Gastroesophageal Reflux Clinical Trial
Official title:
Investigation of the Association Between Nasal Polyposis and Extraesophageal Reflux Disease
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.
Status | Completed |
Enrollment | 20 |
Est. completion date | September 2008 |
Est. primary completion date | September 2008 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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. |
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Head and Neck Surgery Associates | Indianapolis | Indiana |
Lead Sponsor | Collaborator |
---|---|
Head and Neck Surgery Associates |
United States,
Postma GN, Johnson LF, Koufman JA. Treatment of laryngopharyngeal reflux. Ear Nose Throat J. 2002 Sep;81(9 Suppl 2):24-6. Review. — View Citation
Vento SI, Ertama LO, Hytönen ML, Wolff CH, Malmberg CH. Nasal polyposis: clinical course during 20 years. Ann Allergy Asthma Immunol. 2000 Sep;85(3):209-14. — View Citation
Virolainen E, Puhakka H. The effect of intranasal beclomethasone dipropionate on the recurrence of nasal polyps after ethmoidectomy. Rhinology. 1980 Mar;18(1):9-18. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Presence of Reflux in Patients With Polyposis | 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. | one year | No |
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