QBR106639

• Research type

  Research Study

• Full title

  Assessment of the delivery of tobramycin using the Tobrair® 4.0 device compared with delivery of marketed tobramycin nebuliser solution (TOBI®) from the PARI LC® PLUS using pharmacoscintigraphic methods

• IRAS ID

  64006

• Contact name

  Philip Evans

• Sponsor organisation

  PharmAero

• Eudract number

  2010-022735-11

• Research summary

  The purpose of the study is to look at how tobramycin is taken up by the lungs using two different devices, the new Tobrair© 4.0 device and the PARI LC© PLUS jet nebuliser. The drug tobramycin is already marketed for the treatment of long term infection due to specific bacteria in patients with cystic fibrosis since 2006. It is commonly given using the PARI LC© PLUS jet nebuliser in clinical practice. Due to the time taken to deliver the drug to patients using currently available nebulisers there is a need for the continued development of new technologies to reduce treatment time and thereby improve compliance. This version of the Tobrair© 4.0 device has never been used in man before. A similar version of the device has been used with the liquid form of the drug to be used in the device. The effectiveness of this device to deliver radiolabelled tobramycin to the lungs will be compared with the PARI LC© PLUS jet nebuliser using a gamma camera and by monitoring blood levels of the drug. Radiolabelled means that the drug is associated with a small amount of radioactivity.

• REC name

  North West - Greater Manchester Central Research Ethics Committee

• REC reference

  10/IEC01/22

• Date of REC Opinion

  26 Oct 2010

• REC opinion

  Further Information Favourable Opinion