TRISKEL

• Research type

  Research Study

• Full title

  A multicentre, randomised, double-blind, active-controlled, 3-way cross-over study to evaluate the efficacy and safety of a free combination of 3 doses of CHF 5259 (glycopyrrolate) plus Foster® 100/6µg (fixed combination of beclomethasone dipropionate plus formoterol) in a metered dose inhaler for the treatment of patients with uncontrolled asthma under medium doses of inhaled corticosteroids plus long-acting ß2-agonists

• IRAS ID

  147612

• Contact name

  S D Singh

• Contact email

  dsingh@meu.org.uk

• Sponsor organisation

  Chiesi Farmaceutici S.p.A.

• Eudract number

  2013-003043-36

• Research summary

  The purpose of the present study is to determine the optimal dose of CHF 5259 (Glycopyrrolate Bromide) to be taken together with Foster® 100/6 (Beclomethasone diproprionate/Formoterol fumarate 100/6 μg) in order to provide the best bronchodilator effect in patients whose asthma symptoms are uncontrolled by medium doses of inhaled corticosteroids plus long acting ß2-agonists.

  The four possible treatments in this study are three doses of Glycopyrrolate Bromide plus Foster® 100/6 (daily dose 400/24μg)and Foster® 100/6 (daily dose 400/24μg)alone.

  The study is a cross-over design where each subject will receive three out of the four possible treatments each for a 6 week treatment period, with each period separated by a one week washout period. Subjects will be in the study for 24 weeks.

• REC name

  North West - Greater Manchester Central Research Ethics Committee

• REC reference

  14/NW/0084

• Date of REC Opinion

  7 Apr 2014

• REC opinion

  Further Information Favourable Opinion