Lidocaine: Effect of Lidocaine in Chronic Cough

Effect of Lidocaine and Its Delivery in Patients With Chronic Cough

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 Overview

• Status: Completed
• Conditions: Chronic Cough
• Intervention / Treatment: Drug: 10 % Lidocaine; Drug: 10 % Lidocaine; Drug: 0.9% saline

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Phase 4

Contacts and Locations

Study Locations

• United Kingdom
  • Manchester, United Kingdom, M23 9LT
    • University Hospital of South Manchester

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Manchester University NHS Foundation Trust
• Investigators: Principal Investigator: Ashley Woodcock, MD, FRCP, University of Manchester

Study record dates

Study Major Dates

• Study Start: February 1, 2011
• Primary Completion (Actual): May 1, 2011
• Study Completion (Actual): May 1, 2011

Study Registration Dates

• First Submitted: November 29, 2010
• First Submitted That Met QC Criteria: November 30, 2010
• First Posted (Estimate): December 2, 2010

Study Record Updates

• Last Update Posted (Estimate): September 16, 2011
• Last Update Submitted That Met QC Criteria: September 15, 2011
• Last Verified: September 1, 2011

More Information

Terms related to this study

• Keywords: Lidocaine; Chronic Cough
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Cough; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Lidocaine
• Other Study ID Numbers: Lidocaine1