Lidocaine: Effect of Lidocaine in Chronic Cough
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|ClinicalTrials.gov Identifier: NCT01252225|
Recruitment Status : Completed
First Posted : December 2, 2010
Last Update Posted : September 16, 2011
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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
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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.
- Current smokers
- Ex smokers with history of smoking > 20 pack years or those who have given up < 6 months ago.
- 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.
- 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
Central nervous system / Peripheral nervous system conditions:
- Myasthenia gravis.
- History of hepatic or renal dysfunction.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|
|Responsible Party:||Manchester University NHS Foundation Trust|
|Other Study ID Numbers:||
|First Posted:||December 2, 2010 Key Record Dates|
|Last Update Posted:||September 16, 2011|
|Last Verified:||September 2011|
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action