Clinical trial NCT00199953: Post-nasal Drainage as an Extraesophageal Manifestation of Reflux
Official title: Post-nasal Drainage as an Extraesophageal Manifestation of Reflux
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Postnasal Drainage
Keywords: Postnasal drainage
Extraesophageal reflux
Lead sponsor: Medical College of Wisconsin
Sponsor class: OTHER
Collaborators: name: Ortho-McNeil, Inc.
name: Eisai Inc.
First posted: 2005-09-20
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

Eligibility 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

Primary outcomes:
measure: - VAS1:Visual Analog Scale indicating severity of PND
measure: - VAS2:Visual Analog Scale indicating frequency of PND
measure: - VAS3:Visual Analog Scale indicating frequency of throat-clearing.
Secondary outcomes:
measure: - Two-site 24-hour pH probe test indicating presence or gastroesophageal reflux episodes.
measure: - Videolaryngoscopy for quantitative color analysis evaluation of laryngeal erythema as index of EER.
Other outcomes:
Locations:
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
Study officials:
affiliation: Medical College of Wisconsin
name: Todd A Loehrl, MD
role: PRINCIPAL_INVESTIGATOR
References:
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