Efficacy of Lansoprazole in Chronic Post Nasal Drip (PND)

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.

Study Overview

• Status: Completed
• Conditions: Larynx Disease
• Intervention / Treatment: Drug: Lansoprazole Tablet; Procedure: PH and impedence testing; Procedure: manometry; Drug: lansoprazole; Drug: placebo

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: Interventional
• Enrollment (Actual): 75
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Tennessee
    • Nashville, Tennessee, United States, 37232-5280
      • Vanderbilt University Medical Center, Vanderbilt Digestive Disease Clinic, TVC, Room 1660

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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
Active Comparator: Lansoprazole	Drug: Lansoprazole Tablet; 40 mg bid x 16 weeks; Other Names: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post Nasal Drainage Symptom Response	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.	8 and 16 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rhinosinusitis Outcome Measure(RSOM-31)	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.	Baseline, 8 weeks, and 16 weeks
Sino Nasal Outcome Test (SNOT-20)	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.	Baseline, 8 weeks and 16 weeks
Quality of Life Questionnaire (QOLRAD)	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.	Baseline, 8 weeks and 16 weeks

Collaborators and Investigators

• Sponsor: Vanderbilt University
• Collaborators: TAP Pharmaceutical Products Inc.

Study record dates

Study Major Dates

• Study Start: August 1, 2006
• Primary Completion (Actual): December 1, 2008
• Study Completion (Actual): December 1, 2008

Study Registration Dates

• First Submitted: June 7, 2006
• First Submitted That Met QC Criteria: June 7, 2006
• First Posted (Estimate): June 9, 2006

Study Record Updates

• Last Update Posted (Estimate): August 21, 2012
• Last Update Submitted That Met QC Criteria: July 17, 2012
• Last Verified: June 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Laryngeal Diseases; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Gastrointestinal Agents; Anti-Ulcer Agents; Proton Pump Inhibitors; Dexlansoprazole; Lansoprazole
• Other Study ID Numbers: 051169