Lidocaine: Effect of Lidocaine in Chronic Cough

Chronic Cough Clinical Trial

Official title:

Effect of Lidocaine and Its Delivery in Patients With Chronic Cough

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01252225
• Other study ID #: Lidocaine1
• Status: Completed
• Phase: Phase 4
• First received: November 29, 2010
• Last updated: September 15, 2011
• Start date: February 2011
• Est. completion date: May 2011

Study information

• Verified date: September 2011
• Source: University Hospital of South Manchester NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: May 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Cough
• Cough

Intervention

Drug:
• 10 % Lidocaine
600 mg Nebulised Lidocaine ( 6 mls of 10 % Lidocaine) one-off dose
• 10 % Lidocaine
100 mg Lidocaine ( 1 ml of 10 % Lidocaine) given as one-off throat spray.
• 0.9% saline
6 mls of 0.9% saline nebulised followed by 1 ml of 0.9% saline as throat spray

Locations

Country	Name	City	State
United Kingdom	University Hospital of South Manchester	Manchester

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital of South Manchester NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Heart rate	to document any change in heart rate after treatment	over 2 hours	Yes
Secondary	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	No
Secondary	Electrocardiogram (ECG)	ECG will be recorded before treatment and 15 minutes after treatment to rule out any arrhythmias	15 minutes after treatment	Yes