Condition category
Respiratory
Date applied
25/04/2008
Date assigned
12/12/2008
Last edited
19/05/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Contact information

Type

Scientific

Primary contact

Dr Danny McAuley

ORCID ID

Contact details

Intensive Care Unit
Royal Victoria Hospital
Grosvenor Road
Belfast
BT12 6BA
United Kingdom

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

http://www.belfasttrust.hscni.net

Funders

Funder type

Government

Funder name

Medical Research Council (UK) (ref: G0701690)

Alternative name(s)

MRC

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

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

  1. 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.

Additional files

Editorial Notes