Effects of CHF1535 NEXThaler DPI in asthma with and without charcoal

• Research type

  Research Study

• Full title

  A PHASE II, MONOCENTRE, OPEN, RANDOMIZED, 6-WAY CROSS-OVER CLINICAL PHARMACOLOGY STUDY TO EVALUATE THE LUNG BIOAVAILABILITY OF BDP/B17MP AND FORMOTEROL AND THE TOTAL SYSTEMIC EXPOSURE ACROSS TWO DIFFERENT DOSE STRENGTHS OF CHF 1535 NEXThaler® DPI (FIXED COMBINATION OF BECLOMETHASONE DIPROPIONATE PLUS FORMOTEROL FUMARATE 100/6 µg and 200/6 µg) ADMINISTERED WITH AND WITHOUT ACTIVATED CHARCOAL IN ADULT ASTHMATIC PATIENTS.

• IRAS ID

  110160

• Contact name

  Dave Singh

• Sponsor organisation

  CHIESI FARMACEUTICI S.p.A

• Eudract number

  2012-002370-30

• Research summary

  A total of 30 adult asthmatic patients will be randomised to receive CHF 1535 NEXThaler DPI 100/6 æg or 200/6 æg with or without activated charcoal, placebo ofluicasone 1000 æg according to an open-label, 6-way cross-over, single-dose design. 7 to 14 day wash-out period will separate six single dose treatment visits at clinic. Blood samples will be collected to evaluate pharmacokinetic parameters and also pharmacodynamic parameters, when applicable. Evaluation of general safety and tolerability of the study drug will be performed. Medical and laboratory examinations will take place within 14 days before the randomisation visit.

• REC name

  North West - Greater Manchester South Research Ethics Committee

• REC reference

  12/NW/0613

• Date of REC Opinion

  2 Oct 2012

• REC opinion

  Further Information Favourable Opinion