Lidocaine: Effect of Lidocaine in Chronic Cough

NCT ID: NCT01252225

Last Updated: 2011-09-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-02-28
• Study Completion Date: 2011-05-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Nebulised Lidocaine followed by Placebo throat spray

Group Type: ACTIVE_COMPARATOR

10 % Lidocaine

Intervention Type: DRUG

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

Nebulised Placebo followoed by Lidocaine Throat Spray

Group Type: ACTIVE_COMPARATOR

10 % Lidocaine

Intervention Type: DRUG

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

Nebulised placebo followed by placebo throat spray

Group Type: PLACEBO_COMPARATOR

0.9% saline

Intervention Type: DRUG

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

Interventions

10 % Lidocaine

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

Intervention Type: DRUG

10 % Lidocaine

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

Intervention Type: DRUG

0.9% saline

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

Intervention Type: DRUG

Other Intervention Names

Lidocaine; Lignocaine; Lidocaine; Lignocaine

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Manchester University NHS Foundation Trust

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ashley Woodcock, MD, FRCP

Role: PRINCIPAL_INVESTIGATOR

University of Manchester

Locations

University Hospital of South Manchester

Manchester, , United Kingdom

Countries

United Kingdom

Other Identifiers

Lidocaine1

Identifier Type: -

Identifier Source: org_study_id