Efficacy of Dx-pH Probe in Diagnosing Extra-esophageal Reflux Disease

GERD Clinical Trial

— ADHERE  

Official title:

ADHERE Study: Application of Dx-pH Catheter for Extra-esophageal Reflux Evaluation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00388453
• Other study ID #: 060860
• Status: Completed
• Phase: Phase 3
• First received: October 13, 2006
• Last updated: April 29, 2014
• Start date: October 2006
• Est. completion date: July 2013

Study information

• Verified date: March 2014
• Source: Vanderbilt University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to establish the clinical application of a new device that records pH changes in the hypopharynx. The investigators also aim to compare the consistency of distal esophageal pH with hypopharyngeal pH using both the "short" and the "long" catheters in patients.

Description:

Gastroesophageal reflux disease (GERD) has been linked to many disorders and can be diagnosed through a variety of modalities utilizing 24 hour ambulatory pH monitoring which can register the duration, pattern and symptom correlation of distal esophageal acid exposure. This can be accomplished via a catheter probe connected from outside the body and placed through a nostril, advanced past the hypopharynx and down into the distal esophagus. Or, a small pH detector temporarily implanted in the distal esophagus during endoscopy can record reflux events. However, despite available technologies, there has long been a deficiency in detecting extra-esophageal reflux in the upper esophagus/ hypopharynx. This is of interest for gastroenterologists, otolaryngologists, and pulmonologists in the evaluation of extra-esophageal reflux as a potential culprit for asthma, chronic cough, laryngitis, globus, and non-cardiac chest pain. Until now, there has not been a device sensitive enough for accurately detecting extra-esophageal reflux and clinicians have relied upon subjective response to empiric treatment with acid reducing medications to determine whether acid reflux was at the root of the symptoms. There are currently no well designed published studies with this device to assess its role in this group of difficult to treat patients.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 102
• Est. completion date: July 2013
• Est. primary completion date: September 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

1. Male and female volunteers aged 18 to 65 years old.

2. Control group: No known history of GERD or EERD or prior PPI use.

3. GERD group: Patients with known history of GERD based on prior response to either histamine inhibitors (H2 blockers) or proton pump inhibitors (PPIs) and/or endoscopic esophagitis identified at endoscopy.

4. EERD group: Patients with chronic cough, asthma and laryngeal findings felt to be GERD related.

Exclusion Criteria:

1. Use of H2 blockers or PPIs within one week prior to and during the study for the GERD and EERD patients. No prior PPI use is allowed for the control population.

2. Use of antacids (Rolaids, Tums, Pepto-Bismol, etc.) within one day prior to or during the study.

3. Esophageal motility abnormalities (achalasia, esophageal spasm, severe dysphagia)

4. Expected non-compliance.

5. Positive history of ongoing alcohol or tobacco use and inability to refrain from using either during study duration (24 hours).

6. Recent nasal surgery or nasal obstruction.

7. Significant medical conditions that, in the investigator's judgment, would compromise the subject's health and safety (mental disability, psychiatric impairment, inability to read or comprehend the consent form)

8. Pregnancy

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Gastroesophageal Reflux
• GERD
• Laryngeal Diseases
• Larynx Disease

Intervention

Device:
• Dx-pH Probe
24 hour ph monitoring

Procedure:
• Manometry
procedure to measure LES and UES

Locations

Country	Name	City	State
United States	Vanderbilt Medical Center	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Vanderbilt University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Data from hypopharyngeal and distal esophageal probe after 24 hours		24 hours	Yes
Primary	The distance between short catheter probe in the hypopharynx to the upper esophageal sphincter after 24 hours		24 hours	Yes
Primary	Reflux events of hypopharynx and distal esophagus after 24 hours		24 hours	Yes
Primary	pH data between controls and GERD patients after 24 hours		24 hours	Yes
Primary	Extra-esophageal reflux disease (EERD) patients' symptom improvement at 2 months		24 hours	Yes