Lidocaine: Effect of Lidocaine in Chronic Cough

NCT01252225 | Completed Phase 4

• 1 other identifier: Lidocaine1
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Cough

Keywords

Chronic Cough; Lidocaine

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Heart rate

  over 2 hours

• Mouth Numbness

  over 24 hours following treatment

• Electrocardiogram (ECG)

  15 minutes after treatment

Study Arms (3)

Nebulised Lidocaine followed by Placebo throat spray

ACTIVE COMPARATOR

Drug: 10 % Lidocaine

Nebulised Placebo followoed by Lidocaine Throat Spray

ACTIVE COMPARATOR

Drug: 10 % Lidocaine

Nebulised placebo followed by placebo throat spray

PLACEBO COMPARATOR

Drug: 0.9% saline

Interventions

10 % Lidocaine DRUG

600 mg Nebulised Lidocaine ( 6 mls of 10 % Lidocaine) one-off dose

Also known as: Lidocaine, Lignocaine

Nebulised Lidocaine followed by Placebo throat spray

0.9% saline DRUG

6 mls of 0.9% saline nebulised followed by 1 ml of 0.9% saline as throat spray

Nebulised placebo followed by placebo throat spray

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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:

Sponsors & Collaborators

• Manchester University NHS Foundation Trust: lead

Study Sites (1)

University Hospital of South Manchester

Manchester, M23 9LT, United Kingdom

Location

MeSH Terms

Conditions

Chronic Cough

Interventions

Lidocaine; Saline Solution

Condition Hierarchy (Ancestors)

Cough; Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Ashley Woodcock, MD, FRCP

  University of Manchester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 29, 2010
• First Posted: December 2, 2010
• Study Start: February 1, 2011
• Primary Completion: May 1, 2011
• Study Completion: May 1, 2011
• Last Updated: September 16, 2011

Record last verified: 2011-09

Locations

GB (1)