Efficacy of Lansoprazole in Chronic Post Nasal Drip - Full Text View

Sponsor:	Vanderbilt University
Information provided by:	Vanderbilt University
ClinicalTrials.gov Identifier:	NCT00335283

Purpose

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.

Condition	Intervention	Phase
Larynx Disease	Drug: Lansoprazole Tablet Procedure: PH and impedence testing Procedure: manometry Drug: lansoprazole Drug: placebo	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment
Official Title:	Randomized Placebo-Controlled Trial of BID Lansoprazole in Isolated Chronic Post Nasal Drip

Resource links provided by NLM:

Drug Information available for: Lansoprazole

U.S. FDA Resources

Further study details as provided by Vanderbilt University:

Primary Outcome Measures:

symptom improvement at 4 months [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	100
Study Start Date:	August 2006
Estimated Study Completion Date:	November 2008
Estimated Primary Completion Date:	November 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator	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
2: Placebo Comparator placebo	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

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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
Isolated chronic cough without the symptom of post nasal drip

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00335283

Locations

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

Sponsors and Collaborators

Vanderbilt University

Investigators

Principal Investigator:

Michael F Vaezi, MD PhD MS

Vanderbilt University

More Information

No publications provided

Responsible Party:	Vanderbilt University Medical Center ( Michael F. Vaezi, MD, PhD, MS epi )
Study ID Numbers:	051169
Study First Received:	June 7, 2006
Last Updated:	August 5, 2008
ClinicalTrials.gov Identifier:	NCT00335283 History of Changes
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Anti-Infective Agents
Otorhinolaryngologic Diseases
Molecular Mechanisms of Pharmacological Action
Respiratory Tract Diseases
Therapeutic Uses
Anti-Ulcer Agents

Gastrointestinal Agents
Enzyme Inhibitors
Lansoprazole
Laryngeal Diseases
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 08, 2010