Efficacy of Lansoprazole in Chronic Post Nasal Drip

Phase 3

Completed

Conditions: Larynx Disease

Interventions: Drug: Lansoprazole Tablet
Procedure: PH and impedence testing
Procedure: manometry
Drug: placebo
Drug: lansoprazole

Registration Number: NCT00335283

Lead Sponsor: 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.

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 75

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 & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lansoprazole	Lansoprazole Tablet	-
Lansoprazole	PH and impedence testing	-
Lansoprazole	manometry	-
Lansoprazole	lansoprazole	-
Sugar Pill	PH and impedence testing	-
Sugar Pill	manometry	-
Sugar Pill	placebo	-

Primary Outcome Measures

Name	Time	Method
Post Nasal Drainage Symptom Response	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

Name	Time	Method
Rhinosinusitis Outcome Measure(RSOM-31)	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.
Sino Nasal Outcome Test (SNOT-20)	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.
Quality of Life Questionnaire (QOLRAD)	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.