Acute lung injury
Conditions
Interventions
Trade Name: Kepivance
Product Name: Palifermin
Pharmaceutical Form: Intravenous infusion
Pharmaceutical form of the placebo: Intravenous infusion
Route of administration of the placebo: Intravenous us
Sponsors
Belfast City Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Healthy non-smoking subjects Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Age < 18 years • Pregnancy • Breast-feeding • Women of childbearing potential not using adequate contraception • Serum amylase above upper limit of normal • Consent declined
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The hypothesis of the study is that treatment with a clinically relevant dose of KGF reduces pulmonary and systemic inflammation induced by LPS inhalation in humans. The primary endpoint of this study is to evaluate the ability of KGF to reduce alveolar epithelial injury, as measured by BAL RAGE concentration, between the KGF and placebo treated groups.;Secondary Objective: The secondary aims are to investigate if treatment with KGF will modulate: 1) alveolar inflammatory response 2) plasma inflammatory response 3) alveolar matrix metalloproteinase activity 4) intracellular signalling in the alveolar space 5) indices of alveolar epithelial and endothelial function and injury to determine the potential mechanisms by which KGF may be beneficial in ALI. ;Primary end point(s): The primary endpoint of this study is to evaluate the ability of KGF to reduce alveolar epithelial injury, as measured by BAL RAGE concentration, between the KGF and placebo treated groups. | — |
Countries
United Kingdom
Outcome results
None listed