Lidocaine: Effect of Lidocaine in Chronic Cough

• ClinicalTrials.gov Identifier: NCT01252225
• Recruitment Status: Completed
• First Posted: December 2, 2010
• Last Update Posted: September 16, 2011
• Sponsor: Manchester University NHS Foundation Trust
• Information provided by (Responsible Party): Manchester University NHS Foundation Trust

Tracking Information

• First Submitted Date: November 29, 2010
• First Posted Date: December 2, 2010
• Last Update Posted Date: September 16, 2011
• Study Start Date: February 2011
• Actual Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Lidocaine: Effect of Lidocaine in Chronic Cough
• Official Title: 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: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment
• Condition: Chronic Cough

Intervention

• 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

• 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

Recruitment Information

• Recruitment Status: Completed
• Estimated Enrollment (submitted: November 30, 2010): 30
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: May 2011
• Actual Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United Kingdom

Administrative Information

• NCT Number: NCT01252225
• Other Study ID Numbers: Lidocaine1
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Manchester University NHS Foundation Trust
• Original Responsible Party: Professor Ashley Woodcock, University Hospital of South Manchester
• Current Study Sponsor: Manchester University NHS Foundation Trust
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Ashley Woodcock, MD, FRCP; University of Manchester

• PRS Account: Manchester University NHS Foundation Trust
• Verification Date: September 2011