Study of an Oropharyngeal Aerosolized pH Probe for Diagnosing Laryngopharyngeal Reflux (LPR)
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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 |
| Estimated Enrollment: | 45 |
| Study Start Date: | May 2006 |
| Estimated Study Completion Date: | May 2010 |
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 |
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.
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| Contact: Adam Klein, MD | 404-686-1850 | Adam.Klein@emoryhealthcare.org |
| Contact: Justin S Golub, BA | 404-686-1850 | jsgolub@emory.edu |
| 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 | |
| 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:
| ClinicalTrials.gov Identifier: | NCT00321503 History of Changes |
| Other Study ID Numbers: | 1345-05, DX-1 for LPR |
| Study First Received: | May 2, 2006 |
| Last Updated: | November 20, 2007 |
| 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 May 21, 2013