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Efficacy of Lansoprazole in Chronic Post Nasal Drip

NCT ID: NCT00335283

Last Updated: 2012-08-21

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-08-31

Study Completion Date

2008-12-31

Brief Summary

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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

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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.

Conditions

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Larynx Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Lansoprazole

Group Type ACTIVE_COMPARATOR

Lansoprazole Tablet

Intervention Type DRUG

40 mg bid x 16 weeks

PH and impedence testing

Intervention Type PROCEDURE

24 hour ph monitoring

manometry

Intervention Type PROCEDURE

done prior to pH probe to measure length of esophagus

lansoprazole

Intervention Type DRUG

40mg bid

Sugar Pill

Group Type PLACEBO_COMPARATOR

PH and impedence testing

Intervention Type PROCEDURE

24 hour ph monitoring

manometry

Intervention Type PROCEDURE

done prior to pH probe to measure length of esophagus

placebo

Intervention Type DRUG

one tablet bid

Interventions

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Lansoprazole Tablet

40 mg bid x 16 weeks

Intervention Type DRUG

PH and impedence testing

24 hour ph monitoring

Intervention Type PROCEDURE

manometry

done prior to pH probe to measure length of esophagus

Intervention Type PROCEDURE

lansoprazole

40mg bid

Intervention Type DRUG

placebo

one tablet bid

Intervention Type DRUG

Other Intervention Names

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prevacid

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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TAP Pharmaceutical Products Inc.

INDUSTRY

Sponsor Role collaborator

Vanderbilt University

OTHER

Sponsor Role lead

Responsible Party

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Michael Vaezi

Medical Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Michael F Vaezi, MD PhD MS

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt University

Locations

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

Nashville, Tennessee, United States

Site Status

Countries

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United States

Other Identifiers

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051169

Identifier Type: -

Identifier Source: org_study_id