Lidocaine: Effect of Lidocaine in Chronic Cough

Manchester University NHS Foundation Trust30 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Chronic Cough

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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.

Time frame: over 24 hours following treatment

Secondary Outcomes

Heart rate

to document any change in heart rate after treatment

Time frame: 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.

Time frame: over 24 hours following treatment

Electrocardiogram (ECG)

ECG will be recorded before treatment and 15 minutes after treatment to rule out any arrhythmias

Time frame: 15 minutes after treatment