Effect of CHF5188 on lung function in asthma patients (version 1.0)

• Research type

  Research Study

• Full title

  A randomised, double-blind, active-controlled, 3 way cross-over study to evaluate the effect on trough FEV1 after 4 weeks treatment with CHF 5188 pMDI QD (fixed combination Budesonide/Carmoterol) in adult patients with moderate or severe persistent asthma

• IRAS ID

  33724

• Contact name

  Dave Singh

• Sponsor organisation

  Chiesi Farmaceutici S.p.A.

• Eudract number

  2009-013759-32

• Research summary

  The main aim of this study is to investigate whether or not a new inhaled therapy (CHF5188) used once-a-day in the morning is superior to an existing therapy (budesonide extrafine pMDI) as assessed by tests of lung function after 4 weeks of treatment. This study will enroll patients with persistent asthma who are not optimally controlled with their existing inhaler therapy.The study also seeks to compare the efficacy of CHF5188 used once-a-day to another existing therapy (Seretide© Evohaler pMDI) which is administered twice-a-day. This comparison will take place after 4 weeks of treatment.Furthermore the study seeks to assess the occurrence of tolerance by comparing the effect of each treatment on lung function tests after the first and the last dose of study drug.

• REC name

  North West - Greater Manchester Central Research Ethics Committee

• REC reference

  09/H1008/135

• Date of REC Opinion

  3 Dec 2009

• REC opinion

  Further Information Favourable Opinion