NCT00335283

Efficacy of Lansoprazole in Chronic Post Nasal Drip

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 75 (actual)
• Sponsor: Vanderbilt University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Larynx Disease

Interventions

Type	Name	Description
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
DRUG	placebo	one tablet bid

Timeline

• Start date: 2006-08-01
• Primary completion: 2008-12-01
• Completion: 2008-12-01
• First posted: 2006-06-09
• Last updated: 2012-08-21
• Results posted: 2012-08-21

Locations

1 site across 1 country: United States