Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
RBF 96X33
Study information
Scientific title
Acronym
Study hypothesis
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
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Not Specified
Patient information sheet
Condition
Respiratory tract diseases: Asthma
Intervention
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
Intervention type
Drug
Phase
Not Specified
Drug names
lignocaine, salbutamol
Primary outcome measures
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.
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/02/1997
Overall trial end date
31/07/1997
Reason abandoned
Eligibility
Participant inclusion criteria
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.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
20
Participant exclusion criteria
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
Recruitment start date
01/02/1997
Recruitment end date
31/07/1997
Locations
Countries of recruitment
United Kingdom
Trial participating centre
University of Nottingham
Nottingham
NG5 1PB
United Kingdom
Sponsor information
Organisation
NHS R&D Regional Programme Register - Department of Health (UK)
Sponsor details
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
NHS Executive Trent (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
1998 results in http://www.ncbi.nlm.nih.gov/pubmed/10197230
Publication citations
-
Results
Harrison TW, Tattersfield AE, Effect of single doses of inhaled lignocaine on FEV1 and bronchial reactivity in asthma., Respir Med, 1998, 92, 12, 1359-1363.