QBR110310 (060-102)

• Research type

  Research Study

• Full title

  A Phase 1, Open-Label, Two-Period, Randomized, Cross Over Scintigraphy Study Assessing Nasal Deposition of a Single Dose of a Ciclesonide Radiolabeled Solution following Nasal Inhalation of a Novel Nasal Metered dose Inhaler (Mdi) and of a Mometasone Furoate Monohydrate Radiolabeled Suspension Via an Aqueous (Aq) Nasal Spray

• IRAS ID

  76727

• Sponsor organisation

  Sunovion Pharmaceuticals Inc.

• Eudract number

  2011-000702-22

• Research summary

  Ciclesonide is a drug being developed by the sponsor company (Sunovion), as a nasal spray to treat allergic rhinitis (hayfever). Ciclesonide is already licensed for use in adults and adolescents over the age of 12 as an inhaled steroid (glucocorticosteroid) for the treatment of asthma. The purpose of the study is to look at where Ciclesonide is deposited within the nose and throat when delivered as a new nasal spray and how much may drip out of the nose. The study will also look at how an aqueous nasal spray spreads through the nose. The aqueous nasal spray is used for treating allergic rhinitis and also contains a steroid (Mometasone furoate monohydrate).

• REC name

  London - London Bridge Research Ethics Committee

• REC reference

  11/LO/0487

• Date of REC Opinion

  24 May 2011

• REC opinion

  Further Information Favourable Opinion