The Pharmacodynamic effects of CHF1535 NEXThaler DPI on COPD

• Research type

  Research Study

• Full title

  A phase II, partial-blind, randomized, placebo controlled, 5-way cross-over clinical pharmacology study to evaluate the pharmacodynamics of BDP/B17MP and Formoterol across two different dose levels of CHF 1535 NEXThaler® DPI and CHF 1535 pMDI (both fixed combination of Beclomethasone dipropionate plus formoterol fumerate) in adult COPD patients.

• IRAS ID

  136809

• Contact name

  Dave Singh

• Contact email

  dsingh@meu.org.uk

• Sponsor organisation

  CHIESI FARMACEUTICI S.p.A

• Eudract number

  2013-002966-38

• Research summary

  A total of up to 50 adult COPD patients will be randomised to receive CHF 1535 100/6 NEXThaler at two different dose levels and CHF 1535 100/6 pMDI at two different dose according to a 5-way cross-over, placebo-controlled, single-dose design. A minimum 7 day wash-out period will separate five single dose treatment visits at the clinic. Blood samples will be collected to evaluate pharmacodynamic parameters. Vital signs and general safety and tolerability evaluation of the study drug will be performed. Medical and laboratory examinations will take place on the day of screening visit. Any eventual examination to be repeated may take place within the run-in period and before the randomisation visit.

• REC name

  North West - Greater Manchester Central Research Ethics Committee

• REC reference

  13/NW/0673

• Date of REC Opinion

  20 Nov 2013

• REC opinion

  Further Information Favourable Opinion