The Study of Eustachian Tube Dysfunction and Laryngopharyngeal Reflux

Eustachian Tube Dysfunction Clinical Trial

— ETDLPR  

Official title:

The Study of the Diagnosis of Eustachian Tube Dysfunction (ETD): Identifying the Relationship of Ear Fullness to Laryngopharyngeal Reflux (LPR)

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02123498
• Other study ID #: ETDLPR2014
• Status: Withdrawn
• Phase: Phase 4
• First received: April 23, 2014
• Last updated: September 22, 2016

Study information

• Verified date: April 2014
• Source: Loma Linda University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Eustachian Tube Dysfunction
• Gastroesophageal Reflux
• Laryngopharyngeal Reflux

Intervention

Drug:
• Omeprazole
40mg, to be taken once daily by mouth, 30-60 minutes before meals, for at least 6 weeks
• Ranitidine
300mg, to be taken once daily by mouth, before bedtime, for at least 6 weeks
• Pantoprazole
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)

Procedure:
• 24-Hour Diagnostic pH-Probe Test
Participants will undergo a routine clinical 24-hour diagnostic pH-probe test to assess quantitative measures for laryngopharyngeal reflux.
• Laryngoscopy
Participants will undergo routine clinical laryngoscopy to assess presence of laryngopharyngeal reflux.

Locations

Country	Name	City	State
United States	11234 Anderson Street	Loma Linda	California
United States	1895 Orange Tree Lane, Suite 102	Redlands	California

Sponsors (1)

Lead Sponsor	Collaborator
Loma Linda University

Country where clinical trial is conducted

United States, 

References & Publications (7)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No