Lidocaine: Effect of Lidocaine in Chronic Cough
This study has been completed.
Sponsor:
University Hospital of South Manchester NHS Foundation Trust
Information provided by (Responsible Party):
University Hospital of South Manchester NHS Foundation Trust
ClinicalTrials.gov Identifier:
NCT01252225
First received: November 29, 2010
Last updated: September 15, 2011
Last verified: September 2011
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Chronic Cough |
Drug: 10 % Lidocaine Drug: 0.9% saline |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | Effect of Lidocaine and Its Delivery in Patients With Chronic Cough |
Resource links provided by NLM:
Further study details as provided by University Hospital of South Manchester NHS Foundation Trust:
Primary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]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.
Secondary Outcome Measures:
- Heart rate [ Time Frame: over 2 hours ] [ Designated as safety issue: Yes ]to document any change in heart rate after treatment
- Mouth Numbness [ Time Frame: over 24 hours following treatment ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: Yes ]ECG will be recorded before treatment and 15 minutes after treatment to rule out any arrhythmias
| Estimated Enrollment: | 30 |
| Study Start Date: | February 2011 |
| Study Completion Date: | May 2011 |
| Primary Completion Date: | May 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: Nebulised Lidocaine followed by Placebo throat spray |
Drug: 10 % Lidocaine
600 mg Nebulised Lidocaine ( 6 mls of 10 % Lidocaine) one-off dose
Other Names:
|
| 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.
Other Names:
|
| 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
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01252225
Locations
| United Kingdom | |
| University Hospital of South Manchester | |
| Manchester, United Kingdom, M23 9LT | |
Sponsors and Collaborators
University Hospital of South Manchester NHS Foundation Trust
Investigators
| Principal Investigator: | Ashley Woodcock, MD, FRCP | University of Manchester |
More Information
No publications provided
| Responsible Party: | University Hospital of South Manchester NHS Foundation Trust |
| ClinicalTrials.gov Identifier: | NCT01252225 History of Changes |
| Other Study ID Numbers: | Lidocaine1 |
| Study First Received: | November 29, 2010 |
| Last Updated: | September 15, 2011 |
| Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency |
Keywords provided by University Hospital of South Manchester NHS Foundation Trust:
|
Chronic Cough Lidocaine |
Additional relevant MeSH terms:
|
Cough Respiration Disorders Respiratory Tract Diseases Signs and Symptoms, Respiratory Signs and Symptoms Lidocaine Anesthetics, Local Anesthetics Central Nervous System Depressants |
Physiological Effects of Drugs Pharmacologic Actions Sensory System Agents Peripheral Nervous System Agents Central Nervous System Agents Therapeutic Uses Anti-Arrhythmia Agents Cardiovascular Agents |
ClinicalTrials.gov processed this record on June 18, 2013