Condition category
Respiratory
Date applied
23/01/2004
Date assigned
23/01/2004
Last edited
09/12/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Timothy Harrison

ORCID ID

Contact details

University of Nottingham
Division of Respiratory Medicine
Clinical Sciences Building
Hucknall Road
Nottingham
NG5 1PB
United Kingdom
+44 (0)115 960 3268

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

http://www.doh.gov.uk

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

  1. 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.

Additional files

Editorial Notes