Clinical trial NCT00335283: Efficacy of Lansoprazole in Chronic Post Nasal Drip
Official title: Randomized Placebo-Controlled Trial of BID Lansoprazole in Isolated Chronic Post Nasal Drip
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Larynx Disease
Lead sponsor: Vanderbilt University
Sponsor class: OTHER
Collaborators: name: TAP Pharmaceutical Products Inc.
First posted: 2006-06-09
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Post Nasal Drainage Symptom Response
timeFrame: 8 and 16 weeks
Secondary outcomes:
measure: Rhinosinusitis Outcome Measure(RSOM-31)
timeFrame: Baseline, 8 weeks, and 16 weeks
measure: Sino Nasal Outcome Test (SNOT-20)
timeFrame: Baseline, 8 weeks and 16 weeks
measure: Quality of Life Questionnaire (QOLRAD)
timeFrame: Baseline, 8 weeks and 16 weeks
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center, Vanderbilt Digestive Disease Clinic, TVC, Room 1660
state: Tennessee
Study officials:
affiliation: Vanderbilt University
name: Michael F Vaezi, MD PhD MS
role: PRINCIPAL_INVESTIGATOR
References: