Pilot Study Investigating Central Sensitisation of the Cough Reflex in Subjects With Chronic Cough and Healthy Volunteers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- Effect of oesophageal acid infusion on cough reflex sensitivity in chronic cough patients compared to healthy controls.
研究概览
简要总结
Central sensitisation is an increase in the excitability of nerves within the central nervous system, which can lead to heightened sensitivity to certain stimuli. This process is involved in some chronic pain conditions e.g. migraines and non-cardiac chest pain. Recent work by our group suggests central sensitisation may be an important mechanism leading to chronic cough.
The main questions in this study include:
- Can the investigators induce temporary central sensitisation of the cough reflex in healthy volunteers for testing of new medications?
- Can the investigators demonstrate exaggerated sensitisation in patients with chronic cough (indicating these patients are already centrally sensitised)?
In animal studies, acid infusion into the gullet (oesophagus) is able to induce central sensitisation of the cough reflex. Acid infusion into the oesophagus has also been shown to induce central sensitisation in human healthy volunteers, increasing the sensitivity to pain on the front of the chest but this study did not test the the cough reflex. Using human participants, the investigators plan to test whether acid infusion into the oesophagus increases the sensitivity of the cough reflex in healthy volunteers and also patients complaining of chronic cough.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
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
- •Healthy volunteers inclusion:
- •Over 18 years
- •Measurable cough reflex sensitivity - required as is the primary end-point
- •No current or past history of chronic cough or chronic respiratory disease
- •Chronic Cough Patients inclusion:
- •Over 18 years
- •Chronic persistent cough (> 8 weeks) despite investigation and/or treatment trials for cough variant asthma/post-nasal drip and gastro-oesophageal reflux
- •Normal chest radiograph - primary respiratory cause for cough excluded
- •Normal lung function - primary respiratory cause for cough excluded Measurable cough reflex sensitivity - required as primary end-point
排除标准
- •Recent upper respiratory tract infection (<4 weeks) - this can lead to increased sensitivity of the cough reflex which resolves as the infection settles
- •Pregnancy/breast-feeding - unknown effects of oesophageal acid infusion
- •Current smokers or ex-smokers with < 6 month abstinence or history > 20 pack years - smoking can alter the sensitivity of the cough reflex
- •Opiate or ACE inhibitor use or centrally acting medication - can alter the cough reflex sensitivity
- •Symptomatic gastro-oesophageal reflux, post-nasal drip or asthma (chronic cough cohort may have been treated for these in the past but cough did not resolve) - these conditions are known to cause cough and alter cough reflex sensitivity
- •Significant ongoing chronic respiratory/cardiovascular/gastro-intestinal/haematological/ neurological/psychiatric illness. We are aiming to recruit healthy volunteers and chronic cough patients who are otherwise healthy
研究组 & 干预措施
Hydrochloric acid infusion
干预措施: Hydrochloric acid (0.15 molar) (Other)
Saline
干预措施: Saline (Other)
结局指标
主要结局
Effect of oesophageal acid infusion on cough reflex sensitivity in chronic cough patients compared to healthy controls.
时间窗: baseline, immediatley after infusion, 90 minutes post infusion, 180 minutes post infusion, 24 hours after baseline
Outcome measures include; cough reflex sensitivity, pain threshold measures, 24 hour objective cough rate
次要结局
未报告次要终点
研究者
Jacky Smith
MRC Clinician Scientist/Honorary Respiratory Consultant
University of Manchester