A research study to evaluate the effect of a new fixed triple combination of beclometasone dipropionate + formoterol fumarate + glycopyrronium bromide at high dose in patients with uncontrolled asthma

Update Il y a 4 ans
Reference: EUCTR2015-000717-40

Woman and Man

  • | Country :
  • -
  • | organs :
  • -
  • | Specialty :
  • -

Extract

- To demonstrate the superiority of CHF 5993 200/6/12.5 pMDI compared to CHF 1535 200/6 pMDI in terms of change from baseline in pre-dose FEV1 at Week 26. - To demonstrate the reduction of moderate and severe asthma exacerbations rate with CHF 5993 200/6/12.5 pMDI compared to CHF 1535 200/6 pMDI during the entire 52-week treatment period.


Inclusion criteria

  • uncontrolled asthma