Plain English Summary
http://www.nres.npsa.nhs.uk/researchsummaries/?entryid29=20564&q=0%c2%ac08%2fNIR02%2f46%c2%ac
Trial website
Additional identifiers
EudraCT number
2008-000441-58
ClinicalTrials.gov number
Protocol/serial number
MRC ref: G0701690; 08005DM-A
Study information
Scientific title
Acronym
Study hypothesis
Does treatment with a clinically relevant dose of keratinocyte growth factor (KGF) reduce pulmonary and systemic inflammation induced by lipopolysaccharide (LPS) inhalation in humans?
Ethics approval
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)
Study design
Prospective randomised double-blind placebo-controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Acute lung injury (ALI)
Intervention
Subjects will be randomised to palifermin 60 µg/kg per day or normal saline placebo intravenously for 3 days prior to LPS inhalation.
Intervention type
Drug
Phase
Not Specified
Drug names
Keratinocyte growth factor (KGF)
Primary outcome measures
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.
Secondary outcome measures
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
Overall trial start date
01/08/2008
Overall trial end date
01/08/2011
Reason abandoned
Eligibility
Participant inclusion criteria
Healthy subjects, both males and females
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
36
Participant exclusion criteria
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
Recruitment start date
01/08/2008
Recruitment end date
01/08/2011
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Intensive Care Unit
Belfast
BT12 6BA
United Kingdom
Sponsor information
Organisation
Belfast Health and Social Care Trust (UK)
Sponsor details
51 Lisburn Road
Belfast
BT9 7AB
United Kingdom
+44 289 03 29241
rosemary.mcveigh@belfasttrust.hscni.net
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Medical Research Council (UK) (ref: G0701690)
Alternative name(s)
MRC
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
United Kingdom
Funder name
REVIVE (a charity which supports research in the intensive care unit in the Royal Victoria Hospital, Belfast) (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Northern Ireland Chest Heart and Stroke (NICHS) (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Added as of 30/12/2008:
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Research and Development Office, Northern Ireland Health and Social Services, Central Services Agency (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
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24716610
Publication citations
-
Results
Shyamsundar M, McAuley DF, Ingram RJ, Gibson DS, O'Kane D, McKeown ST, Edwards A, Taggart C, Elborn JS, Calfee CS, Matthay MA, O'Kane CM, Keratinocyte growth factor promotes epithelial survival and resolution in a human model of lung injury., Am. J. Respir. Crit. Care Med., 2014, 189, 12, 1520-1529, doi: 10.1164/rccm.201310-1892OC.