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ISRCTN
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ISRCTN65396765
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ClinicalTrials.gov identifier
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Public title
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A comparison of intravenous salbutamol and aminophylline in the management of acute severe asthma in children
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Scientific title
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Acronym
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N/A
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Serial number at source
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RDC01664
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Study hypothesis
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To determine whether a bolus of intravenous salbutamol or an aminophylline infusion is the most effective therapy for children with acute severe asthma.
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Lay summary
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Ethics approval
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The study was approved by the Thames Multicentre Research ethics committee and the local ethics committees.
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Study design
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Randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Asthma
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Participants - inclusion criteria
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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
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Participants - exclusion criteria
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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
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Anticipated start date
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10/01/2000
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Anticipated end date
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10/01/2002
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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44
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Interventions
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1. Bolus of intravenous salbutamol
2. Aminophylline infusion
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Primary outcome measure(s)
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Duration of the need for supplementary oxygen to maintain saturations of above 91%.
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Secondary outcome measure(s)
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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
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Sources of funding
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NHS Executive London (UK)
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Trial website
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Publications
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Results in http://www.ncbi.nlm.nih.gov/pubmed/12668792
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Contact name
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Dr
Alex
Habel
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Address
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West Middlesex Hospital
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City/town
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Isleworth
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Zip/Postcode
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TW7 6AF
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Country
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United Kingdom
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Sponsor
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NHS R&D Regional Programme Register - Department of Health (UK)
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Address
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The Department of Health
Richmond House
79 Whitehall
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City/town
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London
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Zip/Postcode
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SW1A 2NL
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Country
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United Kingdom
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Tel
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+44 (0)20 7307 2622
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Fax
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+44 (0)20 7307 2623
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Email
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dhmail@doh.gsi.org.uk
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Sponsor website:
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http://www.doh.gov.uk
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Date applied
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23/01/2004
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Last edited
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22/02/2008
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Date ISRCTN assigned
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23/01/2004
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