Effect of Aggressive Acid Suppression With Esomeprazole on Vocal Cord Granulomas: Randomized Placebo-Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- • Primary outcome: Vocal cord granuloma improvement +/- resolution Outcome categories-subjectively assessed at laryngoscopy (current practice)
研究概览
简要总结
The purpose of this research study is to measure the effects of the drug, esomeprazole 40 mg (Nexium) or placebo (inactive drug) on vocal cord granulomas.
详细描述
Vocal cord granulomas (VCG) are common structural lesions of vocal cords attributed to vocal abuse / misuse and recently to gastroesophageal reflux. Vocal process granulomas are reactive/reparative process, in which an intact or ulcerated squamous epithelium is underlaid by granulation tissue or fibrosis (4, 5). Ulualp et al (6) have reported a higher prevalence of pharyngeal acid reflux (PAR) events in patients with vocal cord lesions. In a case control study they showed that the prevalence of pharyngeal reflux, documented with 3 site pharyngoesophageal pH monitoring, is higher among patients with posterior laryngitis and vocal cord lesions than control (78% vs. 21%). Most recently our cohort trial in over 80 patients with laryngeal findings suggestive of GERD suggested that vocal cord abnormalities such as granulomas may be more specific sign of GERD than any other (7). Thus, there is reasonable scientific intrigue regarding this laryngeal finding and the causal role from gastroesophagopharyngeal acid reflux requiring better studies. However, no study has evaluated the potential causal association between GERD and VCGs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with vocal cord granulomas
排除标准
- •Age < 18
- •Pregnancy
- •Use of proton pump inhibitor (PPI) within the last 30 days
研究组 & 干预措施
A 1
Arm I: placebo group receives BID placebo
干预措施: Esomeprazole (Drug)
A2
subjects receive active drug, esomeprazole 40 mg BID
干预措施: Esomeprazole (Drug)
结局指标
主要结局
• Primary outcome: Vocal cord granuloma improvement +/- resolution Outcome categories-subjectively assessed at laryngoscopy (current practice)
时间窗: 4 months
次要结局
- Symptom improvement +/- resolution(4 months)
研究者
Michael Vaezi
Principal Investigator
Vanderbilt University
