Lung deposition of Flutiform® pMDI 250/10 µg (500/20 µg) (QBR110634)

• Research type

  Research Study

• Full title

  An open-label, single dose study to assess the lung deposition of Flutiform® pMDI 250/10 µg (500/20 µg total dose) in healthy and asthmatic subjects.

• IRAS ID

  111910

• Contact name

  Sharan Sidhu

• Sponsor organisation

  Mundipharma Research Limited

• Eudract number

  2011-001907-11

• Research summary

  The Sponsor has developed the study drugfluiform©, for the treatment of asthmafluiform© is a combination product of the active ingredientfluicasone (inhaled corticosteroid) and formoterol (long-acting Ç?-agonist). The Sponsor has developed three strengths ofluiform©: 50/5 æg, 125/5 æg and 250/10 æg. This study will dose the higher strength of 250/10 æg to healthy subjects and asthma patients, administered as two puffs via a pressurised metered dose inhaler (pMDI), giving a total dose of 500/20 æg. Male and female subjects aged 18-65 years will be recruited with an aim to enrol 26 subjects to achieve 10 completing subjects in healthy/asthmatic groups. The duration for a subject is up to 35 days. The study will generate scinitgraphic imaging data to assess the lung deposition of the study drug.

• REC name

  HSC REC A

• REC reference

  12/NI/0133

• Date of REC Opinion

  13 Sep 2012

• REC opinion

  Further Information Favourable Opinion