A Study to Investigate Lung Deposition of Radiolabelled OligoG
Status:
Completed
Trial end date:
2014-09-01
Target enrollment:
Participant gender:
Summary
OligoG is a new potential treatment which is being developed by AlgiPharma AS (a
Norwegian-based company) with an aim to help people with cystic fibrosis in the future.
OligoG, derived from marine algae, is expected to act locally in the lungs once inhaled to
reduce mucus thickness and improve mucus clearance. It could also have the benefit of
reducing the incidence of infections.
Nebulised doses of up to 540 mg/day have been administered to healthy volunteers for three
consecutive days and to cystic fibrosis patients for 28 consecutive days. Both groups
tolerated the medication well, with no treatment related issues reported. The dose
administered in this study is lower; patients who complete the study will receive, in total,
186 mg of OligoG in two divided doses.
A new dry powder formulation of OligoG has been developed so that patients can use an
inhaler, rather than a nebuliser. Administration from an inhaler compared to a nebuliser is
much quicker and more practical for the patient.
In this study, we will use gamma scintigraphy to see where in the lungs the dry powder and
nebulised solution go after being inhaled by cystic fibrosis patients. Gamma scintigraphy is
a well-established medical imaging technique. A small amount of radioactive material will be
added to both the dry powder and nebulised solution. The radiation emitted will then be
detected by taking images using a device known as a gamma camera. The procedure is relatively
easy and non-invasive.
The purpose of this study is to help answer the following research questions:
- How do the OligoG dry powder and nebulised solution distribute in the lungs of patients
with cystic fibrosis?
- How much of the formulation gets to the deep lung?
- How much of the formulation remains in the devices used for administration?