Post-nasal Drainage as an Extraesophageal Manifestation of Reflux
Condition: Postnasal Drainage
Study type: Interventional
Phase: Phase 2

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.
    

Intervention name(s): Rabeprazole 20 mg twice a day for 90-day period treatment
Intervention type(s): Drug
Intervention MeSH terms: Rabeprazole
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Diagnostic
Keywords: Postnasal drainage; Extraesophageal reflux