Ignite Creation Date:
2024-05-05 @ 11:58 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00199953
Status:
COMPLETED
Last Update Posted:
2017-01-30
First Post:
2005-09-12
Brief Title:
Post-nasal Drainage as an Extraesophageal Manifestation of Reflux
Sponsor:
Medical College of Wisconsin
Organization:
Medical College of Wisconsin
Study Overview
Official Title:
Post-nasal Drainage as an Extraesophageal Manifestation of Reflux
Status:
COMPLETED
Status Verified Date:
2013-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Objectives of this study are
To quantitatively evaluate the relationship between extraesophageal manifestations of gastroesophageal reflux EER and postnasal drainagePNDin 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
To quantitatively evaluate the relationship between extraesophageal manifestations of gastroesophageal reflux EER and postnasal drainagePNDin 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 diseaseGERD is a common disorder of the esophagus affecting 7-10 of the US 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 Reinkes edema subglottic or laryngotracheal stenosis globus pharyngeusand 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 andor 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 2A quantitative color analysis of laryngeal erythema utilizing videolaryngoscopy at days 0 and 90 of treatment
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 andor 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 2A quantitative color analysis of laryngeal erythema utilizing videolaryngoscopy at days 0 and 90 of treatment
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| HRRC 056-02 | None | None | None |
| IRB numbers | None | None | None |
| FMLH 02-033 | None | None | None |