PK, Safety Study for Combined Asthma Inhalers 500/50 mcg (Charcoal)

• Research type

  Research Study

• Full title

  An Open-Label, Single-Dose, Randomized, Four-Way Crossover, Pilot Study to Compare the Pharmacokinetic and Safety Profiles Following Two Inhalations of Fluticasone Propionate/Salmeterol Spiromax® 500/50 mcg Inhalation Powder and Seretide® Accuhaler® 500/50 mcg, With and Without Charcoal Block, Administered in Healthy Volunteers

• IRAS ID

  36606

• Contact name

  Stephen P Smith

• Sponsor organisation

  Teva Global Respiratory Research LLC

• Eudract number

  2009-015411-40

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  Seretide© Accuhaler© is a combination ofluicasone propionate and Salmeterol (FS) inhalation powder delivered via a dry powder inhaler. It was approved in the UK in 1999 for the long-term, twice daily, maintenance treatment of asthma (it is also marketed in the US as Advair Diskus©). The study Sponsor has developed a combination ofluicasone propionate and Salmeterol in a new dry powder inhaler (FS DPI 500/50 mcg) that is comparable to Seretide© Accuhaler©. This is held in a new breath-operated delivery device. The purpose of this study is to compare the amount of and rate at which FS from the new DPI gets into the bloodstream (the ??pharmacokinetic profile?) with Seretide© Accuhaler© when each is given as two inhalations. In order to look specifically at the amount of each product that gets into the bloodstream specifically through the lungs and not the digestive system, a charcoal suspension will be given with each product during the study. The same products will also be given without the charcoal for a comparison. Volunteers will receive the following products in a random order on four separate occasions during the course of the study: * 2 x inhalations of FS DPI 500/50 mcg * 2 x inhalations of Seretide© Accuhaler© 500/50 mcg * 2 x inhalations of FS DPI 500/50 mcg with charcoal block * 2 x inhalations of Seretide© Accuhaler© 500/50 mcg with charcoal block Therefore, each of the two study products will be given alone on two separate occasions (a single dose each time given as 2 inhalations, for a total dose on each occasion of 1000 mcg ofluicasone propionate and 100 mcg of Salmeterol), and again on two separate occasions with charcoal block, for a total of 4 occasions. On each of the 2 occasions the charcoal block is given, it will be given over approximately a 4 hour period in 5 small (5 gram) doses. The safety of the two study products, given with and without charcoal block, will also be assessed. A total of 20 male and female volunteers (aged 18-45 years) will take part in this study. Asthmatics cannot participate in the study.

• REC name

  South Central - Berkshire B Research Ethics Committee

• REC reference

  09/IEC04/4

• Date of REC Opinion

  16 Mar 2010

• REC opinion

  Further Information Favourable Opinion