A Pilot PD/PK Study of Fluticasone Propionate

• Research type

  Research Study

• Full title

  A Pilot Pharmacodynamic/Pharmacokinetic Study of Fluticasone Propionate Administered as a Dry Powder in Patients with Asthma

• IRAS ID

  38894

• Contact name

  Darren Wilbraham

• Sponsor organisation

  Oriel Therapeutics Inc

• Eudract number

  2009-017099-25

• ISRCTN Number

  xx

• Research summary

  A specific assessment of lung function called Fractional Expired Nitric Oxide (FENO) has been widely accepted as a non-invasive marker of lung inflammation. The purpose of this pilot study is to determine if FENO can provide adequate information with in a few days of treatment with inhalefluicasone (a licensed medication for asthma). This would allow FENO to be used earlier in the development process of new inhaled products.The study will take place at Quintiles Limited, Guy's Drug Research Unit. Up to 30 mild asthmatic volunteers will participate in the trial. Each volunteer will attend the unit for three admission periods each lasting 6 days, during which timethey will receivfluicasone daily.

• REC name

  London - Westminster Research Ethics Committee

• REC reference

  09/H0802/114

• Date of REC Opinion

  4 Jan 2010

• REC opinion

  Further Information Favourable Opinion