Delivering Tobramycin using the TobrAir device (QBR112053)

• Research type

  Research Study

• Full title

  Assessment of the Delivery of Tobramycin Using the TobrAir® 5.0 Device Compared with the Delivery of Marketed Tobramycin Nebuliser Solution (TOBI®) from the PARI LC® PLUS Using Pharmacoscintigraphic Methods

• IRAS ID

  111479

• Contact name

  Philip Evans

• Sponsor organisation

  PharmAero ApS

• Eudract number

  2012-003081-40

• ISRCTN Number

  xx

• Research summary

  The Sponsor is developing the study drug, Tobramycin, for the treatment of infection in cystic fibrosis patients. The study will aim to assess the delivery of Tobramycin, the study drug, to the lungs using the TobrAir© 5.0 device compared with marketed Tobramycin Nebuliser Solution (TOBI©) from the PARI LC© PLUS. The study will use pharmacoscintigraphic methods to assess lung deposition (how well the drug is deposited into the lungs), as well as the pharmacokinetic profile (PK) (how well the drug is absorbed into the bloodstream) of Tobramycin and its safety and tolerability. This study will dose Tobramycin to healthy male and female subjects over 2 study periods. In Regimen A, the subjects will be dosed with 75 mg of Tobramycin via the TobrAir 5.0 device. In Regimen B, the subjects will be dosed with 300 mg of Tobramycin via the PARI LC© PLUS device. The Tobramycin doses will be radiolabelled with 99m-Tc in both regimens, to allow scintigraphic analysis. Immediately before dosing, the subjects will receive a 5 mL nebulisation of 0.9% sodium chloride solution via a PARI LC© PLUS device, to prepare the throat before inhalation.

• REC name

  London - Brent Research Ethics Committee

• REC reference

  12/LO/1499

• Date of REC Opinion

  10 Oct 2012

• REC opinion

  Further Information Favourable Opinion