The Clinical Effect of Monodisperse Fluticasone Propionate in Asthma

• Research type

  Research Study

• Full title

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

• IRAS ID

  26533

• Contact name

  Omar S Usmani

• Sponsor organisation

  Imperial College London

• Eudract number

  2011-000706-21

• ISRCTN Number

  n/a

• Research summary

  CLINICAL EFFECT OF INHALED MONODISPERSfluICASONE PROPIONATEIt is the intention to treat 24 mild to moderate asthmatic subjects who will be invited to participate. The purpose of the study is to measure the clinical effect of inhaling monodisperse particles ofluicasone Propionate (which are a fine aerosol cloud mist of same sized drug particles) of two different sizes (1.5 and 6 microns). The monodisperse aerosol will be generated by the Spinning Top Aerosol Generator (STAG) (a large research nebuliser machine). These aerosols will be delivered at a dose of 50 micrograms. We will also deliver FP at a dose of 250 micrograms, which is a commonly used dose in the clinic for patients with asthma, from a Metered Dose Inhaler (MDI) with a spacer (which delivers a coarse aerosol cloud mist of different sized drug particles). On each study day Adenosine Monophosphate (AMP), which measures airway twitchiness, will be given 2 hours following the delivery of FP. The concentration necessary to produce a fall in the simple blowing test, FEV1 (Forced Expiratory Volume in 1 Second), of 20% (PC20) will be measured. We will also be measuring the maximum amount ofluicasone Propionate (FP) in the blood stream following inhalation of FP and placebo. Participants will attend a screening visit at the Asthma Laboratory, Royal Brompton Hospital (RBH) and undergo a medical history, questionnaire and medical examination. They will also undergo spirometry tests (simple breathing tests), a skin prick allergy test and a Multiple-breath washout (MBW) test (another breathing test). A review of the inclusion and exclusion criteria will take place and written informed consent will be obtained.

• REC name

  London - Harrow Research Ethics Committee

• REC reference

  11/LO/0262

• Date of REC Opinion

  12 Jul 2011

• REC opinion

  Further Information Favourable Opinion