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Efficacy of Lansoprazole in Chronic Post Nasal Drip (PND)

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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

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.

Condition or disease Intervention/treatment Phase
Larynx Disease Drug: Lansoprazole Tablet Procedure: PH and impedence testing Procedure: manometry Drug: lansoprazole Drug: placebo Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Placebo-Controlled Trial of BID Lansoprazole in Isolated Chronic Post Nasal Drip
Study Start Date : August 2006
Actual Primary Completion Date : December 2008
Actual Study Completion Date : December 2008

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Lansoprazole 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

Placebo Comparator: Sugar Pill Procedure: PH and impedence testing
24 hour ph monitoring

Procedure: manometry
done prior to pH probe to measure length of esophagus

Drug: placebo
one tablet bid




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00335283


Locations
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United States, Tennessee
Vanderbilt University Medical Center, Vanderbilt Digestive Disease Clinic, TVC, Room 1660
Nashville, Tennessee, United States, 37232-5280
Sponsors and Collaborators
Vanderbilt University
TAP Pharmaceutical Products Inc.
Investigators
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Principal Investigator: Michael F Vaezi, MD PhD MS Vanderbilt University

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Responsible Party: Michael Vaezi, Medical Director, Vanderbilt University
ClinicalTrials.gov Identifier: NCT00335283     History of Changes
Other Study ID Numbers: 051169
First Posted: June 9, 2006    Key Record Dates
Results First Posted: August 21, 2012
Last Update Posted: August 21, 2012
Last Verified: June 2012

Additional relevant MeSH terms:
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Laryngeal Diseases
Respiratory Tract Diseases
Otorhinolaryngologic Diseases
Lansoprazole
Dexlansoprazole
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action