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ISRCTN
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ISRCTN99132811
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ClinicalTrials.gov identifier
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Public title
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A pragmatic single-blind randomised controlled trial and health economic evaluation of leukotriene receptor antagonists in primary care at steps two and three of the national asthma guidelines
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Scientific title
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Acronym
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ELEVATE
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Serial number at source
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HTA 98/34/05
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Study hypothesis
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This study will evaluate the relative clinical effectiveness and costs at time points over a two year follow-up (short-term specifically at two months and long-term over two years) of Leukotriene Receptor Antagonist (LTRA) prescription in primary care.
PRIMARY: To compare quality of life with LTRAs against alternative treatments at steps two and three of the guidelines, comparing resource use over a two year period to the NHS and patients (on an intention to treat basis), using either a cost-minimisation or cost-effectiveness approach. The choice will depend on whether differences emerge between the groups over two years with particular emphasis on two months and two years (i.e. short and long-term).
SECONDARY: To compare other clinically relevant asthma outcomes between two treatment groups at two months and throughout the two year study (see Primary outcomes).
The design enables this to be compared at step two with inhaled steroid prescription and at step three with add-on of a long-acting beta agonist prescription. Its pragmatic design coupled with clinical trial rigour:
1. Concealed randomised allocation of patients,
2. Blinded procedures for recording and collection of outcomes data (by a non-clinician) and blinded data analysis should produce results that are both valid and applicable to primary care as a whole.
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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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Asthma
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Participants - inclusion criteria
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Not provided at time of registration.
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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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01/10/2001
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Anticipated end date
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28/02/2007
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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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720
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Interventions
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Please note that, as of 25 January 2008, the start and end dates of this trial were updated from 1 January 2000 and 30 April 2003 to 1 October 2001 and 28 February 2007, respectively.
Interventions:
LTRAs versus alternative treatment
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Primary outcome measure(s)
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1. Need for further treatment intervention
2. Frequency of exacerbations
3. Short-acting beta agonist use
4. Hospitalisations
5. Time off work
6. Daily inhaled steroid dose (step three)
7. Asthma symptoms
8. Morning and diurnal variation in peak flow
9. Those with eczema/rhinitis comparative change in disease assessment
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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
David
Price
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Address
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Department of General Practice & Primary Care
University of Aberdeen
Foresterhill Health Centre
Westburn Road
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City/town
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Aberdeen
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Zip/Postcode
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AB25 2AY
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Country
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United Kingdom
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Tel
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+44 (0)1224 554588
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Fax
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+44 (0)1224 550683
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Email
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david@respiratoryresearch.org
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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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25/01/2008
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Date ISRCTN assigned
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25/04/2003
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