Effect of Lidocaine and Its Delivery in Patients With Chronic Cough
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Objective cough counts over 10 hours post dose. Change in Urge to cough and Visual Analogue Score (VAS).
研究概览
简要总结
People cough in order to clear their airways. Most coughs are caused by viruses and settle down by themselves, but some people develop persistent coughing which can be anywhere from 8 weeks to several years. This is called chronic cough. People with chronic cough find the symptom distressing and it can have a major impact on their quality of life. Patients with chronic cough often report a sensation at the back of their throat which makes them feel an urge to cough. There is some evidence that Lidocaine (an anaesthetic used during medical procedures) can suppress a person's cough when given to patients via a nebuliser (a machine that turns liquid into a fine mist).
It is currently unknown whether using a local anaesthetic, such as Lidocaine, in the form of a throat spray would successfully suppress a person's cough. A throat spray would be an easier treatment option in chronic cough patients. Thus, the investigators research aims to compare cough rates, severity and urge to cough scores between Lidocaine throat spray and nebulised Lidocaine.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 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
- 否
入选标准
- •Male and female subjects, age 18 years and over.
- •History of cough for more than 8 weeks.
- •Normal chest x ray
- •Chronic idiopathic cough or chronic cough resistant to treatment of specific triggers.
排除标准
- •Smoking status:
- •Current smokers
- •Ex smokers with history of smoking > 20 pack years or those who have given up < 6 months ago.
- •Prohibited medications:
- •Use of medications likely to suppress / affect cough including codeine, morphine, pregabalin, gabapentin, amitriptylline, angiotensin converting enzyme inhibitors (type 1) and baclofen.
- •Use of any anti-arrhythmic medication.
- •Use of cimetidine, beta blockers, or diuretics.
- •Cardiovascular conditions:
- •Sinoatrial disease, bradycardia or all types of heart blocks.
- •History of ischaemic heart disease or heart failure.
- •Clinically significant abnormal electrocardiogram (ECG) at Screening or Baseline.
- •History of cardiac surgery
- •Respiratory conditions:
- •Central nervous system / Peripheral nervous system conditions:
- •Epilepsy.
- •Myasthenia gravis.
- •Miscellaneous:
- •History of hepatic or renal dysfunction.
- •Porphyria
- •History of hypersensitivity to Lidocaine or related drugs.
- •Pregnancy or breast feeding.
- •Participation in another trial within the preceding 6 weeks.
- •Trauma or ulceration to oral mucosa.
- •History of chest or upper airway infection within the past 6 weeks.
- •Conditions which may affect cough response such as stroke, diabetes, Parkinson's Disease.
研究组 & 干预措施
Nebulised Lidocaine followed by Placebo throat spray
干预措施: 10 % Lidocaine (Drug)
Nebulised Placebo followoed by Lidocaine Throat Spray
干预措施: 10 % Lidocaine (Drug)
Nebulised placebo followed by placebo throat spray
干预措施: 0.9% saline (Drug)
结局指标
主要结局
Objective cough counts over 10 hours post dose. Change in Urge to cough and Visual Analogue Score (VAS).
时间窗: over 24 hours following treatment
patients will wear a cough recorder device for a 24 hour period. The recordings will then be analysed to reveal how many times the patient coughed.
次要结局
- Heart rate(over 2 hours)
- Mouth Numbness(over 24 hours following treatment)
- Electrocardiogram (ECG)(15 minutes after treatment)