Efficacy of Lansoprazole in Chronic Post Nasal Drip

Official Title: “Randomized Placebo-Controlled Trial of BID Lansoprazole in Isolated 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.

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.

Intervention(s) in this Clinical Trial

• Drug: Lansoprazole Tablet
  • 40 mg bid x 16 weeks
• 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

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: 1
• Placebo Comparator: 2
  • placebo

Primary Measures

• symptom improvement at 4 months
  • Time Frame: 4 months
    Safety Issue?: Yes

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Vanderbilt University Other

Overall Clinical Trial Officials and Contacts

Michael F Vaezi, MD PhD MS Principal Investigator Vanderbilt University  

Information obtained from ClinicalTrials.gov on February 09, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00335283

Study ID Number: 051169

ClinicalTrials.gov Identifier: NCT00335283

Health Authority: United States: Institutional Review Board