Postnasal Drainage Clinical Trial
Official title:
Post-nasal Drainage as an Extraesophageal Manifestation of Reflux
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.
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.
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