Efficacy of Superior Laryngeal Nerve Block for Chronic Cough
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 17
- 试验地点
- 2
- 主要终点
- Change in Cough Severity
研究概览
简要总结
This is a research study to find out if superior laryngeal nerve blocks are an effective way to reduce cough when compared to placebo (a substance without any medical value). Eligibility for the study include the following: age >18, cough history suggestive that the nerve to the voice box is overactive, non-smoker, Patients will be followed over time and assigned to either the treatment or placebo group at random. The treatment would be four superior laryngeal nerve blocks and the placebo would be four saline injections (the inactive substance). Study team will measure if the injection improved cough and ask patients to keep a log of symptoms and fill out questionnaires at each visit. After the four injections, patients will follow up in 3 months to see if cough has returned and if so, how severe the cough is.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •History consistent with neurogenic cough
- •Exclusion of other etiologies (see exclusion criteria)
排除标准
- •Current neuromodulating medication use
- •Untreated other etiologies of cough:
- •Current smoker Current ACE/ARB use Abnormal PFTs within 6 months Uncontrolled OSA Abnormal CXR within 6 months RSI > 13 or RFS >11 AND workup positive for GERD (esophagram, 24-hour pH probe, manometry, EGD)
结局指标
主要结局
Change in Cough Severity
时间窗: Change from Baseline to 3 months
Patient will complete the Leicester Cough Questionnaire at each visit. This is a validated survey that measures 3 domains (physical, psychological and social). The total score range is 3-21 and domain scores range from 1-7; a higher score indicates a better quality of life.
次要结局
- Subjective Improvement in Cough(Baseline, 1-4 weeks post-injection, and 3 months post-treatment)
- Summed Daily Change in Subjective Cough Severity(Daily for 3 months post-injection)