ClinicalTrials.gov
 Home    Search    Study Topics    Glossary  
 

  Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Study of an Oropharyngeal Aerosolized pH Probe for Diagnosing Laryngopharyngeal Reflux (LPR)

This study is currently recruiting participants.
Verified by Emory University, November 2007

Sponsors and Collaborators: Emory University
AstraZeneca
ResTech Corp
Information provided by: Emory University
ClinicalTrials.gov Identifier: NCT00321503
  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

U.S. FDA Resources

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

Further study details as provided by Emory University:

Biospecimen Retention:   None Retained

Biospecimen Description:

Estimated Enrollment:   45
Study Start Date:   May 2006
Estimated Study Completion Date:   May 2010

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

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

Contacts
Contact: Adam Klein, MD     404-686-1850     Adam.Klein@emoryhealthcare.org    
Contact: Justin S Golub, BA     404-686-1850     jsgolub@emory.edu    

Locations
United States, Georgia
Emory Voice Center     Recruiting
      Atlanta, Georgia, United States, 30309
      Contact: Adam Klein, MD     404-686-1850     Adam.Klein@emoryhealthcare.org    
      Contact: Michael M Johns, MD     404-686-1850     Michael.M.Johns@emoryhealthcare.org    
      Sub-Investigator: Justin S Golub, BA            
      Principal Investigator: Adam Klein, MD            
      Sub-Investigator: Michael M Johns, MD            
      Principal Investigator: Leena Khaitan, MD, MPH            

Sponsors and Collaborators
Emory University
AstraZeneca
ResTech Corp

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:

Study ID Numbers:   1345-05, DX-1 for LPR
First Received:   May 2, 2006
Last Updated:   November 20, 2007
ClinicalTrials.gov Identifier:   NCT00321503
Health Authority:   United States: Institutional Review Board

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

Study placed in the following topic categories:
Gastroesophageal Reflux

ClinicalTrials.gov processed this record on November 06, 2008




Links to all studies - primarily for crawlers