Chronic Cough
Conditions
Interventions
Product Name: Lidocaine
Pharmaceutical Form: Nebuliser solution
INN or Proposed INN: Lidocaine
Concentration unit: % (W/V) percent weight/volume
Concentration type: equal
Concentration number: 10-
Pr
Sponsors
University Hospital of South Manchester
Eligibility
Sex/Gender
All
Inclusion 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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range ;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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: SMOKING STATUS: - Current smokers - Ex smokers with history of smoking > 20 pack years or those who have given up 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 convertin 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: - Asthma. CENTRAL/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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To study and compare the effect of throat spray Lidocaine and nebulised Lidocaine on the number of cough counts* in 24 hours. *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 Objective: 1. To study the effect of throat spray Lidocaine on the perception* of the urge to cough; 2. Compare the effect of throat spray Lidocaine with matching placebo on cough; 3. Compare the effect of nebulised Lidocaine with matching placebo on cough. *perception of the urge to cough is recorded using short a questionnaire.;Primary end point(s): - Objective cough counts over 10hr post dose - Change in urge to cough and visual analogue score;Main Objective: To study and compare the effect of throat spray Lidocaine and nebulised Lidocaine on the number of cough counts* in 24 hours. *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 Objective: 1. To study the effect of throat spray Lidocaine on the perception* of the urge to cough; 2. Compare the effect of throat spray Lidocaine with matching placebo on cough; 3. Compare the effect of nebulised Lidocaine with matching placebo on cough. *perception of the urge to cough is recorded using short a questionnaire.;Primary end point(s): - Objective cough counts over 10hr post dose - Change in urge to cough and visual analogue score | — |
Countries
United Kingdom
Contacts
Public Contact; ;
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Outcome results
None listed