(1). Detailed Description:
study planned to be run in approximately 16-18 sites in 4 EU countries
(Denmark, Hungary, Poland and Sweden) enrolling approximately 170
patients to ensure 70 randomized patients with eosinophilic, moderate to
The study has a
withdrawal design.The patients will receive 13 once weekly inhaled doses
of the study drug (AZD1419 or placebo). Treatment is initiated with 6
doses of the study drug on top of their ICS/LABA controller medication.
Prior to the 7th dose of the study drug the LABA is withdrawn. The
following 3 doses are given when ICS is tapered down. Dose 7 is given on
top of 100% of their ICS, dose 8 is given on top of 50% of the ICS
dose, which is then tapered down to 25% the following week and withdrawn
completely prior to dose 10 of the study drug. During the last 3 weeks
of treatment (ie last 4 doses), the study drug is given as monotherapy.
SABA is used as reliever medication during the whole study period.
Primary endpoint is Loss of asthma control, defined as any of the
following criteria: a) An increase of ACQ-5 to 1.5 or more b) A
reduction of 30% or more in morning peak expiratory flow (PEF) from
baseline on 2 consecutive days c) At least six additional reliever
inhalations of SABA in a 24-hour period relative to baseline on 2
consecutive days and d) An exacerbation requiring systemic
When the endpoint is
met, patients will resume their regular ICS/LABA controller medication
and will be followed for an additional 4 weeks, when they do an Early
Discontinuation (ED) Visit and will thereafter leave the study. For
patients not loosing their asthma control, the full Observational period
is up to week 52, when they will do an End of Treatment Visit (EOT).
Study procedures are the same on ED and EOT Visits.