Post-Nasal Drainage as an Extraesophageal Manifestation of Reflux

Condition(s) targeted: - Postnasal Drainage

Intervention: Rabeprazole 20 mg twice a day for 90-day period treatment (Drug)

Phase: Phase 2

Status: Active, not recruiting

Sponsored by: Medical College of Wisconsin

Official(s) and/or principal investigator(s):
Todd A Loehrl, MD, Principal Investigator, Affiliation: Medical College of Wisconsin

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.

Official title: Post-Nasal Drainage as an Extraesophageal Manifestation of Reflux

Study design: Diagnostic, Non-Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome:

- VAS1:Visual Analog Scale indicating severity of PND

- VAS2:Visual Analog Scale indicating frequency of PND

- VAS3:Visual Analog Scale indicating frequency of throat-clearing.

Secondary outcome:

- Two-site 24-hour pH probe test indicating presence or gastroesophageal reflux episodes.

- Videolaryngoscopy for quantitative color analysis evaluation of laryngeal erythema as index of EER.

Detailed description: Gastroesophageal reflux disease(GERD) is a common disorder of the esophagus, affecting 7-10% of the U. S. population. Characteristicx 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.

Minimum age: 18 Years. Maximum age: 70 Years. Gender(s): Both.

Criteria:

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

Medical College of Wisconsin, Milwaukee, Wisconsin 53226, United States

Related publications:

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

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

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.

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.

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.

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. No abstract available.

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

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.

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.

Starting date: June 2002
Ending date: March 2005
Last updated: September 12, 2005