A study to evaluate CHF1535 NEXThaler in adult asthmatics

• Research type

  Research Study

• Full title

  A phase II, multicentre, double blind, randomised, 5-way cross-over study to test the non-inferiority of the acute bronchodilator effect of CHF 1535 200/6 µg NEXThaler® versus CHF 1535 100/6 µg NEXThaler® in partially controlled and uncontrolled adult asthmatic patients

• IRAS ID

  148508

• Contact name

  S Dave Singh

• Contact email

  dsingh@meu.org.uk

• Sponsor organisation

  CHIESI FARMACEUTICI S.p.A.

• Eudract number

  2013-004826-27

• Research summary

  To evaluate the effect of two strengths of CHF1535 (beclometasone an anti inflammatory corticosteroid ’preventer’ of asthma combined with formoterol a beta2-agonist ‘reliever’ of asthma)at 100/6 mcg per actuation and 200/6 mcg per actuation in partially controlled or uncontrolled adult asthmatics. Each participant will take 2 dose levels (1 and 4 puffs) of each strength of CHF 1535.

  The effect of the investigational drug will be evaluated by means of lung function test (i.e. breathing tests).

• REC name

  North West - Greater Manchester Central Research Ethics Committee

• REC reference

  14/NW/0070

• Date of REC Opinion

  18 Mar 2014

• REC opinion

  Further Information Favourable Opinion