drugset / Trial / NCT01720069

Clinical Study to Evaluate the Efficacy and Safety of VR506 Using a New Inhaler for the Treatment of Asthma

NCT01720069 ↗

Phase 2/3 Completed 197 enrolled Vectura Limited
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2012-10
Primary completion
2013-10
Completion
2013-10

Drugs

EvaluationDrugModalityDoseRoute
Comparator VR506 Unknown — Inhaled

Indications