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Laryngopharyngeal RefluxNCT00321503

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

An observational study of Laryngopharyngeal Reflux, run by Emory University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Laryngopharyngeal Reflux
How many people
45 participants
Where
1 siteUnited States
Study dates
May 2006to May 2007
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

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.

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Emory Voice Center

    Atlanta, Georgia, 30309

Other trials in United States

About this study

Official title: Diagnosis and Response to Treatment of Laryngopharyngeal Reflux Using an Oropharyngeal Aerosolized pH Probe

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.

Read the 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.

Keywords
acid reflux, LPR, gastroesophageal reflux, GERD, pH probe, proton pump inhibitor, PPI
Medical subject headings
Laryngopharyngeal Reflux, Gastroesophageal Reflux

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 May 2006 (estimated)
  2. Study startMay 2006
  3. Primary completionMay 2007
  4. Study completionMay 2007

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Time perspective
Prospective
Enrolment
45 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00321503
Sponsor's protocol ID
1345-2005
Other IDs
DX-1 for LPR
Status last verified
Dec 2013
First submitted
2 May 2006
Last updated
9 Dec 2013
Results posted
No

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.

    PubMed 12150380
  • 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.

    PubMed 15825565

Questions about this trial

What is this clinical trial studying?

An observational study of Laryngopharyngeal Reflux, run by Emory University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00321503, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2013.

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