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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Michael Vaezi, Vanderbilt University
ClinicalTrials.gov Identifier:
NCT00388453
First received: October 13, 2006
Last updated: April 29, 2014
Last verified: March 2014

October 13, 2006
April 29, 2014
October 2006
September 2012   (final data collection date for primary outcome measure)
  • Data from hypopharyngeal and distal esophageal probe after 24 hours [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]
  • The distance between short catheter probe in the hypopharynx to the upper esophageal sphincter after 24 hours [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]
  • Reflux events of hypopharynx and distal esophagus after 24 hours [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]
  • pH data between controls and GERD patients after 24 hours [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]
  • Extra-esophageal reflux disease (EERD) patients' symptom improvement at 2 months [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]
  • Data from hypopharyngeal and distal esophageal probe after 24 hours
  • The distance between short catheter probe in the hypopharynx to the upper esophageal sphincter after 24 hours
  • Reflux events of hypopharynx and distal esophagus after 24 hours
  • pH data between controls and GERD patients after 24 hours
  • EERD patients' symptom improvement at 2 months
Complete list of historical versions of study NCT00388453 on ClinicalTrials.gov Archive Site
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Efficacy of Dx-pH Probe in Diagnosing Extra-esophageal Reflux Disease
ADHERE Study: Application of Dx-pH Catheter for Extra-esophageal Reflux Evaluation

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.

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.

Interventional
Phase 3
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
  • GERD
  • Larynx Disease
  • Device: Dx-pH Probe
    24 hour ph monitoring
  • Procedure: Manometry
    procedure to measure LES and UES
  • Active Comparator: 1
    Healthy volunteers with no history of GERD or EERD or PPI use
    Interventions:
    • Device: Dx-pH Probe
    • Procedure: Manometry
  • Experimental: 2
    subject is known to have GERD based on symptoms and previous positive response to PPI
    Interventions:
    • Device: Dx-pH Probe
    • Procedure: Manometry
  • Experimental: 3
    subject is known to have EERD based on symptoms and previous positive response to PPI
    Interventions:
    • Device: Dx-pH Probe
    • Procedure: Manometry
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
102
July 2013
September 2012   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00388453
060860
No
Michael Vaezi, Vanderbilt University
Vanderbilt University
Not Provided
Principal Investigator: Michael F Vaezi, MD, PhD, MS Vanderbilt University
Vanderbilt University
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP