Conditions: Asthma
Keywords: Uncontrolled Asthma, Exacerbation, Safety
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 1147
Healthy volunteers: no

Brief summary:
The purpose is to Evaluate the Efficacy, Safety, and Tolerability of 3 Different Doses of AZD5069 Twice Daily as Add-on Treatment to Medium to High Dose Inhaled Corticosteroids (ICS) and Long-acting β2 Agonists (LABA), in Patients with Uncontrolled Persistent Asthma

Detailed description:
A 6-month, Randomised, Double-blind, Placebo-controlled, Multi-centre, Parallel-group, Phase II Study with an Optional Safety Extension Treatment Period up to 6 months, to Evaluate the Efficacy, Safety, and Tolerability of 3 Different Doses of AZD5069 Twice Daily as Add-on Treatment to Medium to High Dose Inhaled Corticosteroids (ICS) and Long-acting β2 Agonists (LABA), in Patients with Uncontrolled Persistent Asthma

Arms:
arm 1: AZD5069 oral capsules self-administered twice daily arm 2: AZD5069 oral capsules self-administered twice daily arm 3: AZD5069 oral capsules self-administered twice daily arm 4: Placebo oral capsules self-administered twice daily

Interventions: intervention 1: AZD5069 intervention 2: Placebo
Intervention descriptions: intervention 1: AZD5069 oral capsules self-administered twice daily. intervention 2: Placebo oral capsules self-administered twice daily.

Protocol document: