Safety of nebulised lignocaine in asthma
ISRCTN | ISRCTN81877842 |
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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
Scientific
University of Nottingham
Division of Respiratory Medicine
Clinical Sciences Building
Hucknall Road
Nottingham
NG5 1PB
United Kingdom
Phone | +44 (0)115 960 3268 |
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Study information
Study design | Randomised controlled trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Not specified |
Study type | Not Specified |
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 |
Pharmaceutical study type(s) | |
Phase | Not Specified |
Drug / device / biological / vaccine name(s) | lignocaine, salbutamol |
Primary outcome measure | 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 study start date | 01/02/1997 |
Completion date | 31/07/1997 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Sex | Both |
Target number of participants | 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 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
University of Nottingham
Nottingham
NG5 1PB
United Kingdom
NG5 1PB
United Kingdom
Sponsor information
NHS R&D Regional Programme Register - Department of Health (UK)
Government
Government
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Phone | +44 (0)20 7307 2622 |
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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 | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan |
Study outputs
Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
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Results article | results | 01/12/1998 | Yes | No |