50 mg of monodisperse Fluticasone Propionate delivered as 1.5 microns aerosol followed by AMP PC20 challenge test

50 mg of monodisperse Fluticasone Propionate delivered as 6.0 microns aerosol followed by AMP PC20 challenge test

No active drug, just solvent delivered from STAG followed by AMP PC20 challenge test

Fluticasone Propionate , Metered dose inhaler, 250 mg dose followed by AMP PC20 challenge test

All Participants

Sex: Female, Male

Region of Enrollment

Dose Provoking Fall in FEV1 of 20% at baseline

Dose Provoking Fall in FEV1 of 20%

The concentration of Adenosine Monophosphate (AMP), measured in mg/ml, required to see a 20% fall in the patient's forced expiratory volume in 1 second (FEV1) is measured after taking FP aerosol. AMP is a bronchoconstrictor agent (ie it narrows the airways. We would expect that more would be necessary to produce the same 20% fall in FEV1 after receiving the FP than before due to the reduction in airways inflammation. This change is the primary outcome measure.

50 mg of monodisperse Fluticasone Propionate delivered as 1.5 microns aerosol followed by AMP PC20 challenge test
AMP CHALLENGE PC20: Dose Provoking Fall in FEV1 of 20% (mg/ml)

Monodisperse FP 1.5um

50 mg of monodisperse Fluticasone Propionate delivered as 6.0 microns aerosol followed by AMP PC20 challenge test
AMP CHALLENGE PC20: Dose Provoking Fall in FEV1 of 20% (mg/ml)

Monodisperse FP 6.0um

No active drug, just solvent delivered from STAG followed by AMP PC20 challenge test
AMP CHALLENGE PC20: Dose Provoking Fall in FEV1 of 20% (mg/ml)

Placebo STAG

Fluticasone Propionate , Metered dose inhaler, 250 mg dose followed by AMP PC20 challenge test
AMP CHALLENGE PC20: Dose Provoking Fall in FEV1 of 20% (mg/ml)

MDI FP

AMP Challenge Test PC20

The concentration of Fluticasone Propionate in blood following inhalation of the dose will be measured. Cmax will be measured.

50 micrograms of monodisperse Fluticasone Propionate delivered as 6.0 micrometers
Fluticasone Propionate 50 micrograms: Drug: Fluticasone Propionate Dose 50 micrograms (total dose), Monodisperse aerosol with two differemt particle size of drug (1.5, 6.0 microns) generated by Spinning Top Aerosol Generator (STAG)

Monodisperse Fluticasone Propionate 6.0 Microns

50 micrograms of monodisperse Fluticasone Propionate delivered as 1.5 micrometers
Fluticasone Propionate 50 micrograms: Drug: Fluticasone Propionate Dose 50 micrograms (total dose), Monodisperse aerosol with two differemt particle size of drug (1.5, 6.0 microns) generated by Spinning Top Aerosol Generator (STAG)

Monodisperse Fluticasone Propionate 1.5microns

No active drug, just solvent delivered from STAG
Placebo monodisperse aerosol dose: Solvent only delivered, no drug

Fluticasone Propionate Inhaled, Metered dose inhaler, 250 micrograms dose (total dose)
Inhaled, Metered dose inhaler, 250 micrograms dose (total dose): Inhaled, Metered dose inhaler, 250 micrograms dose (total dose), delivered via spacer

Metered Dose Inhaler of Fluticasone Propionate

The Concentration of Fluticasone Propionate

FEV1 and FVC will be measured before and after drug administration

Spirometry

At each study visit subjects will breathe in oxygen from a machine, which at the same time will measure the composition of the gases in each exhaled breath. The main gas we are interested in is nitrogen as this makes up the bulk of the air that we breathe. This test is known as the 'multi-breath nitrogen washout'. The test takes 20 minutes and we shall do this at the beginning and at the end of each study visit.

Multi-breath Nitrogen Washout Test

First 50 micrograms of Monodisperse Fluticasone Propionate delivered as 6.0 microns, then 50 micrograms of Monodisperse Fluticasone Propionate 1.5microns, next is Placebo STAG, and Metered dose inhaler of Fluticasone Propionate last

First Monodisperse Fluticasone Propionate 6.0 Microns

First 50 micrograms of Monodisperse Fluticasone Propionate delivered as 1.5 microns, then 50 micrograms of Monodisperse Fluticasone Propionate 6.0 microns, next is Placebo STAG, and Metered dose inhaler of Fluticasone Propionate last

First Monodisperse Fluticasone Propionate 1.5microns

First Placebo STAG, then 50 micrograms of Monodisperse Fluticasone Propionate delivered as 1.5 microns, then 50 micrograms of Monodisperse Fluticasone Propionate 6.0 microns, and Metered dose inhaler of Fluticasone Propionate last

First Placebo STAG

First Metered dose inhaler of Fluticasone Propionate, then Placebo STAG, then 50 micrograms of Monodisperse Fluticasone Propionate delivered as 1.5 microns, and 50 micrograms of Monodisperse Fluticasone Propionate 6.0 microns last

First Metered Dose Inhaler of Fluticasone Propionate

Period 1

Period 2

Period 3

Period 4

Dr Omar Usmani

50 mg of monodisperse Fluticasone Propionate delivered as 1.5 microns aerosol followed by AMP PC20 challenge test
1.5 microns at 50mg: STAG generated monodisperse 1.5micron particles

50 mg of monodisperse Fluticasone Propionate delivered as 6.0 microns aerosol followed by AMP PC20 challenge test
6 microns at 50mg: STAG generated monodisperse 6 micron particles

No active drug, just solvent delivered from STAG followed by AMP PC20 challenge test
Placebo Comparator: No drug just solvent

Fluticasone Propionate , Metered dose inhaler, 250 mg dose followed by AMP PC20 challenge test
MDI FP

Asthma

STAG generated monodisperse 1.5micron particles

1.5 microns at 50mg

STAG generated monodisperse 6 micron particles

6 microns at 50mg

Placebo Comparator

Asthma Lab, Royal Brompton Hospital

Department of Nuclear Medicine, Royal Brompton Hospital

The Clinical Effect of Monodisperse Fluticasone Propionate in Asthma

The Clinical Effect in Asthma of Inhaled Fluticasone Propionate Delivered as Monodisperse Aerosols

Imperial College London

GlaxoSmithKline

Monodisperse aerosols inhaled of Fluticasone Propionate 1.5microns size at 50micrograms dose with double-dummy placebo MDI inhaler

Monodisperse aerosols inhaled of Fluticasone Propionate 3.0microns size at 50micrograms dose with double-dummy placebo MDI inhaler

Monodisperse aerosols inhaled of Fluticasone Propionate 6 microns size at 50micrograms dose with double-dummy placebo MDI inhaler

etered dose inhaler of Fluticasone Propionate 250 micrograms dose, inhaled, with double-dummy placebo monodisperse aerosol

Healthy

Dose 50 micrograms (total dose), Monodisperse aerosol with diofferemt particle size of drug (1.5, 3.0, 6.0 microns), inhaled

Fluticasone Propionate

Inhaled, Metered dose inhaler, 250 micrograms dose (total dose)

leucadendron laureolum/bronxial astma

The Clinical Effect of Monodisperse Fluticasone Propionate in Asthma

Pharmacokinetics of Inhaled Monodisperse Fluticasone Propionate

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