ISRCTN ISRCTN81877842
DOI https://doi.org/10.1186/ISRCTN81877842
Secondary identifying numbers RBF 96X33
Submission date
23/01/2004
Registration date
23/01/2004
Last edited
09/12/2008
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Respiratory
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Timothy Harrison
Scientific

University of Nottingham
Division of Respiratory Medicine
Clinical Sciences Building
Hucknall Road
Nottingham
NG5 1PB
United Kingdom

Phone +44 (0)115 960 3268

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeNot Specified
Scientific title
Study objectives1. 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(s)Not provided at time of registration
Health condition(s) or problem(s) studiedRespiratory tract diseases: Asthma
Intervention1. 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 typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)lignocaine, salbutamol
Primary outcome measureFuture 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 measuresNot provided at time of registration
Overall study start date01/02/1997
Completion date31/07/1997

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants20
Key inclusion criteria1. 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.
Key exclusion criteria1. 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
Date of first enrolment01/02/1997
Date of final enrolment31/07/1997

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

University of Nottingham
Nottingham
NG5 1PB
United Kingdom

Sponsor information

NHS R&D Regional Programme Register - Department of Health (UK)
Government

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Phone +44 (0)20 7307 2622
Email dhmail@doh.gsi.org.uk
Website http://www.doh.gov.uk

Funders

Funder type

Government

NHS Executive Trent (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/12/1998 Yes No