• Schreiber S, Garten D, Sudhoff H. Pathophysiological mechanisms of extraesophageal reflux in otolaryngeal disorders. Eur Arch Otorhinolaryngol. 2009 Jan;266(1):17-24. doi: 10.1007/s00405-008-0770-1. Epub 2008 Aug 13.

  PMID: 18704479 BACKGROUND

• Yazici ZM, Sari M, Uneri C, Midi A, Tugtepe H. Histologic changes in eustachian tube mucosa of rats after exposure to gastric reflux. Laryngoscope. 2008 May;118(5):849-53. doi: 10.1097/MLG.0b013e318164d0c0.

  PMID: 18300701 BACKGROUND

MeSH Terms

Conditions

Laryngopharyngeal Reflux; Earache; Gastroesophageal Reflux

Interventions

Omeprazole; Ranitidine; Pantoprazole; Laryngoscopy

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Laryngeal Diseases; Respiratory Tract Diseases; Ear Diseases; Otorhinolaryngologic Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Furans; Diagnostic Techniques, Respiratory System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Otorhinolaryngologic Surgical Procedures

Study Officials

• Helen X Xu, MD

  Loma Linda University Otolaryngology Department

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 23, 2014
• First Posted: April 25, 2014
• Primary Completion: May 1, 2015
• Last Updated: September 26, 2016

Record last verified: 2014-04

Locations

US (2)