Condition category
Respiratory
Date applied
23/01/2004
Date assigned
23/01/2004
Last edited
22/02/2008
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 Alex Habel

ORCID ID

Contact details

West Middlesex Hospital
Isleworth
TW7 6AF
United Kingdom

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

http://www.doh.gov.uk

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

  1. 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.

Additional files

Editorial Notes