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ISRCTN
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ISRCTN00922609
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ClinicalTrials.gov identifier
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Public title
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Assessment of long-term efficacy of early introduction of inhaled steroids in asthma
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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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HTA 93/14/06
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Study hypothesis
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We propose to study the effect of introducing inhaled steroids in children and adults at the time of asthma diagnosis in a randomised controlled trial of parallel group design. The study will be conducted through the MRC General Practice Research Framework, which is currently carrying out another large asthma study with the National Asthma Task Force Therapy Working Group.
A 21-month feasibility study is proposed in 12-16 practices within the General Practice Research Framework. 100 patients will be recruited (50 adults and 50 children). If the feasibility study is successful and we are awarded the funding for the full study it is hoped that those patients recruited to the pilot study will form the first group of patients in the main study.
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Ethics approval
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Not provided at time of registration
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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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Respiratory tract diseases: Asthma
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Participants - inclusion criteria
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N/A
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Participants - exclusion criteria
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Not provided at time of registration
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Anticipated start date
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30/11/1995
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Anticipated end date
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29/05/1998
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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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200 adults and 200 children
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Interventions
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We estimate that for the main trial it will be necessary to recruit 200 adults and 200 children which will require about 160 practices. Children (3-8 years) and adults will be randomised to receive either inhaled steroid (budesonide 100 µg and 200 µg bd.) or matched placebo and patients will be followed up at 6-monthly intervals for 4 years, with measurements of peak expiratory flow (over 2 weeks), symptoms, inhaled beta2-agonist use, exacerbations and a quality of life assessment.
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Primary outcome measure(s)
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To measure risks we will measure the growth in children and bone density in children and adults. A cost-effectiveness analysis will also be performed.
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Secondary outcome measure(s)
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Not provided at time of registration
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Sources of funding
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NIHR Health Technology Assessment Programme - HTA (UK)
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Trial website
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Publications
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Contact name
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Prof
Peter
Barnes
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Address
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University of London
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City/town
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London
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Zip/Postcode
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SW3 6LY
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Country
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United Kingdom
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Tel
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+44 (0)20 7351 8174
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Fax
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+44 (0)20 7351 5675
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Email
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p.j.barnes@ic.ac.uk
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Sponsor
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Department of Health (UK)
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Address
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Quarry House
Quarry Hill
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City/town
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Leeds
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Zip/Postcode
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LS2 7UE
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Country
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United Kingdom
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Email
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Sheila.Greener@doh.gsi.gov.uk
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Sponsor website:
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http://www.dh.gov.uk/en/index.htm
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Date applied
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25/04/2003
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Last edited
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10/01/2008
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Date ISRCTN assigned
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25/04/2003
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