A Study to Assess Safety and Efficacy of a Novel Treatment, Keratinocyte Growth Factor (KGF), in Asthmatic Patients
Status:
Completed
Trial end date:
2011-07-01
Target enrollment:
Participant gender:
Summary
This study will look at the permeability, or 'leakiness' of the airway epithelium (the inner
lining of the lung) in asthmatic patients. Increased leakiness of this lining has been shown
in asthmatic patients by other studies, not only in the lung but also possibly in the gut,
perhaps reflecting a widespread defect. This leakiness may underline the interaction between
the environment and a person's genetic make up, and may contribute to why some people get
asthma, and how severe it is. Increased leakiness may allow increased exposure to inhaled
allergic substances, helping to perpetuate the inflammation in the lungs that is a hallmark
of asthma.
Specifically, this study will attempt to modify and reduce this permeability through the use
of a substance called 'keratinocyte growth factor', or 'kgf'. KGF is a naturally occuring
human protein, which is involved in stimulating the growth of cells lining the layers of the
skin and gut, helping to repair damage and maintain their structure. It has been manufactured
in a laboratory as the commercial compound 'Palifermin', which has already been used in
humans to reduce damage to the lining of the mouth after chemotherapy. The study will see if
Palifermin can similarly improve the lining of the lung in asthma patients and improve their
symptoms. To date no treatments have been used in this area in asthma, and if successful the
study will open up a whole new area of therapy
Phase:
Phase 2
Details
Lead Sponsor:
University Hospital Southampton NHS Foundation Trust