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ISRCTN
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ISRCTN81877842
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ClinicalTrials.gov identifier
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Public title
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Safety of nebulised lignocaine in asthma
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Scientific title
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Acronym
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N/A
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Serial number at source
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RBF 96X33
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Study hypothesis
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1. To determine the effect of single doses of nebulised lignocaine (80 mg and 160 mg) on FEV1, bronchial reactivity, heart rate, blood pressure and plasma lignocaine levels over 2 hours in patients with relatively mild asthma
2. To determine whether any tendency to bronchoconstriction with nebulised lignocaine can be prevented by pre-treatment with salbutamol
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Respiratory tract diseases: Asthma
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Participants - inclusion criteria
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1. 20 patients aged 16 to 65 from the asthma research volunteers register.
2. They will have an forced expiratory volume in one second (FEV1) above 50% predicted, a history of asthma for at least 6 months (which is currently stable), at least 15% reversibility in FEV1 with 200 µg inhaled salbutamol, a PD20 methacholine, 12 µmol and they will be taking no treatment other than an inhaled steroid (up to 400 µg) and a short acting inhaled bronchodilator.
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Participants - exclusion criteria
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1. Any history of allergy to local anaesthetics, cardiac disease, epilepsy or other important medical condition
2. Women of child bearing age will only be included if surgically sterilised
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Anticipated start date
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01/02/1997
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Anticipated end date
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31/07/1997
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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20
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Interventions
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1. Placebo followed by 80 mg lignocaine
2. 2.5 mg salbutamol followed by 80 mg lignocaine
3. Placebo followed by placebo
4. Placebo followed by 160 mg lignocaine
5. 2.5 mg salbutamol followed by 160 mg lignocaine
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Primary outcome measure(s)
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Future work: if nebulised lignocaine can be confirmed to be safe and well tolerated either with or without pre-treatment with salbutamol the researchers intend to proceed with studies of regular treatment in subjects with more severe asthma to determine its steroid sparing effects.
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Secondary outcome measure(s)
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Not provided at time of registration
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Sources of funding
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NHS Executive Trent (UK)
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Trial website
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Publications
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1998 results in http://www.ncbi.nlm.nih.gov/pubmed/10197230
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Contact name
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Dr
Timothy
Harrison
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Address
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University of Nottingham
Division of Respiratory Medicine
Clinical Sciences Building
Hucknall Road
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City/town
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Nottingham
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Zip/Postcode
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NG5 1PB
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Country
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United Kingdom
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Tel
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+44 (0)115 960 3268
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Email
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Sponsor
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NHS R&D Regional Programme Register - Department of Health (UK)
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Address
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The Department of Health
Richmond House
79 Whitehall
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City/town
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London
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Zip/Postcode
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SW1A 2NL
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Country
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United Kingdom
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Tel
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+44 (0)20 7307 2622
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Fax
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+44 (0)20 7307 2623
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Email
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dhmail@doh.gsi.org.uk
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Sponsor website:
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http://www.doh.gov.uk
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Date applied
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23/01/2004
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Last edited
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09/12/2008
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Date ISRCTN assigned
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23/01/2004
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