At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 197 enrolled
Drug / intervention
VR506drug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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.
In Brief
A Phase 3 clinical trial evaluating VR506 for Asthma. Completed, enrolled 197 participants across 77 sites in 8 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAsthma
CountriesBulgaria, Germany, Hungary, Poland, Romania, Ukraine, United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
Enrollment StartOct 2012
First PostedNov 2012
Primary CompletionOct 2013
TodayJul 2026
First PostedNov 1, 2012
Enrollment StartOct 1, 2012
Primary CompletionOct 1, 2013
TodayJul 2, 2026
Enrollment to primary: 1 yearPosted 13.7 years ago
Interventions
VR506drug
VR506 inhalation powder delivered via a new dry powder inhaler device