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ISRCTN
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ISRCTN98813895
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ClinicalTrials.gov identifier
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Public title
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Investigation of the protective effects of keratinocyte growth factor (KGF) in a human lipopolysaccharide induced model of acute lung injury
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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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MRC ref: G0701690; 08005DM-A
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Study hypothesis
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Does treatment with a clinically relevant dose of keratinocyte growth factor (KGF) reduce pulmonary and systemic inflammation induced by lipopolysaccharide (LPS) inhalation in humans?
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Lay summary
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http://www.nres.npsa.nhs.uk/researchsummaries/?entryid29=20564&q=0%c2%ac08%2fNIR02%2f46%c2%ac
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Ethics approval
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Health and Social Care (HSC) Research Ethics Committee (REC2), Department of Health, Social Services and Public Safety (DHSSPS), approved on 21/07/2008 (ref: 08/NIR02/46)
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Study design
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Prospective randomised double-blind placebo-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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Acute lung injury (ALI)
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Participants - inclusion criteria
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Healthy subjects, both males and females
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Participants - exclusion criteria
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1. Age <18 years
2. Pregnancy, breast-feeding or women of childbearing potential not using adequate contraception
3. Serum amylase above upper limit of normal
4. Consent declined
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Anticipated start date
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01/08/2008
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Anticipated end date
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01/08/2011
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Status of trial
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Completed |
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Patient information material
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Not available in web format, please use the contact details below to request a patient information sheet
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Target number of participants
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36
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Interventions
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Subjects will be randomised to palifermin 60 µg/kg per day or normal saline placebo intravenously for 3 days prior to LPS inhalation.
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Primary outcome measure(s)
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The ability of KGF to reduce alveolar inflammation, as measured by the difference in bronchoalveolar lavage (BAL) receptor for advanced glycation end products (RAGE) concentration between the KGF and placebo treated groups at 6 hours post LPS inhalation.
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Secondary outcome measure(s)
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1. Alveolar inflammatory response at 6 hours post LPS inhalation
2. Plasma inflammatory response (C-reactive protein) at 24 hours post LPS inhalation
3. Alveolar matrix metalloproteinase activity at 6 hours post LPS inhalation
4. Intracellular signalling in the alveolar space at 6 hours post LPS inhalation
5. Indices of alveolar epithelial and endothelial function and injury at 6 hours post LPS inhalation
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Sources of funding
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1. Medical Research Council (UK) (ref: G0701690)
2. REVIVE (a charity which supports research in the intensive care unit in the Royal Victoria Hospital, Belfast) (UK)
3. Northern Ireland Chest Heart and Stroke (NICHS) (UK)
Added as of 30/12/2008:
4. Research and Development Office, Northern Ireland Health and Social Services, Central Services Agency (UK)
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Trial website
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Publications
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Contact name
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Dr
Danny
McAuley
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Address
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Intensive Care Unit
Royal Victoria Hospital
Grosvenor Road
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City/town
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Belfast
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Zip/Postcode
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BT12 6BA
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Country
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United Kingdom
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Sponsor
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Belfast Health and Social Care Trust (UK)
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Address
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51 Lisburn Road
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City/town
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Belfast
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Zip/Postcode
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BT9 7AB
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Country
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United Kingdom
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Tel
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+44 289 03 29241
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Email
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rosemary.mcveigh@belfasttrust.hscni.net
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Sponsor website:
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http://www.belfasttrust.hscni.net
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Date applied
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25/04/2008
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Last edited
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05/07/2011
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Date ISRCTN assigned
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12/12/2008
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