NCT02123498 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

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

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

Clinical trial NCT02123498 - References