Efficacy of Lansoprazole in Chronic Post Nasal Drip

Larynx Disease Clinical Trial

— PND  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00335283
• Other study ID #: 051169
• Status: Completed
• Phase: Phase 3
• First received: June 7, 2006
• Last updated: July 17, 2012
• Start date: August 2006
• Est. completion date: December 2008

Study information

• Verified date: June 2012
• Source: Vanderbilt University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Laryngeal Diseases
• Larynx Disease

Intervention

Drug:
• Lansoprazole Tablet
40 mg bid x 16 weeks

Procedure:
• PH and impedence testing
24 hour ph monitoring
• manometry
done prior to pH probe to measure length of esophagus

Drug:
• lansoprazole
40mg bid
• placebo
one tablet bid

Locations

Country	Name	City	State
United States	Vanderbilt University Medical Center, Vanderbilt Digestive Disease Clinic, TVC, Room 1660	Nashville	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
Vanderbilt University	TAP Pharmaceutical Products Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No