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

West Middlesex Hospital
Isleworth
TW7 6AF
United Kingdom

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific title
Study objectivesTo 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) studiedAsthma
Intervention1. Bolus of intravenous salbutamol
2. Aminophylline infusion
Intervention typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)Salbutamol, aminophylline
Primary outcome measureDuration of the need for supplementary oxygen to maintain saturations of above 91%.
Secondary outcome measuresOther 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 date10/01/2000
Completion date10/01/2002

Eligibility

Participant type(s)Patient
Age groupChild
Lower age limit1 Year
Upper age limit15 Years
SexBoth
Target number of participants44
Key inclusion criteria1. 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 criteria1. 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 enrolment10/01/2000
Date of final enrolment10/01/2002

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

West Middlesex Hospital
Isleworth
TW7 6AF
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 London (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 01/04/2003 Yes No