Randomized Placebo-Controlled Trial of BID Lansoprazole in Isolated Chronic Post Nasal Drip
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Post Nasal Drainage Symptom Response
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Sugar Pill
干预措施: manometry (Procedure)
Lansoprazole
干预措施: Lansoprazole Tablet (Drug)
Lansoprazole
干预措施: PH and impedence testing (Procedure)
Lansoprazole
干预措施: manometry (Procedure)
Lansoprazole
干预措施: lansoprazole (Drug)
Sugar Pill
干预措施: PH and impedence testing (Procedure)
Sugar Pill
干预措施: placebo (Drug)
结局指标
主要结局
Post Nasal Drainage Symptom Response
时间窗: 8 and 16 weeks
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.
次要结局
- Rhinosinusitis Outcome Measure(RSOM-31)(Baseline, 8 weeks, and 16 weeks)
- Sino Nasal Outcome Test (SNOT-20)(Baseline, 8 weeks and 16 weeks)
- Quality of Life Questionnaire (QOLRAD)(Baseline, 8 weeks and 16 weeks)
研究者
Michael Vaezi
Medical Director
Vanderbilt University
