Skip to main content
OpenTrials
Completed

NCT Number: NCT01252225

Lidocaine: Effect of Lidocaine in Chronic Cough

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University Hospital of South Manchester

Manchester, M23 9LT, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

10 % Lidocaine

Drug

600 mg Nebulised Lidocaine ( 6 mls of 10 % Lidocaine) one-off dose

Other names: Lidocaine, Lignocaine

0.9% saline

Drug

6 mls of 0.9% saline nebulised followed by 1 ml of 0.9% saline as throat spray

Primary outcomes

  1. 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.

Secondary outcomes

  1. Heart rate

    Time frame: over 2 hours

    to document any change in heart rate after treatment

  2. 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.

  3. Electrocardiogram (ECG)

    Time frame: 15 minutes after treatment

    ECG will be recorded before treatment and 15 minutes after treatment to rule out any arrhythmias

Sponsors and collaborators

Lead sponsor

Manchester University NHS Foundation Trust

Other Gov

Registry information

Official study title

Effect of Lidocaine and Its Delivery in Patients With Chronic Cough

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Dec 2, 2010
Registry last updated
Sep 16, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.