PD study comparing Fluticasone dose/response through FENO inhibition

• Research type

  Research Study

• Full title

  A Pharmacodynamic Study of Fluticasone Propionate as a Dry Powder in Combination with Salmeterol in Patients with Asthma for Dose-Scale Comparison of a Test and Reference Product in a FENO Inhibition Model

• IRAS ID

  83543

• Sponsor organisation

  Oriel Therapeutics Inc, a Sandoz Company

• Eudract number

  2011-002420-40

• ISRCTN Number

  xx

• Research summary

  This study is being carried out on behalf of Oriel Therapeutics (the Sponsor, a pharmaceutical company based in the US) by Quintiles. Oriel Therapeutics is currently developing a new dry powder inhalation device OT329 Solis containing the drugfluicasone propionate and salmeterol xinafoate (referred to afluicasone and salmeterol throughout this document) for the maintenance treatment of asthma. Preparations containinfluicasone and salmeterol as inhaled medication are well established prophylactic therapy for the maintenance treatment of asthma. During this study volunteers will receive the product approved in the US (Advair© Diskus©) and new test product OT329 Solis.Advair© Diskus© is identical in all but name to the product approved in the UK (Seretide© Accuhaler©).Lung inflammation in subjects with asthma results in production of Nitric Oxide which can be measured in breath as Fractional Expired Nitric Oxide (FENO).The FENO measurement has widely been accepted as marker of lung inflammation.In this study the inhibition of FENO following 5 days treatment with once daily Advair Diskus (100/50, 250/50 or 500/50) will be compared to the inhibition of FENO following the OT329 Solis (100/50) test product. From this data it will be determined that in comparable doses the test product OT329 Solis provides equivalent effect on lung inflammation as the reference product Advair.This is a multi-centre study. It is anticipated that approximately 48 volunteers with asthma will be allocated to treatment to ensure 40 volunteers complete the study. Each volunteer will participate in 4 treatment periods, each period lasting 5 days. Each treatment will be separated by approximately 14 days.The total volume of blood to be taken will be no more than 15 ml per volunteer for the whole study.

• REC name

  London - Westminster Research Ethics Committee

• REC reference

  11/LO/1004

• Date of REC Opinion

  7 Sep 2011

• REC opinion

  Further Information Favourable Opinion