Don't get left behind! The modernized is coming. Check it out now.
Say goodbye to!
The new site is coming soon - go to the modernized
Working… Menu

Lidocaine: Effect of Lidocaine in Chronic Cough

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01252225
Recruitment Status : Completed
First Posted : December 2, 2010
Last Update Posted : September 16, 2011
Information provided by (Responsible Party):
Manchester University NHS Foundation Trust

Tracking Information
First Submitted Date  ICMJE November 29, 2010
First Posted Date  ICMJE December 2, 2010
Last Update Posted Date September 16, 2011
Study Start Date  ICMJE February 2011
Actual Primary Completion Date May 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 30, 2010)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 30, 2010)
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Lidocaine: Effect of Lidocaine in Chronic Cough
Official Title  ICMJE Effect of Lidocaine and Its Delivery in Patients With Chronic Cough
Brief Summary

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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Chronic Cough
Intervention  ICMJE
  • Drug: 10 % Lidocaine
    600 mg Nebulised Lidocaine ( 6 mls of 10 % Lidocaine) one-off dose
    Other Names:
    • Lidocaine
    • Lignocaine
  • Drug: 10 % Lidocaine
    100 mg Lidocaine ( 1 ml of 10 % Lidocaine) given as one-off throat spray.
    Other Names:
    • Lidocaine
    • Lignocaine
  • Drug: 0.9% saline
    6 mls of 0.9% saline nebulised followed by 1 ml of 0.9% saline as throat spray
Study Arms  ICMJE
  • Active Comparator: Nebulised Lidocaine followed by Placebo throat spray
    Intervention: Drug: 10 % Lidocaine
  • Active Comparator: Nebulised Placebo followoed by Lidocaine Throat Spray
    Intervention: Drug: 10 % Lidocaine
  • Placebo Comparator: Nebulised placebo followed by placebo throat spray
    Intervention: Drug: 0.9% saline
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: November 30, 2010)
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 2011
Actual Primary Completion Date May 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT01252225
Other Study ID Numbers  ICMJE Lidocaine1
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Manchester University NHS Foundation Trust
Original Responsible Party Professor Ashley Woodcock, University Hospital of South Manchester
Current Study Sponsor  ICMJE Manchester University NHS Foundation Trust
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Ashley Woodcock, MD, FRCP University of Manchester
PRS Account Manchester University NHS Foundation Trust
Verification Date September 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP