Clinical Study to Evaluate the Efficacy and Safety of VR506 Using a New Inhaler for the Treatment of Asthma
Completed · Phase 2/Phase 3
Conditions studied: Asthma
In brief
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.
Key facts
- Study ID
- NCT01720069
- Run by
- Vectura Limited
- People needed
- 197
- Starts
- 2012-10-01
- Expected to finish
- 2013-10-01
- Last updated by the study team
- 2020-04-21
Who can join
Age: 12 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Vectura Clinial Trial Site 01005 — Denver, Colorado, United States
- Vectura Clinical Trial Site 01006 — Celebration, Florida, United States
- Vectura Clinical Trial Site 01015 — Hialeah, Florida, United States
- Vectura Clinical Trial Site 01012 — Miami Lakes, Florida, United States
- Vectura Clinical Trial Site 01014 — Orlando, Florida, United States
- Vectura Clinical Trial Site 01003 — Tampa, Florida, United States
- Vectura Clinical Trial Site 01011 — St Louis, Missouri, United States
- Vectura Clinical Trial Site 01013 — Jersey City, New Jersey, United States
- Vectura Clinical Trial Site 01004 — The Bronx, New York, United States
- Vectura Clinical Trial Site 01007 — El Paso, Texas, United States
- Vectura Clinical Trial Site 08006 — Rousse, Bulgaria
- Vectura Clinical Trial Site 08005 — Sofia, Bulgaria
- Vectura Clinical Trial Site 08001 — Sofia, Bulgaria
- Vectura Clinical Trial Site 08003 — Sofia, Bulgaria
- Vectura Clinical Trial Site 08007 — Sofia, Bulgaria
- Vectura Clinical Trial Site 08004 — Sofia, Bulgaria
- Vectura Clinical Trial Site 08002 — Stara Zagora, Bulgaria
- Vectura Clinical Trial Site 08008 — Varna, Bulgaria
- Vectura Clinical Trial Site 03006 — Berlin, Germany
- Vectura Clinical Trial Site 03009 — Berlin, Germany
- Vectura Clinical Trial Site 03004 — Bonn, Germany
- Vectura Clinical Trial Site 03008 — Donaustauf, Germany
- Vectura Clinical Trial Site 03003 — Dortmund, Germany
- Vectura Clinical Trial Site 03007 — Geesthacht, Germany
- Vectura Clinical Trial Site 01001 — Los Angeles, California, United States
Full record on ClinicalTrials.gov
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