Lidocaine: Effect of Lidocaine in Chronic Cough
|ClinicalTrials.gov Identifier: NCT01252225|
Recruitment Status : Completed
First Posted : December 2, 2010
Last Update Posted : September 16, 2011
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.
|Condition or disease||Intervention/treatment||Phase|
|Chronic Cough||Drug: 10 % Lidocaine Drug: 0.9% saline||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Effect of Lidocaine and Its Delivery in Patients With Chronic Cough|
|Study Start Date :||February 2011|
|Actual Primary Completion Date :||May 2011|
|Actual Study Completion Date :||May 2011|
|Active Comparator: Nebulised Lidocaine followed by Placebo throat spray||
Drug: 10 % Lidocaine
600 mg Nebulised Lidocaine ( 6 mls of 10 % Lidocaine) one-off dose
|Active Comparator: Nebulised Placebo followoed by Lidocaine Throat Spray||
Drug: 10 % Lidocaine
100 mg Lidocaine ( 1 ml of 10 % Lidocaine) given as one-off throat spray.
|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
- Objective cough counts over 10 hours post dose. Change in Urge to cough and Visual Analogue Score (VAS). [ Time Frame: over 24 hours following treatment ]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.
- Heart rate [ Time Frame: over 2 hours ]to document any change in heart rate after treatment
- Mouth Numbness [ Time Frame: over 24 hours following treatment ]Duration of mouth numbness will be subjectively assessed by asking patients about the presence of mouth numbness and its duration after treatment.
- Electrocardiogram (ECG) [ Time Frame: 15 minutes after treatment ]ECG will be recorded before treatment and 15 minutes after treatment to rule out any arrhythmias
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01252225
|University Hospital of South Manchester|
|Manchester, United Kingdom, M23 9LT|
|Principal Investigator:||Ashley Woodcock, MD, FRCP||University of Manchester|