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AZD1419 in eosinophilic moderate to severe asthma
NCT02898662Phase 2
Key facts
- Status
- Completed
- Start
- Oct 2016
- Primary completion
- Sep 2018
- Countries
- 4
- Sponsor
- AstraZeneca
- Modality
- Antisense DNA, Small Interfering RNA (siRNA), MicroRNA (miRNA)
- Drugs
- azd1419
- Conditions
- asthma
01
Overview
Phase 2, randomised, double-blind trial of azd1419 in asthma, sponsored by AstraZeneca. Started Oct 2016; status: completed.
02
Design
- Study design
- RandomizedDouble-blind
03
Who it enrols
Adults with eosinophilic moderate to severe asthma on ICS/LABA with FEV1 >= 50% and specific eosinophil counts.
04
Results
Not all primary endpoints met
05
Registry description
Ph2a study planned to be run at 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 severe asthma. The patients will receive 13 once weekly inhaled doses of the study drug. Treatment is initiated on top of their ICS/LABA controller medication, which is then tapered down and withdrawn during a period of 3 weeks and during the last 3 weeks of treatment the study drug is given as monotherapy. SABA is used as reliever medication during the whole study period. Primary…
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