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Efficacy of Lansoprazole in Chronic Post Nasal Drip (PND)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00335283
Recruitment Status : Completed
First Posted : June 9, 2006
Results First Posted : August 21, 2012
Last Update Posted : August 21, 2012
Sponsor:
Collaborator:
TAP Pharmaceutical Products Inc.
Information provided by (Responsible Party):
Michael Vaezi, Vanderbilt University

Tracking Information
First Submitted Date  ICMJE June 7, 2006
First Posted Date  ICMJE June 9, 2006
Results First Submitted Date  ICMJE March 28, 2011
Results First Posted Date  ICMJE August 21, 2012
Last Update Posted Date August 21, 2012
Study Start Date  ICMJE August 2006
Actual Primary Completion Date December 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 17, 2012)
Post Nasal Drainage Symptom Response [ Time Frame: 8 and 16 weeks ]
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.
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 17, 2012)
  • Rhinosinusitis Outcome Measure(RSOM-31) [ Time Frame: Baseline, 8 weeks, and 16 weeks ]
    RSOM-31 includes 31 questions combined into a total score ranging from 0 to 155 with higher scores representing greater disease burden. Values are based on patient report.
  • Sino Nasal Outcome Test (SNOT-20) [ Time Frame: Baseline, 8 weeks and 16 weeks ]
    SNOT-20 includes 20 questions combined into a total score ranging from 0 to 100 with higher numbers representing greater rhinosinusitis health burden and represents patient-reported symptom severity.
  • Quality of Life Questionnaire (QOLRAD) [ Time Frame: Baseline, 8 weeks and 16 weeks ]
    The patient-reported QOLRAD consists of 25 questions combined into a total score ranging from 25 to 175 with higher numbers representing better quality of life.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy of Lansoprazole in Chronic Post Nasal Drip
Official Title  ICMJE Randomized Placebo-Controlled Trial of BID Lansoprazole in Isolated Chronic Post Nasal Drip
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.
Detailed Description Postnasal drip (PND) is a common complaint that brings patients to the attention of their primary care physicians. It is also one of the most common reasons for patients to seek care from otolaryngologists. Traditionally, PND has been considered and treated as a symptom of sinonasal pathology. It has also been shown, along with Gastroesophageal reflux disease (GERD) and asthma, to be a major contributor to the development of chronic cough. PND refractory to treatment aimed at sinonasal disease is sometimes treated with anti-GERD therapy. This treatment modality is based on clinical experience. To date, there are no studies in the literature to support a causal relationship between PND and extraesophageal reflux (EER). In a case control study of patients with and without esophagitis El-Serag et al reported a significant association (odds ratio 1.6, 95%CI 1.4-1.8) between sinusitis and GERD. A later study by Ulualp et al in 11 CT confirmed cases of chronic sinusitis resistant to therapy with conventional sinus therapies they found a significantly higher prevalence of hypopharyngeal acid exposure in the sinusitis group than controls. Recently, in an open label prospective pilot trial, DiBaise et al treated 11 patients with sinusitis and 19 GERD patients with omeprazole 20mg bid for 3-months. 9/11 sinusitis patients were found to have GERD by pH monitoring and there was moderate (25-89%) improvement in the sinus symptoms in the omeprazole treated group. However, there are currently no placebo-controlled trials assessing efficacy of PPI's in patients with PND.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Larynx Disease
Intervention  ICMJE
  • Drug: Lansoprazole Tablet
    40 mg bid x 16 weeks
    Other Name: prevacid
  • Procedure: PH and impedence testing
    24 hour ph monitoring
  • Procedure: manometry
    done prior to pH probe to measure length of esophagus
  • Drug: lansoprazole
    40mg bid
  • Drug: placebo
    one tablet bid
Study Arms  ICMJE
  • Active Comparator: Lansoprazole
    Interventions:
    • Drug: Lansoprazole Tablet
    • Procedure: PH and impedence testing
    • Procedure: manometry
    • Drug: lansoprazole
  • Placebo Comparator: Sugar Pill
    Interventions:
    • Procedure: PH and impedence testing
    • Procedure: manometry
    • Drug: placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 16, 2010)
75
Original Enrollment  ICMJE
 (submitted: June 7, 2006)
100
Actual Study Completion Date  ICMJE December 2008
Actual Primary Completion Date December 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00335283
Other Study ID Numbers  ICMJE 051169
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Michael Vaezi, Vanderbilt University
Study Sponsor  ICMJE Vanderbilt University
Collaborators  ICMJE TAP Pharmaceutical Products Inc.
Investigators  ICMJE
Principal Investigator: Michael F Vaezi, MD PhD MS Vanderbilt University
PRS Account Vanderbilt University
Verification Date June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP