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The Study of Eustachian Tube Dysfunction and Laryngopharyngeal Reflux (ETDLPR)

Primary Purpose

Eustachian Tube Dysfunction, Laryngopharyngeal Reflux

Status
Withdrawn
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Omeprazole
Ranitidine
Pantoprazole
24-Hour Diagnostic pH-Probe Test
Laryngoscopy
Sponsored by
Loma Linda University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Eustachian Tube Dysfunction focused on measuring ear pressure, ear fullness, ear pain, ETD, laryngopharyngeal reflux, LPR, gastroesophageal reflux disease, GERD, nasopharyngeal reflux, acid reflux

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Sites / Locations

  • 11234 Anderson Street
  • 1895 Orange Tree Lane, Suite 102

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Single Arm

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
April 23, 2014
Last Updated
September 22, 2016
Sponsor
Loma Linda University
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1. Study Identification

Unique Protocol Identification Number
NCT02123498
Brief Title
The Study of Eustachian Tube Dysfunction and Laryngopharyngeal Reflux
Acronym
ETDLPR
Official Title
The Study of the Diagnosis of Eustachian Tube Dysfunction (ETD): Identifying the Relationship of Ear Fullness to Laryngopharyngeal Reflux (LPR)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2014
Overall Recruitment Status
Withdrawn
Why Stopped
IRB not approved
Study Start Date
undefined (undefined)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Loma Linda University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Eustachian Tube Dysfunction, Laryngopharyngeal Reflux
Keywords
ear pressure, ear fullness, ear pain, ETD, laryngopharyngeal reflux, LPR, gastroesophageal reflux disease, GERD, nasopharyngeal reflux, acid reflux

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Single Arm
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Omeprazole
Other Intervention Name(s)
Prilosec
Intervention Description
40mg, to be taken once daily by mouth, 30-60 minutes before meals, for at least 6 weeks
Intervention Type
Drug
Intervention Name(s)
Ranitidine
Other Intervention Name(s)
Zantac
Intervention Description
300mg, to be taken once daily by mouth, before bedtime, for at least 6 weeks
Intervention Type
Drug
Intervention Name(s)
Pantoprazole
Other Intervention Name(s)
Protonix
Intervention Description
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)
Intervention Type
Procedure
Intervention Name(s)
24-Hour Diagnostic pH-Probe Test
Intervention Description
Participants will undergo a routine clinical 24-hour diagnostic pH-probe test to assess quantitative measures for laryngopharyngeal reflux.
Intervention Type
Procedure
Intervention Name(s)
Laryngoscopy
Intervention Description
Participants will undergo routine clinical laryngoscopy to assess presence of laryngopharyngeal reflux.
Primary Outcome Measure Information:
Title
Evidence of laryngopharyngeal reflux in patients complaining of ear fullness/pressure/pain
Description
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.
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Helen X Xu, MD
Organizational Affiliation
Loma Linda University Otolaryngology Department
Official's Role
Principal Investigator
Facility Information:
Facility Name
11234 Anderson Street
City
Loma Linda
State/Province
California
ZIP/Postal Code
92354
Country
United States
Facility Name
1895 Orange Tree Lane, Suite 102
City
Redlands
State/Province
California
ZIP/Postal Code
92374
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
8834270
Citation
Barbero GJ. Gastroesophageal reflux and upper airway disease. Otolaryngol Clin North Am. 1996 Feb;29(1):27-38.
Results Reference
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PubMed Identifier
17585281
Citation
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.
Results Reference
background
PubMed Identifier
11642425
Citation
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.
Results Reference
background
PubMed Identifier
18475079
Citation
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.
Results Reference
background
PubMed Identifier
24438176
Citation
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.
Results Reference
background
PubMed Identifier
18704479
Citation
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.
Results Reference
background
PubMed Identifier
18300701
Citation
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.
Results Reference
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The Study of Eustachian Tube Dysfunction and Laryngopharyngeal Reflux

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