Investigation of the Association Between Nasal Polyposis and Extraesophageal Reflux Disease

This study has been completed.
Sponsor:
Information provided by:
Head and Neck Surgery Associates
ClinicalTrials.gov Identifier:
NCT00215787
First received: September 15, 2005
Last updated: September 21, 2010
Last verified: September 2010
  Purpose

Although nasal polyposis has been recognized as an inflammatory process for many years, the true etiology of nasal polyposis mainly unknown. Despite surgical removal, the recurrence rate after surgery has been reported as high as 87% within the first year after surgery. Anecdotally the Principal Investigator found an incidence of pH probe-proven laryngopharyngeal reflux approaching 80% in his patients with nasal polyposis. Although his number of cases was small, the incidence of recurrence of polyps in these patients was 17%.

The PI believes that such an association is too great to be explained by chance alone, and deserves further study. He anticipates two contributions to the literature from this study, the first documenting the incidence of extraesophageal (laryngopharyngeal) reflux in patients with polyposis, and the second showing the impact of reflux treatment on the recurrence rate of the polyps, initially after one year of therapy.


Condition Intervention
Nasal Polyps
Gastroesophageal Reflux
Drug: lansoprazole

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Investigation of the Association Between Nasal Polyposis and Extraesophageal Reflux Disease

Resource links provided by NLM:


Further study details as provided by Head and Neck Surgery Associates:

Primary Outcome Measures:
  • Presence of Reflux in Patients With Polyposis [ Time Frame: one year ] [ Designated as safety issue: No ]
    Presence of Laryngopharyngeal reflux was measured by 24 hour pH impedance probe monitor per equipment manufacturer software. Two or more episodes in twenty four hours was considered positive, in accordance with published standards.


Enrollment: 20
Study Start Date: September 2005
Study Completion Date: September 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: lansoprazole
    Lansoprazole 30 mg BID for 1 year
    Other Name: Prevacid is the brand name for this drug
Detailed Description:

Although nasal polyposis has been recognized as an inflammatory process for many years, the true etiology of nasal polyposis mainly unknown. Despite surgical removal, the recurrence rate after surgery has been reported as high as 87% within the first year after surgery. Anecdotally the Principal Investigator found an incidence of pH probe-proven laryngopharyngeal reflux approaching 80% in his patients with nasal polyposis. Although his number of cases was small, the incidence of recurrence of polyps in these patients was 17%.

The PI believes that such an association is too great to be explained by chance alone, and deserves further study. He anticipates two contributions to the literature from this study, the first documenting the incidence of extraesophageal (laryngopharyngeal) reflux in patients with polyposis, and the second showing the impact of reflux treatment on the recurrence rate of the polyps, initially after one year of therapy.

Eligible patients found to have nasal polyps will be offered the chance to participate in this study. They will undergo non-invasive pH probe monitoring for 24 hours. If extraesophageal (laryngopharyngeal) reflux is discovered, they will be provided (at no cost) proton pump inhibitor medication (PPI), prescribed in accordance with published standards in the otolaryngology literature. Their polyposis will be treated as any other patient presenting with polyposis; participation in the study will not affect the course of polyp treatment. The incidence of recurrence will be monitored and recorded over the first year after treatment.

Included: Subjects will be adults with nasal polyposis, recruited from the PI's private practice, will not be currently taking a PP!, will be able and willing to undergo a noninvasive 24 hour pH probe study, and willing to take a PPI. Excluded: patients who are pregnant, have a history of surgical treatment for reflux disease, history of allergic or adverse reaction to Prevacid or adverse reaction to Prevacid during the study period, and those not meeting inclusion criteria.

In addition to routine office otolaryngology examination, subjects will undergo noninvasive 24 hour esophageal pH probe monitoring. The probe is swallowed and placed in the same manner as a feeding tube. The procedure is done in the office. No sedation is required, but the mucosa may be sprayed with topical 4% lidocaine for comfort. This procedure is the standard for diagnosis of extraesophageal (laryngopharyngeal) reflux, and will be performed in accordance with manufacturer guidelines

Risks include temporary dysphagia while the probe is in place, and nasal irritation. Mild, self-limited epistaxis has been rarely reported

The procedure will be done within manufcturer guidelines under direct vision. Topical Afrin may be used to control any mild epistaxis. Topical 4% lidocaine will be applied to minimize dysphagia. These steps have proven very affective in minimizing these risks.

If the study hypothesis is correct, the patient may have an diminished risk of recurrence of their nasal polyposis. If the patient is found to have previously undiagnosed reflux disease, this will allow it to be treated appropriately. Undiagnosed/untreated reflux has been associated with multiple medical problems including laryngeal and esophageal cancer. The patient will be given their PPI medication free of charge for the duration of the study. The noninvasive pH probe study will be done free of charge. No direct monetary payment will be given to participants.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Subjects will:

  • Be adults with nasal polyposis
  • recruited from the PI's private practice
  • Not be currently taking a PPI
  • Be able and willing to undergo a noninvasive 24 hour pH probe study; and
  • Take a PPI.

Exclusion Criteria:

Patients who:

  • Are pregnant
  • Have a history of surgical treatment for reflux disease
  • History of allergic or adverse reaction to Prevacid or adverse reaction to Prevacid during the study period; and
  • Do not meet inclusion criteria.
  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: NCT00215787

Locations
United States, Indiana
Head and Neck Surgery Associates
Indianapolis, Indiana, United States, 46250
Sponsors and Collaborators
Head and Neck Surgery Associates
Investigators
Principal Investigator: Scott E Phillips, MD Head and Neck Surgery Associates
  More Information

Publications:
Responsible Party: Scott Phillips MD, Head and Neck Surgery Associates
ClinicalTrials.gov Identifier: NCT00215787     History of Changes
Other Study ID Numbers: 2005-0165
Study First Received: September 15, 2005
Results First Received: August 10, 2010
Last Updated: September 21, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Head and Neck Surgery Associates:
Nasal polyps
Gastroesophageal Reflux

Additional relevant MeSH terms:
Gastroesophageal Reflux
Nasal Polyps
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Nose Diseases
Respiratory Tract Diseases
Otorhinolaryngologic Diseases
Polyps
Pathological Conditions, Anatomical
Lansoprazole
Dexlansoprazole
Anti-Ulcer Agents
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on October 16, 2014