FOSTER High Strength vs QVAR in Asthmatic Patients

• Research type

  Research Study

• Full title

  A 12-WEEK, MULTICENTRE, MULTINATIONAL, RANDOMISED, DOUBLE-BLIND, DOUBLE-DUMMY, 2-ARM PARALLEL GROUP STUDY COMPARING THE EFFICACY AND SAFETY OF CHF 1535 200/6µg (FIXED COMBINATION BECLOMETHASONE DIPROPIONATE / FORMOTEROL) VERSUS BECLOMETHASONE DIPROPIONATE IN ADULTS ASTHMATIC PATIENTS NOT ADEQUATELY CONTROLLED ON HIGH DOSES OF INHALED CORTICOSTEROIDS OR ON MEDIUM DOSE OF INHALED CORTICOSTEROIDS PLUS LONG-ACTING ß2 AGONISTS

• IRAS ID

  97071

• Contact name

  John Robinson

• Sponsor organisation

  Chiesi Farmaceutici S.p.A.

• Eudract number

  2010-020602-14

• Research summary

  Foster© is an inhaled treatment for asthma already licensed for use by doctors in the UK. It is a combination of two kinds of medicine ?? a corticosteroid and a ??long acting beta agonist?? (or LABA). The corticosteroid ingredient (beclomethasone dipropionate) acts by decreasing inflammation of the airways, while the LABA ingredient (formoterol fumarate) works by opening up the breathing passages. At present only one strength of is Foster available to doctors in the UK. This study will test a new formulation of Foster© with double the strength of the corticosteroid ingredient (the strength of the LABA ingredient is the same). In this study, the new strength of Foster© will be tested against an existing asthma medicine (Qvar©) which just contains the same corticosteroid ingredient. The study will involve 12 weeks of treatment with either medicine in subjects whose asthma was not adequately controlled prior to the study despite them using high doses of inhaled corticosteroids (ICS) or medium dose of ICS long acting beta agonist (LABA). During this 12 week period breathing tests will be conducted to measure any differences in efficacy between the two medicines.

• REC name

  London - London Bridge Research Ethics Committee

• REC reference

  12/LO/0154

• Date of REC Opinion

  23 Mar 2012

• REC opinion

  Further Information Favourable Opinion