Clinical trial NCT00692978
Conditions: Healthy Asthma
Keywords: Monodisperse aerosols Healthy Volunteers Asthmatics Pharmacokinetics Randomized
Sponsor: Imperial College London
Start date: 2008-08-01; Completion date: 2011-07-03
Enrollment: 30 participants; Allocation: RANDOMIZED; Intervention model: FACTORIAL

Brief 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.

Detailed description:
The clinical trial is to investigate the pharmacokinetic effects (that is how much drug is in the blood) of Fluticasone Propionate (Flixotide), a commonly used steroid drug that is inhaled in patients with asthma. We will use standard clinical Flixotide Nebules that are used with clinical nebulisers (machines used in hospital and at home - to deliver drug to patients with asthma). Current clinical nebulisers deliver a 'coarse' mist of drug, which has the potential for side effects and this is an important consideration with steroids. These Flixotide nebules will be used to deliver the drug (fluticasone propionate) as monodisperse aerosol clouds (that is the drug will be delivered as a 'fine' mist cloud to patients). In order to deliver the drug as a monodisperse aerosol, the Flixotide Nebules will be used with a spinning top aerosol (a large research nebuliser machine)which is able to selectively generate aerosol clouds that have a fine mist. A fine mist cloud leads to less deposition in the throat of the patients and a greater control of the inhaled drug reaching the lungs, and fine mist drug clouds have the potential to reduce side effects. We will also compare this to the use of a standard routine clinical dose of a Flixotide metered-dose inhaler ( a 'press and breathe' inhaler) with a spacer (plastic bubble on the end of an inhaler) delivered to patients.

Arms: arm 1: Asthma patients arm 2: Healthy participants
Interventions: intervention 1: Fluticasone Propionate_1.5 intervention 2: Fluticasone Propionate_3 intervention 3: Fluticasone Propionate_6 intervention 4: FP From Active 250 ug MDI Inhaler
Intervention descriptions: intervention 1: Dose 50 micrograms (total dose), Monodisperse aerosol with particle size of drug 1.5 micros, inhaled intervention 2: Dose 50 micrograms (total dose), Monodisperse aerosol with particle size of drug 3.0 microns, inhaled intervention 3: Dose 50 micrograms (total dose), Monodisperse aerosol with particle size of drug 6.0 microns, inhaled intervention 4: Monodisperse aerosols inhaled of Fluticasone Propionate at 250micrograms dose with active MDI inhaler

Protocol documents: