NCT01720069

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

A Randomised Double-blind, Parallel Group, Dose-ranging Study to Evaluate the Efficacy and Safety of VR506 From a New Dry Powder Inhaler in Subjects With Severe Persistent Asthma Requiring Oral Corticosteroid Therapy.

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 197 (actual)
• Sponsor: Vectura Limited · Industry
• Sex: All
• Age: 12 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Asthma

Interventions

Type	Name	Description
DRUG	VR506	VR506 inhalation powder delivered via a new dry powder inhaler device

Timeline

• Start date: 2012-10-01
• Primary completion: 2013-10-01
• Completion: 2013-10-01
• First posted: 2012-11-01
• Last updated: 2020-04-21
• Results posted: 2020-04-21

Locations

77 sites across 8 countries: United States, Bulgaria, Germany, Hungary, Poland, Romania, Ukraine, United Kingdom