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Lidocaine: Effect of Lidocaine in Chronic Cough

Primary Purpose

Chronic Cough

Status

Completed

Phase

Phase 4

Locations

United Kingdom

Study Type

Interventional

Intervention

10 % Lidocaine

0.9% saline

About this trial

This is an interventional treatment trial for Chronic Cough focused on measuring Chronic Cough, Lidocaine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

University Hospital of South Manchester

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Nebulised Lidocaine followed by Placebo throat spray

Nebulised Placebo followoed by Lidocaine Throat Spray

Nebulised placebo followed by placebo throat spray

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Heart rate

to document any change in heart rate after treatment

Mouth Numbness

Duration of mouth numbness will be subjectively assessed by asking patients about the presence of mouth numbness and its duration after treatment.

Electrocardiogram (ECG)

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

Full Information

NCT ID

NCT01252225

First Posted

November 29, 2010

Last Updated

September 15, 2011

Sponsor

Manchester University NHS Foundation Trust

1. Study Identification

Unique Protocol Identification Number

NCT01252225

Brief Title

Lidocaine: Effect of Lidocaine in Chronic Cough

Official Title

Effect of Lidocaine and Its Delivery in Patients With Chronic Cough

Study Type

Interventional

2. Study Status

Record Verification Date

September 2011

Overall Recruitment Status

Completed

Study Start Date

February 2011 (undefined)

Primary Completion Date

May 2011 (Actual)

Study Completion Date

May 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Manchester University NHS Foundation Trust

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Cough

Keywords

Chronic Cough, Lidocaine

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Crossover Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Nebulised Lidocaine followed by Placebo throat spray

Arm Type

Active Comparator

Arm Title

Nebulised Placebo followoed by Lidocaine Throat Spray

Arm Type

Active Comparator

Arm Title

Nebulised placebo followed by placebo throat spray

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

10 % Lidocaine

Other Intervention Name(s)

Lidocaine, Lignocaine

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

10 % Lidocaine

Other Intervention Name(s)

Lidocaine, Lignocaine

Intervention Description

100 mg Lidocaine ( 1 ml of 10 % Lidocaine) given as one-off throat spray.

Intervention Type

Drug

Intervention Name(s)

0.9% saline

Intervention Description

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

Primary Outcome Measure Information:

Title

Objective cough counts over 10 hours post dose. Change in Urge to cough and Visual Analogue Score (VAS).

Description

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 Outcome Measure Information:

Title

Heart rate

Description

to document any change in heart rate after treatment

Time Frame

over 2 hours

Title

Mouth Numbness

Description

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

Title

Electrocardiogram (ECG)

Description

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

Time Frame

15 minutes after treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ashley Woodcock, MD, FRCP

Organizational Affiliation

University of Manchester

Official's Role

Principal Investigator

Facility Information:

Facility Name

University Hospital of South Manchester

City

Manchester

ZIP/Postal Code

M23 9LT

Country

United Kingdom

12. IPD Sharing Statement

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Lidocaine: Effect of Lidocaine in Chronic Cough

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