|
|
|
|
|
|
Sponsored by: |
Vanderbilt University |
Information provided by: | Vanderbilt University |
ClinicalTrials.gov Identifier: | NCT00335283 |
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 |
ChemIDplus related topics: | Lansoprazole Salicylsalicylic acid Sodium salicylate |
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 |
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
|
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Positive RAST or Positive skin testing AND insufficient response to all of the following: (Group B)
Exclusion Criteria:
United States, Tennessee | |||||
Vanderbilt University Medical Center, Vanderbilt Digestive Disease Clinic, TVC, Room 1660 | |||||
Nashville, Tennessee, United States, 37232-5280 |
Vanderbilt University |
Principal Investigator: | Michael F Vaezi, MD PhD MS | Vanderbilt University |
Responsible Party: | Vanderbilt University Medical Center ( Michael F. Vaezi, MD, PhD, MS epi ) |
Study ID Numbers: | 051169 |
First Received: | June 7, 2006 |
Last Updated: | August 5, 2008 |
ClinicalTrials.gov Identifier: | NCT00335283 |
Health Authority: | United States: Institutional Review Board |
|
|
|
|