Efficacy of Lansoprazole in Chronic Post Nasal Drip

Condition(s) targeted: Larynx Disease

Intervention: Lansoprazole Tablet (Drug); PH and impedence testing (Procedure); manometry (Procedure); lansoprazole (Drug); placebo (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Vanderbilt University

Official(s) and/or principal investigator(s):
Michael F Vaezi, MD PhD MS, Principal Investigator, Affiliation: Vanderbilt University

Overall contact:
barbara mccafferty, RN, Phone: 615-322-1897, Email: barbara.mccafferty@vanderbilt.edu

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.

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

Study design: Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment

Primary outcome: symptom improvement at 4 months

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.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

- Primary symptoms of cough and hoarseness

barbara mccafferty, RN, Phone: 615-322-1897, Email: barbara.mccafferty@vanderbilt.edu

Vanderbilt University Medical Center, Vanderbilt Digestive Disease Clinic, TVC, Room 1660, Nashville, Tennessee 37232-5280, United States; Recruiting
barbara mccafferty, RN, Phone: 615-322-1897, Email: barbara.mccafferty@vanderbilt.edu
Michael F Vaezi, MD, Principal Investigator

Starting date: August 2006
Ending date: October 2008
Last updated: April 8, 2008