Post-nasal Drainage as an Extraesophageal Manifestation of Reflux

Postnasal Drainage Clinical Trial

Official title:

Post-nasal Drainage as an Extraesophageal Manifestation of Reflux

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00199953
• Other study ID #: RAB-USA-57
• Secondary ID: IRB numbers:FMLH
• Status: Completed
• Phase: Phase 2
• First received: September 12, 2005
• Last updated: January 27, 2017
• Start date: June 2002
• Est. completion date: December 2007

Study information

• Verified date: November 2013
• Source: Medical College of Wisconsin
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Objectives of this study are:

• To quantitatively evaluate the relationship between extraesophageal manifestations of gastroesophageal reflux (EER) and postnasal drainage(PND)in a group of patients without radiographic or endoscopic evidence of sinonasal inflammatory disease.

• To assess the efficacy of BID proton pump inhibitors (PPI) in the management of patients with symptomatic postnasal drainage.

Description:

Gastroesophageal reflux disease(GERD) is a common disorder of the esophagus, affecting 7-10% of the U.S. population. Characteristic symptoms include heartburn, chest pain, and indigestion. EER denotes gastroesophageal refluxate that reaches structures above the upper esophageal sphincter. EER has been implicated in the pathogenesis of several otolaryngologic disorders such as chronic posterior laryngitis, laryngeal contact ulcer or granuloma, paroxysmal laryngospasm, vocal cord nodules, Reinke's edema, subglottic or laryngotracheal stenosis, globus pharyngeus,and laryngeal and hypopharyngeal carcinoma. In addition, EER has been associated with disorders of both the lower and upper respiratory tract and with chronic sinonasal inflammation.

Patients with EER rarely complain of the common symptoms of GERD, such as heartburn. Often they present with symptoms involving the larynx and pharynx, including throat-clearing, globus pharyngeus, and postnasal drainage. These symptoms may be present due to direct irritation of the nasal epithelium by gastric refluxate and/or a neurogenic inflammatory process mediated by the autonomic nervous system.

Specific Aims:

• Specific Aim 1: To establish the relation ship between EER and PND in patients without sinonasal inflammatory disease.

• Hypothesis 1: In patients without radiographic or endoscopic evidence of sinonasal inflammatory disease, PND is a symptom of EER.

• Method 1: We will test this hypothesis utilizing a 2-site 24-hour pH probe test in a symptomatic patient group and compare then to a previously tested age and sex-matched control group.

• Specific Aim 2: To establish the efficacy of PPI in the management of PND.

• Hypothesis 2: Patients with a chief complaint of PND and no sinonasal inflammatory disease will improve with 3-month PPI treatment with Rabeprazole 20 mg twice a day.

• Method 2: A group of patients with a chief complaint of postnasal drainage, without radiographic or endoscopic evidence of sinonasal inflammatory disease will be entered into a prospective placebo-controlled trial utilizing BID PPIs over a 3-month period. the primary outcome measures will be: 1) Visual analog Scales, assessing the severity and frequency of PND at days 0 and 90 of treatment and 2)A quantitative color analysis of laryngeal erythema, utilizing videolaryngoscopy at days 0 and 90 of treatment.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 2007
• Est. primary completion date: December 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Age >18 and <70;

• PND as chief complaint;

• No known acute or chronic sinus disease;

• Nonsmokers;

• Subjects with no history of esophageal or gastric surgery

• Subjects with no history of allergic disease

• Women non pregnant.

Exclusion Criteria:

• Age , 18 or > 70;

• No PND as chief complaint

• Al;ergic disease or acute or chronic sinus disease;

• Smokers;

• Pregnant women;

• Subjects with history of esophageal or gastric surgery

Related Conditions & MeSH terms

• Postnasal Drainage

Intervention

Drug:
• Rabeprazole 20 mg twice a day for 90-day period treatment

Locations

Country	Name	City	State
United States	Medical College of Wisconsin	Milwaukee	Wisconsin

Sponsors (3)

Lead Sponsor	Collaborator
Medical College of Wisconsin	Eisai Inc., Ortho-McNeil, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (9)

Chambers DW, Davis WE, Cook PR, Nishioka GJ, Rudman DT. Long-term outcome analysis of functional endoscopic sinus surgery: correlation of symptoms with endoscopic examination findings and potential prognostic variables. Laryngoscope. 1997 Apr;107(4):504-10. — View Citation

El-Serag HB, Lee P, Buchner A, Inadomi JM, Gavin M, McCarthy DM. Lansoprazole treatment of patients with chronic idiopathic laryngitis: a placebo-controlled trial. Am J Gastroenterol. 2001 Apr;96(4):979-83. — View Citation

Hanson DG, Jiang J, Chi W. Quantitative color analysis of laryngeal erythema in chronic posterior laryngitis. J Voice. 1998 Mar;12(1):78-83. — View Citation

Jaradeh SS, Smith TL, Torrico L, Prieto TE, Loehrl TA, Darling RJ, Toohill RJ. Autonomic nervous system evaluation of patients with vasomotor rhinitis. Laryngoscope. 2000 Nov;110(11):1828-31. — View Citation

Lodi U, Harding SM, Coghlan HC, Guzzo MR, Walker LH. Autonomic regulation in asthmatics with gastroesophageal reflux. Chest. 1997 Jan;111(1):65-70. — View Citation

Smit CF, Tan J, Devriese PP, Mathus-Vliegen LM, Brandsen M, Schouwenburg PF. Ambulatory pH measurements at the upper esophageal sphincter. Laryngoscope. 1998 Feb;108(2):299-302. — View Citation

Smith TL, Correa AJ, Kuo T, Reinisch L. Radiofrequency tissue ablation of the inferior turbinates using a thermocouple feedback electrode. Laryngoscope. 1999 Nov;109(11):1760-5. — View Citation

Ulualp SO, Toohill RJ, Hoffmann R, Shaker R. Possible relationship of gastroesophagopharyngeal acid reflux with pathogenesis of chronic sinusitis. Am J Rhinol. 1999 May-Jun;13(3):197-202. — View Citation

Ulualp SO, Toohill RJ. Laryngopharyngeal reflux: state of the art diagnosis and treatment. Otolaryngol Clin North Am. 2000 Aug;33(4):785-802. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	- VAS1:Visual Analog Scale indicating severity of PND
Primary	- VAS2:Visual Analog Scale indicating frequency of PND
Primary	- VAS3:Visual Analog Scale indicating frequency of throat-clearing.
Secondary	- Two-site 24-hour pH probe test indicating presence or gastroesophageal reflux episodes.
Secondary	- Videolaryngoscopy for quantitative color analysis evaluation of laryngeal erythema as index of EER.