Lidocaine: Effect of Lidocaine in Chronic Cough

Study Overview
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Brief Summary
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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.

Official Title
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Effect of Lidocaine and Its Delivery in Patients With Chronic Cough

Conditions
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Chronic Cough

Intervention / Treatment
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* Drug: 10 % Lidocaine
* Drug: 10 % Lidocaine
* Drug: 0.9% saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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: o Asthma. 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Nebulised Lidocaine followed by Placebo throat spray<br> | Drug: 10 % Lidocaine<br>* 600 mg Nebulised Lidocaine ( 6 mls of 10 % Lidocaine) one-off dose<br>* Other names: Lignocaine;|
| Active Comparator: Nebulised Placebo followoed by Lidocaine Throat Spray<br> | Drug: 10 % Lidocaine<br>* 100 mg Lidocaine ( 1 ml of 10 % Lidocaine) given as one-off throat spray.<br>* Other names: Lignocaine;|
| Placebo Comparator: Nebulised placebo followed by placebo throat spray<br> | Drug: 0.9% saline<br>* 6 mls of 0.9% saline nebulised followed by 1 ml of 0.9% saline as throat spray<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective cough counts over 10 hours post dose. Change in Urge to cough and Visual Analogue Score (VAS). | 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. | over 24 hours following treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Heart rate | to document any change in heart rate after treatment | over 2 hours | 
| Mouth Numbness | Duration of mouth numbness will be subjectively assessed by asking patients about the presence of mouth numbness and its duration after treatment. | over 24 hours following treatment | 
| Electrocardiogram (ECG) | ECG will be recorded before treatment and 15 minutes after treatment to rule out any arrhythmias | 15 minutes after treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic Cough, Lidocaine