NCT00335283

Brief Summary

The purpose of this study is to determine whether aggressive acid suppression with Lansoprazole is effective in the treatment of post nasal drip, and also assess the predictors of response based on clinical and physiologic parameters.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
75

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Aug 2006

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

First Submitted

Initial submission to the registry

June 7, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 9, 2006

Completed
2 months until next milestone

Study Start

First participant enrolled

August 1, 2006

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
3.7 years until next milestone

Results Posted

Study results publicly available

August 21, 2012

Completed
Last Updated

August 21, 2012

Status Verified

June 1, 2012

Enrollment Period

2.3 years

First QC Date

June 7, 2006

Results QC Date

March 28, 2011

Last Update Submit

July 17, 2012

Conditions

Larynx Disease

Outcome Measures

Primary Outcomes (1)

  • Post Nasal Drainage Symptom Response

    The primary outcome measure was postnasal drainage symptom response measured by using a visual analogue scale. At 8 and 16 weeks, a horizontal symptoms scale from 0% (no change) to 100% (symptoms completely resolved) was presented to participants to assess improvement in postnasal drainage symptoms.

    8 and 16 weeks

Secondary Outcomes (3)

  • Rhinosinusitis Outcome Measure(RSOM-31)

    Baseline, 8 weeks, and 16 weeks

  • Sino Nasal Outcome Test (SNOT-20)

    Baseline, 8 weeks and 16 weeks

  • Quality of Life Questionnaire (QOLRAD)

    Baseline, 8 weeks and 16 weeks

Study Arms (2)

Lansoprazole

ACTIVE COMPARATOR
Drug: Lansoprazole TabletProcedure: PH and impedence testingProcedure: manometryDrug: lansoprazole

Sugar Pill

PLACEBO COMPARATOR
Procedure: PH and impedence testingProcedure: manometryDrug: placebo

Interventions

Lansoprazole TabletDRUG

40 mg bid x 16 weeks

Also known as: prevacid
Lansoprazole
PH and impedence testingPROCEDURE

24 hour ph monitoring

LansoprazoleSugar Pill
manometryPROCEDURE

done prior to pH probe to measure length of esophagus

LansoprazoleSugar Pill
lansoprazoleDRUG

40mg bid

Lansoprazole
placeboDRUG

one tablet bid

Sugar Pill

Eligibility Criteria

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

You may qualify if:

  • Negative RAST inhalant allergy panel OR negative skin testing (Group A)
  • Positive RAST or Positive skin testing AND insufficient response to all of the following: (Group B)
  • Allergen avoidance
  • Topical nasal steroids
  • Allergy shots if indicated
  • Antihistamines
  • Negative CT sinuses (coronal)
  • \< 4mm of mucosal thickening and \< 3 sinus sites
  • Absence of air-fluid levels
  • Negative anterior rhinoscopy
  • Absence of pus, crusts on mucosal surfaces

You may not qualify if:

  • Age \< 18
  • Pregnancy, confirmed by urine pregnancy test at day of randomization
  • Ciliary dyskinesia
  • Immune deficiency
  • Cystic fibrosis
  • Diagnosis of acute sinusitis or chronic RS (AAO-HNS)
  • Active use of topical decongestant
  • Use of PPI within the last 30 days
  • Previous fundoplication
  • Uncontrolled thyroid disease
  • Isolated chronic cough without the symptom of post nasal drip

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vanderbilt University Medical Center, Vanderbilt Digestive Disease Clinic, TVC, Room 1660

Nashville, Tennessee, 37232-5280, United States

Location

MeSH Terms

Conditions

Laryngeal Diseases

Interventions

LansoprazoleHydrogen-Ion ConcentrationManometry

Condition Hierarchy (Ancestors)

Respiratory Tract DiseasesOtorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

2-PyridinylmethylsulfinylbenzimidazolesSulfoxidesSulfur CompoundsOrganic ChemicalsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsBenzimidazolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingChemical PhenomenaInvestigative Techniques

Limitations and Caveats

Sample size of 75 participants is small. Lack of an objective measure of postnasal drainage limited the study outcome to be symptom based.

Results Point of Contact

Title
Manager, Clinical Trials
Organization
Vanderbilt University Medical Center
tina.higginbotham@vanderbilt.edu
615-322-4643

Study Officials

  • Michael F Vaezi, MD PhD MS

    Vanderbilt University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Director

Study Record Dates

First Submitted

June 7, 2006

First Posted

June 9, 2006

Study Start

August 1, 2006

Primary Completion

December 1, 2008

Study Completion

December 1, 2008

Last Updated

August 21, 2012

Results First Posted

August 21, 2012

Record last verified: 2012-06

Locations

US(1)