Pharmacokinetics of Inhaled Monodisperse Fluticasone Propionate
Status:
Completed
Trial end date:
2011-07-03
Target enrollment:
Participant gender:
Summary
Asthma is most effectively treated by delivering inhaled drugs from an inhaler (puffer)
directly into the lungs. Inhaled steroids are used in asthmatic patients to dampen down lung
inflammation, which unchecked, can often lead to patient symptoms. Inhalers deliver a mist
containing particles of lots of different sizes (like hairsprays). Medical puffers used by
patients produce a 'coarse' mist of drug particles, which have the potential for side
effects, as different sized particles will reach different parts of the airways and include;
the mouth, the throat, the windpipe, and the bloodstream (all places we do not want the
inhaled drug to go - and can give rise to important side effects)and, the lungs (where we do
want the drug to 'deposit').
Our aim in this study is to test an inhaled steroid by giving it to subjects as a 'fine' mist
containing drug particles of nearly all one size using a research nebuliser (a Spinning Top
Aerosol Generator). We shall use small, intermediate and large drug particle mists. We aim to
find out how much of the drug goes to the blood stream for each particle mist and compare it
with the standard puffers used in routine clinical practice.
We hope this study will provide information to the rationale that by improving the efficiency
of drug delivery (by changing drug particle size) one may improve inhaled drug delivery and
ultimately, clinical patient benefit.
Healthy volunteers and asthmatic patients will be recruited at the Royal Brompton Hospital
London. The study is funded by GlaxoSmithKline, Research & Development, U.K.