PK, Safety Study for Combination Asthma Inhalers 500/50 mcg

• Research type

  Research Study

• Full title

  An Open-Label, Single-Dose, Randomized, Two-Way Crossover, Pilot Study To Compare The Pharmacokinetic and Safety Profiles Following Two Inhalations of Fluticasone Propionate/Salmeterol Spiromax® 500/50 mcg Inhalation Powder vs Two Inhalations from Seretide® Accuhaler® 500/50 mcg in Healthy Volunteers Celerion Code: AA88457 Protocol Number: FSS-AS-104

• IRAS ID

  36121

• Contact name

  Stephen P Smith

• Sponsor organisation

  Teva Global Respiratory Research LLC

• Eudract number

  2009-015412-18

• 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's comparable to Seretide© Accuhaler©. This is held in a new breath-operated delivery device. The purpose of this study is to compare two batches of FS DPI with Seretide© Accuhaler©. The FS DPI batches differ in terms of the particle size of the powder. Volunteers will receive the following products in a random order on three separate occasions during the course of the study:?½ 2 x inhalations of FS DPI 500/50 mcg (Batch A)?½ 2 x inhalations of FS DPI 500/50 mcg (Batch B)?½ 2 x inhalations of Seretide© Accuhaler© 500/50 mcgThe total dose given for each product will be 1000 mcg ofluicasone propionate and 100 mcg of Salmeterol. The safety of the three products will also be assessed.A total of 18 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/IEC04/3

• Date of REC Opinion

  9 Dec 2009

• REC opinion

  Favourable Opinion