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Pharmacokinetics of Inhaled Monodisperse Fluticasone Propionate

NCT00692978 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2020-11-25

Study results available
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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.

Conditions

Interventions

DRUG

Fluticasone Propionate_1.5

Dose 50 micrograms (total dose), Monodisperse aerosol with particle size of drug 1.5 micros, inhaled

DRUG

Fluticasone Propionate_3

Dose 50 micrograms (total dose), Monodisperse aerosol with particle size of drug 3.0 microns, inhaled

DRUG

Fluticasone Propionate_6

Dose 50 micrograms (total dose), Monodisperse aerosol with particle size of drug 6.0 microns, inhaled

DRUG

FP From Active 250 ug MDI Inhaler

Monodisperse aerosols inhaled of Fluticasone Propionate at 250micrograms dose with active MDI inhaler

Sponsors & Collaborators

  • Imperial College London

    lead OTHER

Principal Investigators

  • O S Usmani, MD, PhD · Imperial College London

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-08-31
Primary Completion
2011-07-03
Completion
2011-07-03

Countries

  • United Kingdom

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00692978 on ClinicalTrials.gov