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Completed

NCT Number: NCT00335283

Efficacy of Lansoprazole in Chronic Post Nasal Drip

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

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

Nashville, Tennessee, 37232-5280, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lansoprazole Tablet

Drug

40 mg bid x 16 weeks

Other names: prevacid

PH and impedence testing

Procedure

24 hour ph monitoring

Manometry

Procedure

done prior to pH probe to measure length of esophagus

Lansoprazole

Drug

40mg bid

Placebo

Drug

one tablet bid

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Vanderbilt University

Other

Collaborators

  • TAP Pharmaceutical Products Inc.

Registry information

Official study title

Randomized Placebo-Controlled Trial of BID Lansoprazole in Isolated Chronic Post Nasal Drip

Acronym: PND

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Jun 9, 2006
Registry last updated
Aug 21, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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