Post-nasal Drainage as an Extraesophageal Manifestation of Reflux
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| ClinicalTrials.gov Identifier: NCT00199953 |
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Recruitment Status :
Completed
First Posted : September 20, 2005
Last Update Posted : January 30, 2017
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Postnasal Drainage | Drug: Rabeprazole 20 mg twice a day for 90-day period treatment | Phase 2 |
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 Type : | Interventional (Clinical Trial) |
| Enrollment : | 50 participants |
| Allocation: | Non-Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double |
| Primary Purpose: | Diagnostic |
| Official Title: | Post-nasal Drainage as an Extraesophageal Manifestation of Reflux |
| Study Start Date : | June 2002 |
| Actual Primary Completion Date : | December 2007 |
| Actual Study Completion Date : | December 2007 |
- - 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.
- - 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.
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| Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00199953
| United States, Wisconsin | |
| Medical College of Wisconsin | |
| Milwaukee, Wisconsin, United States, 53226 | |
| Principal Investigator: | Todd A Loehrl, MD | Medical College of Wisconsin |
| ClinicalTrials.gov Identifier: | NCT00199953 |
| Other Study ID Numbers: |
RAB-USA-57 IRB numbers: FMLH # 02-033 HRRC # 056-02 |
| First Posted: | September 20, 2005 Key Record Dates |
| Last Update Posted: | January 30, 2017 |
| Last Verified: | November 2013 |
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Postnasal drainage Extraesophageal reflux |
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Rabeprazole Anti-Ulcer Agents Gastrointestinal Agents |
Proton Pump Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |