- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01252225
Lidocaine: Effect of Lidocaine in Chronic Cough
Effect of Lidocaine and Its Delivery in Patients With Chronic Cough
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
-
Manchester, United Kingdom, M23 9LT
- University Hospital of South Manchester
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Nebulised Lidocaine followed by Placebo throat spray
|
600 mg Nebulised Lidocaine ( 6 mls of 10 % Lidocaine) one-off dose
Other Names:
100 mg Lidocaine ( 1 ml of 10 % Lidocaine) given as one-off throat spray.
Other Names:
|
Active Comparator: Nebulised Placebo followoed by Lidocaine Throat Spray
|
600 mg Nebulised Lidocaine ( 6 mls of 10 % Lidocaine) one-off dose
Other Names:
100 mg Lidocaine ( 1 ml of 10 % Lidocaine) given as one-off throat spray.
Other Names:
|
Placebo Comparator: Nebulised placebo followed by placebo throat spray
|
6 mls of 0.9% saline nebulised followed by 1 ml of 0.9% saline as throat spray
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
over 24 hours following treatment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Heart rate
Time Frame: over 2 hours
|
to document any change in heart rate after treatment
|
over 2 hours
|
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.
|
over 24 hours following 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
|
15 minutes after treatment
|
Collaborators and Investigators
Investigators
- Principal Investigator: Ashley Woodcock, MD, FRCP, University of Manchester
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Respiration Disorders
- Signs and Symptoms, Respiratory
- Cough
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Arrhythmia Agents
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Sensory System Agents
- Anesthetics
- Membrane Transport Modulators
- Anesthetics, Local
- Voltage-Gated Sodium Channel Blockers
- Sodium Channel Blockers
- Lidocaine
Other Study ID Numbers
- Lidocaine1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Chronic Cough
-
Trevi TherapeuticsRecruitingRefractory Chronic CoughCanada, United Kingdom
-
Mayo ClinicRecruitingRefractory Chronic CoughUnited States
-
Guangzhou Medical UniversityNingbo SensCure Biotechnology Co., Ltd.Recruiting
-
Stuart MazzoneMelbourne Health; Merck Sharp & Dohme LLC; Monash UniversityRecruitingChronic CoughAustralia
-
ShionogiCompletedChronic CoughUnited States, United Kingdom, Japan, Ukraine, Poland, Czechia
-
Respivant Sciences GmbHRespivant Sciences Inc.TerminatedChronic Cough | IPF | Persistent Cough in IPFUnited States, United Kingdom, Netherlands, Australia, Belgium, New Zealand, Turkey, Italy, Germany, Czechia, Canada
-
Genentech, Inc.RecruitingChronic Refractory Cough (CRC) With Non-atopic Asthma | CRC With Atopic Asthma | Unexplained Chronic Cough | CRC With Chronic Obstructive Pulmonary Disease | CRC With Chronic Obstructive Pulmonary Disease With Chronic BronchitisUnited States, Australia, United Kingdom, Canada
-
Merck Sharp & Dohme LLCCompletedChronic CoughCanada, Czechia, Denmark, Hungary, Peru, Poland, Ukraine, United Kingdom, United States, Australia, China, Colombia, Germany, Guatemala, Israel, Italy, Malaysia, New Zealand, South Africa, Turkey
-
Hull University Teaching Hospitals NHS TrustRecruitingChronic CoughUnited Kingdom
Clinical Trials on 10 % Lidocaine
-
Monash UniversityRoyal Perth HospitalRecruitingBreast Cancer | Mastectomy | Breast Cancer Female | Breast Conserving SurgeryAustralia, New Zealand, Hong Kong
-
Khon Kaen UniversityCompleted
-
Khon Kaen UniversityNot yet recruitingIntubation | Hemodynamics | Laryngoscopy | Neurosurgery | LidocaineThailand
-
Shiraz University of Medical SciencesCompletedInterferential Current Drug DeliveryIran, Islamic Republic of
-
Yeditepe UniversityCompletedLocal Anesthesia | Cannula Site PainTurkey
-
Northwestern UniversityRecruiting
-
All India Institute of Medical Sciences, New DelhiUnknownAnesthesia, Local | BronchoscopyIndia
-
Mahidol UniversityCompletedAbnormal Uterine Bleeding | Endometrial BiopsyThailand
-
Nordsjaellands HospitalInnovation Fund DenmarkCompleted
-
Cairo UniversityNot yet recruiting