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Post-nasal Drainage as an Extraesophageal Manifestation of Reflux

Перакладаць артыкулы могуць толькі зарэгістраваныя карыстальнікі
Увайсці / Зарэгістравацца
Спасылка захоўваецца ў буферы абмену
СтатусЗавершаны
Спонсары
Medical College of Wisconsin
Калабаранты
Ortho-McNeil, Inc.
Eisai Inc.

Ключавыя словы

Рэферат

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.

Апісанне

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.

Даты

Апошняя праверка: 10/31/2013
Упершыню прадстаўлена: 09/11/2005
Меркаваная колькасць заявак прадстаўлена: 09/11/2005
Першае паведамленне: 09/19/2005
Апошняе абнаўленне адпраўлена: 01/26/2017
Апошняе абнаўленне апублікавана: 01/29/2017
Фактычная дата пачатку даследавання: 05/31/2002
Разліковая дата першаснага завяршэння: 11/30/2007
Разліковая дата завяршэння даследавання: 11/30/2007

Стан альбо хвароба

Postnasal Drainage

Ўмяшанне / лячэнне

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

Фаза

Фаза 2

Крытэрыі прыдатнасці

Узрост, які мае права на вучобу 18 Years Каб 18 Years
Пол, прыдатны для навучанняAll
Прымае здаровых валанцёраўТак
Крытэрыі

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

Вынік

Першасныя вынікі

1. - VAS1:Visual Analog Scale indicating severity of PND [undefined]

2. - VAS2:Visual Analog Scale indicating frequency of PND [undefined]

3. - VAS3:Visual Analog Scale indicating frequency of throat-clearing. [undefined]

Меры другаснага выніку

1. - Two-site 24-hour pH probe test indicating presence or gastroesophageal reflux episodes. [undefined]

2. - Videolaryngoscopy for quantitative color analysis evaluation of laryngeal erythema as index of EER. [undefined]

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