NCT00215787

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2005

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2005

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

September 15, 2005

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 22, 2005

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2008

Completed
2.1 years until next milestone

Results Posted

Study results publicly available

September 22, 2010

Completed
Last Updated

September 22, 2010

Status Verified

September 1, 2010

Enrollment Period

3 years

First QC Date

September 15, 2005

Results QC Date

August 10, 2010

Last Update Submit

September 21, 2010

Conditions

Nasal PolypsGastroesophageal Reflux

Keywords

Nasal polypsGastroesophageal Reflux

Outcome Measures

Primary Outcomes (1)

  • 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

Interventions

lansoprazoleDRUG

Lansoprazole 30 mg BID for 1 year

Also known as: Prevacid is the brand name for this drug

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Head and Neck Surgery Associates

Indianapolis, Indiana, 46250, United States

Location

Related Publications (3)

  • Vento SI, Ertama LO, Hytonen ML, Wolff CH, Malmberg CH. Nasal polyposis: clinical course during 20 years. Ann Allergy Asthma Immunol. 2000 Sep;85(3):209-14. doi: 10.1016/S1081-1206(10)62468-4.

    PMID: 11030275BACKGROUND

  • 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.

    PMID: 6988929BACKGROUND

  • Postma GN, Johnson LF, Koufman JA. Treatment of laryngopharyngeal reflux. Ear Nose Throat J. 2002 Sep;81(9 Suppl 2):24-6.

    PMID: 12353429BACKGROUND

MeSH Terms

Conditions

Nasal PolypsGastroesophageal Reflux

Interventions

Lansoprazole

Condition Hierarchy (Ancestors)

Nose DiseasesRespiratory Tract DiseasesOtorhinolaryngologic DiseasesPolypsPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsEsophageal Motility DisordersDeglutition DisordersEsophageal DiseasesGastrointestinal DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

2-PyridinylmethylsulfinylbenzimidazolesSulfoxidesSulfur CompoundsOrganic ChemicalsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsBenzimidazolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Results Point of Contact

Title
Scott Phillips
Organization
Head and Neck Surgery Associates
sphillips@hnsaonline.com
317-926-1056

Study Officials

  • Scott E Phillips, MD

    Head and Neck Surgery Associates

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 15, 2005

First Posted

September 22, 2005

Study Start

September 1, 2005

Primary Completion

September 1, 2008

Study Completion

September 1, 2008

Last Updated

September 22, 2010

Results First Posted

September 22, 2010

Record last verified: 2010-09

Locations

US(1)