Safety of nebulised lignocaine in asthma

ISRCTN	ISRCTN81877842
DOI	https://doi.org/10.1186/ISRCTN81877842
Protocol serial number	RBF 96X33
Sponsor	NHS R&D Regional Programme Register - Department of Health (UK)
Funder	NHS Executive Trent (UK)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

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

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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 / device / biological / vaccine name(s)	lignocaine, salbutamol
Primary outcome measure(s)	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.
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	31/07/1997

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	20
Key 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.
Key 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
Date of first enrolment	01/02/1997
Date of final enrolment	31/07/1997

University of Nottingham

Nottingham
NG5 1PB
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

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