Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
RDC01664
Study information
Scientific title
Acronym
Study hypothesis
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
The study was approved by the Thames Multicentre Research ethics committee and the local ethics committees.
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Asthma
Intervention
1. Bolus of intravenous salbutamol
2. Aminophylline infusion
Intervention type
Drug
Phase
Not Specified
Drug names
Salbutamol, aminophylline
Primary outcome measures
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 trial start date
10/01/2000
Overall trial end date
10/01/2002
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
44
Participant 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
Recruitment start date
10/01/2000
Recruitment end date
10/01/2002
Locations
Countries of recruitment
United Kingdom
Trial participating centre
West Middlesex Hospital
Isleworth
TW7 6AF
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
Funders
Funder type
Government
Funder name
NHS Executive London (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
Results in http://www.ncbi.nlm.nih.gov/pubmed/12668792
Publication citations
-
Results
Roberts G, Newsom D, Gomez K, Raffles A, Saglani S, Begent J, Lachman P, Sloper K, Buchdahl R, Habel A, , Intravenous salbutamol bolus compared with an aminophylline infusion in children with severe asthma: a randomised controlled trial., Thorax, 2003, 58, 4, 306-310.