Post-nasal Drainage as an Extraesophageal Manifestation of Reflux

Phase 2

Completed

• Conditions: Postnasal Drainage

• Registration Number: NCT00199953
• Lead Sponsor: Medical College of Wisconsin

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2002-06
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-12
• Study First Posted: 2005-09-20
• Primary Completion: 2007-12
• Study Completion: 2007-12
• Status Verified: 2013-11
• Last Update Submitted: 2017-01-27
• Last Update Posted: 2017-01-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
- 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 Measures

Name	Time	Method
- 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.

Trial Locations

Locations (1)

Medical College of Wisconsin; 🇺🇸 Milwaukee, Wisconsin, United States