A study of asthma medication/inhaler combinations

• Research type

  Research Study

• Full title

  A Phase I Pilot Pharmacokinetic Study in Healthy Subjects of Fluticasone Propionate/Salmeterol Xinafoate Combinations Administered as Dry Powders in Solis™ versus Diskus®

• IRAS ID

  82593

• Sponsor organisation

  Oriel Therapeutics Inc.

• Eudract number

  2011-002418-35

• ISRCTN Number

  xx

• Research summary

  Oriel Therapeutics, Inc. is developing a new dry powder oral inhalation device containing the drugfluicasone propionate and salmeterol xinafoate (hereafter, referred to afluicasone and salmeterol) for the maintenance treatment of asthma. The Oriel inhalation device is named Solis?½. Preparations containinfluicasone and salmeterol as inhaled medication are well established prophylactic therapy for the maintenance treatment of asthma. The purpose of this study is to compare the pharmacokinetics (blood levels) ofluicasone and salmeterol following administration from Solis with a those following dosing of fluicasone/salmeterol reference product already approved for commercial use (Advair Diskus© in the US, Seretide Accuhaler© in the UK). One strength of the product will be investigated: 100mcfluicasone/50mcg salmeterol. This product strength is commercially available. The observation of blood levels allows Oriel Therapeutics, Inc. to determine whether the dose delivered to the lungs is comparable to that delivered by the commercially available reference product.In this trial (Study OTT329/204) up to 24 healthy adult male and female volunteers will be treated with combinations ofluicasone/salmeterol administered as a single dose by dry powder oral inhalation. The dose will be administered following an overnight (minimum 10 hours) fast which will continue until 4 hours post-dose (water allowed ad lib except for 1 hour prior through 1 hour post dose). Blood samples for determination of thfluicasone and salmeterol concentrations in the blood will be collected at serial timepoints from each subject prior to dose administration and continuing until 72 hours post dose.

• REC name

  London - Westminster Research Ethics Committee

• REC reference

  11/LO/0921

• Date of REC Opinion

  29 Jul 2011

• REC opinion

  Further Information Favourable Opinion