Study of an Oropharyngeal Aerosolized pH Probe for Diagnosing Laryngopharyngeal Reflux (LPR)

This study has been completed.
Sponsor:
Collaborators:
AstraZeneca
Respiratory Technology Corporation
Information provided by (Responsible Party):
Adam Klein, Emory University
ClinicalTrials.gov Identifier:
NCT00321503
First received: May 2, 2006
Last updated: December 6, 2013
Last verified: December 2013
  Purpose

This study is a test of how well a new FDA-approved device is for diagnosing a condition known as laryngopharyngeal reflux (LPR). The device, which measures pH of the air in the upper throat, will be compared to several other methods for diagnosing laryngopharyngeal reflux.


Condition
Laryngopharyngeal Reflux

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Diagnosis and Response to Treatment of Laryngopharyngeal Reflux Using an Oropharyngeal Aerosolized pH Probe

Resource links provided by NLM:


Further study details as provided by Emory University:

Enrollment: 45
Study Start Date: May 2006
Study Completion Date: May 2007
Primary Completion Date: May 2007 (Final data collection date for primary outcome measure)
Detailed Description:

It is estimated that up to 50% of patients with voice disorders and 4-10% of patients seen in otolaryngology practice experience laryngopharyngeal reflux (LPR). LPR has been implicated in the pathogenesis of numerous laryngeal disorders, including subglottic stenosis, laryngeal carcinoma, laryngeal contact ulcers, laryngospasm, and vocal cord nodules. In the pediatric population, it has been associated with asthma, sinusitis, and otitis media. Common symptoms include chronic and intermittent hoarseness, vocal fatigue, globus pharyngeus, cough, postnasal drip, chronic throat clearing, and dysphagia.

Like gastroesophageal reflux disease (GERD), the etiology of LPR is linked to esophageal sphincter dysfunction. In GERD, the lower esophageal sphincter (LES) is involved, whereas in LPR, the pathology results from upper esophageal sphincter (UES) dysfunction. However, diagnosis of LPR is more challenging than that of GERD. The classic reflux-like symptoms of heartburn and regurgitation are often absent in LPR.

The most widely used diagnostic modality for LPR is symptomatic response to treatment, including twice daily proton pump inhibitor (PPI) or H2 blocker therapy for several months. However, the use of a therapeutic modality to make a diagnosis clearly carries disadvantages, including potentially unnecessary exposure to a drug's side effect profile and lengthy time to diagnosis. Another diagnostic instrument is the reflux symptom index (RSI), a validated nine-item questionnaire assessing LPR symptoms. However, LPR symptoms are fairly nonspecific, also appearing in autoimmune and behavior disorders. Lastly, a 24-hour triple-pH probe may be the best objective test diagnosing LPR. However, this method is poorly tolerated by patients and difficulty with ease of administration limits its routine use. To date, we have remained in search of a minimally invasive and specific test for LPR.

In this study, we will investigate the use of a newly developed oropharyngeal pH probe for detecting aerosolized acid as an accurate and minimally invasive diagnostic instrument for LPR. This device has previously been shown to correlate to lower esophageal, upper esophageal, and lower pharyngeal pH as measured by a 24-hour triple channel bifurcated pH probe [ACG Poster session by Dr. G Wiener]. The number of oropharyngeal aerosolized acid reflux events and acid exposure times will be compared to RSI before and after twice daily proton pump inhibitor therapy. In addition, the correlation between acid reflux events and acid exposure times as measured by the Dx probe will be more rigorously compared to that measured by a triple pH probe.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Pos controls: Subjects visiting the Emory Clinic/Emory Voice center with LPR symptoms.

Neg controls: Random subjects in Atlanta without LPR symptoms. See other descriptions for more details.

Criteria

INCLUSION CRITERIA:

Group 1 (negative control):

  • RSI ≤ 13
  • No history of voice or swallowing disorders
  • No active voice or swallowing disorders
  • No history of heartburn, regular indigestion, and no prior or current diagnosis of GERD

Groups 2 and 3 (experimental group):

  • Clinical symptoms consistent with LPR as measured by an RSI > 13.
  • No other voice or swallowing pathology on clinical exam

EXCLUSION CRITERIA:

  • Regular treatment with an H2 blocker or proton pump inhibitor (PPI)
  • History of laryngeal/pharyngeal surgery
  • Any planned treatment of the larynx/pharynx other than treatment for LPR
  • Smoking
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00321503

Locations
United States, Georgia
Emory Voice Center
Atlanta, Georgia, United States, 30309
Sponsors and Collaborators
Emory University
AstraZeneca
Respiratory Technology Corporation
Investigators
Principal Investigator: Adam Klein, MD Dept of Otolaryngology
Study Chair: Michael M Johns, MD Dept of Otolaryngology / Director of Emory Voice Center
Principal Investigator: Leena Khaitan, MD, MPH Dept of Surgery
Study Director: Justin S Golub, BA Emory University
  More Information

Publications:
Responsible Party: Adam Klein, Principal Investigator, Emory University
ClinicalTrials.gov Identifier: NCT00321503     History of Changes
Other Study ID Numbers: 1345-2005, DX-1 for LPR
Study First Received: May 2, 2006
Last Updated: December 6, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Emory University:
acid reflux
LPR
gastroesophageal reflux
GERD
pH probe
proton pump inhibitor
PPI

Additional relevant MeSH terms:
Gastroesophageal Reflux
Regurgitation, Gastric
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 22, 2014