Conditions: Asthma
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 197
Healthy volunteers: no

Brief summary:
To evaluate the clinical efficacy, safety, tolerability and dose-response relationship, using oral corticosteroid (OCS) modulation, of 3 different doses of VR506 using a twice daily regimen from a new dry powder inhaler (nDPI) for 16 weeks in subjects with severe persistent asthma requiring OCS therapy, i.e. Step 5 treatment as defined by modified Global Initiative for Asthma (GINA) guidelines 2011.

Detailed description:

Arms:
arm 1: VR506 inhalation powder delivered via a new dry powder inhaler device arm 2: VR506 inhalation powder delivered via a new dry powder inhaler device arm 3: VR506 inhalation powder delivered via a new dry powder inhaler device

Interventions: intervention 1: VR506
Intervention descriptions: intervention 1: VR506 inhalation powder delivered via a new dry powder inhaler device

Protocol document: