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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nebulised Lidocaine followed by Placebo throat spray | Active Comparator |
| |
| Nebulised Placebo followoed by Lidocaine Throat Spray | Active Comparator |
| |
| Nebulised placebo followed by placebo throat spray | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 10 % Lidocaine | Drug | 600 mg Nebulised Lidocaine ( 6 mls of 10 % Lidocaine) one-off dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Heart rate | to document any change in heart rate after treatment | over 2 hours |
| Mouth Numbness | Duration of mouth numbness will be subjectively assessed by asking patients about the presence of mouth numbness and its duration after treatment. |
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Inclusion Criteria:
Exclusion Criteria:
Smoking status:
Prohibited medications:
Cardiovascular conditions:
Respiratory conditions:
o Asthma.
Central nervous system / Peripheral nervous system conditions:
Miscellaneous:
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| Name | Affiliation | Role |
|---|---|---|
| Ashley Woodcock, MD, FRCP | University of Manchester | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital of South Manchester | Manchester | M23 9LT | United Kingdom |
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| ID | Term |
|---|---|
| D000096822 | Chronic Cough |
| ID | Term |
|---|---|
| D003371 | Cough |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D012818 | Signs and Symptoms, Respiratory |
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| ID | Term |
|---|---|
| D008012 | Lidocaine |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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| 10 % Lidocaine | Drug | 100 mg Lidocaine ( 1 ml of 10 % Lidocaine) given as one-off throat spray. |
|
|
| 0.9% saline | Drug | 6 mls of 0.9% saline nebulised followed by 1 ml of 0.9% saline as throat spray |
|
| over 24 hours following treatment |
| Electrocardiogram (ECG) | ECG will be recorded before treatment and 15 minutes after treatment to rule out any arrhythmias | 15 minutes after treatment |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Aniline Compounds |
| D000588 | Amines |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |