Systemic exposure of FlutiForm® pMDI with and without spacer.

• Research type

  Research Study

• Full title

  An open-label, single dose, randomised, 2-part crossover study to assess the systemic exposure of high dose FlutiForm® pMDI 250/10 µg (500/20 µg total dose) with and without spacer (AeroChamber Plus) in healthy subjects.

• IRAS ID

  66845

• Contact name

  Thomas Jerome Hanna

• Sponsor organisation

  Mundipharma Research Limited

• Eudract number

  2010-023232-17

• Research summary

  This study is designed to determine the total amount of study drug in the bloodstream after administration via two different methods using a metered dose inhaler with and without a spacer.

• REC name

  HSC REC B

• REC reference

  10/NIR03/57

• Date of REC Opinion

  6 Dec 2010

• REC opinion

  Further Information Favourable Opinion