A comparison of intravenous salbutamol and aminophylline in the management of acute severe asthma in children
| ISRCTN | ISRCTN65396765 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN65396765 |
| Secondary identifying numbers | RDC01664 |
- Submission date
- 23/01/2004
- Registration date
- 23/01/2004
- Last edited
- 22/02/2008
- 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 Alex Habel
Scientific
Scientific
West Middlesex Hospital
Isleworth
TW7 6AF
United Kingdom
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | |
| Study objectives | To determine whether a bolus of intravenous salbutamol or an aminophylline infusion is the most effective therapy for children with acute severe asthma. |
| Ethics approval(s) | The study was approved by the Thames Multicentre Research ethics committee and the local ethics committees. |
| Health condition(s) or problem(s) studied | Asthma |
| Intervention | 1. Bolus of intravenous salbutamol 2. Aminophylline infusion |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Salbutamol, aminophylline |
| Primary outcome measure | Duration of the need for supplementary oxygen to maintain saturations of above 91%. |
| Secondary outcome measures | Other end points: 1. Asthma severity score two hours after starting intravenous therapy 2. Time to stopping intravenous therapy 3. Time to decision to discharge subject |
| Overall study start date | 10/01/2000 |
| Completion date | 10/01/2002 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 1 Year |
| Upper age limit | 15 Years |
| Sex | Both |
| Target number of participants | 44 |
| Key inclusion criteria | 1. Age 1 to 15 years 2. Acute severe asthma with an asthma severity score of greater than 7 3. Poor response to 3 "back to back" salbutamol/ipratropium nebulisers with an improvement in asthma severity score of less than 2 |
| Key exclusion criteria | 1. A life threatening exacerbation 2. An underlying respiratory disease other than asthma 3. Cardiac disease 4. Treatment with a medication that alters the metabolism of aminophylline |
| Date of first enrolment | 10/01/2000 |
| Date of final enrolment | 10/01/2002 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
West Middlesex Hospital
Isleworth
TW7 6AF
United Kingdom
TW7 6AF
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 |
|---|---|
| dhmail@doh.gsi.org.uk | |
| Website | http://www.doh.gov.uk |
Funders
Funder type
Government
NHS Executive London (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| 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? |
|---|---|---|---|---|---|
| Results article | Results | 01/04/2003 | Yes | No |
