- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00321503
Study of an Oropharyngeal Aerosolized pH Probe for Diagnosing Laryngopharyngeal Reflux (LPR)
Diagnosis and Response to Treatment of Laryngopharyngeal Reflux Using an Oropharyngeal Aerosolized pH Probe
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Georgia
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Atlanta, Georgia, United States, 30309
- Emory Voice Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
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.
Description
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
Study Plan
How is the study designed?
Design Details
- Time Perspectives: Prospective
Collaborators and Investigators
Sponsor
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
Publications and helpful links
General Publications
- Belafsky PC, Postma GN, Koufman JA. Validity and reliability of the reflux symptom index (RSI). J Voice. 2002 Jun;16(2):274-7. doi: 10.1016/s0892-1997(02)00097-8.
- Merati AL, Lim HJ, Ulualp SO, Toohill RJ. Meta-analysis of upper probe measurements in normal subjects and patients with laryngopharyngeal reflux. Ann Otol Rhinol Laryngol. 2005 Mar;114(3):177-82. doi: 10.1177/000348940511400302.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1345-2005
- DX-1 for LPR (Other Identifier: other)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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