Clinical Study to Evaluate the Efficacy and Safety of VR506 Using a New Inhaler for the Treatment of Asthma
- Registration Number
- NCT01720069
- Lead Sponsor
- Vectura Limited
- 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
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 197
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Dose 3 VR506 VR506 VR506 inhalation powder delivered via a new dry powder inhaler device Dose 1 VR506 VR506 VR506 inhalation powder delivered via a new dry powder inhaler device Dose 2 VR506 VR506 VR506 inhalation powder delivered via a new dry powder inhaler device
- Primary Outcome Measures
Name Time Method Mean Prednisone/Prednisolone Dose for Analysis (PDA) at End of Study (Week 16) 16 weeks The mean asthma control prednisone/prednisolone dose at end of study (week 16)
- Secondary Outcome Measures
Name Time Method Number of Participants With Withdrawals Due to Worsening of Asthma 16 weeks Mean Change From Start of Treatment Baseline to End of Study (Week 16) for Asthma Control Questionnaire (ACQ-5) Mean Total Score Baseline and 16 weeks Change from baseline to end of study (week 16) in 5 item asthma control questionnaire (ACQ-5) mean total score (range 0 (better) to 6 (worse)). The mean total score is calculated as the mean for each subject at each visit of 5 questions, each scored from 0 (better) to 6 (worse).
Mean Change From Start of Treatment Baseline to End of Study (Week 16) for In-clinic Morning Pre-Dose Forced Expiratory Volume In 1 Second (FEV1) Baseline and 16 weeks Mean Change From Start of Treatment Baseline to End of Study (Week 16) for In-clinic Weekly Morning Pre-dose Peak Expiratory Flow (PEF) Baseline and 16 weeks Mean Change From Start of Treatment Baseline to End of Study (Week 16) for Weekly Average Asthma Night-time Symptom Score Baseline and 16 weeks To measure the change from baseline to end of study for the weekly mean asthma night time symptom score, scored from 0 (not at all bothered) to 6 (severely bothered).
Assessment of Acceptability of the Device 16 weeks Percentage of subjects that overall found it very easy or fairly easy to use the inhaler, based on inhaler acceptability questionnaire
Trial Locations
- Locations (77)
Vectura Clinical Trial Site 03008
🇩🇪Donaustauf, Germany
Vectura Clinicl Trial Site 07011
🇷🇴Timis, Romania
Vectura Clinical Trial Site 06011
🇺🇦Vinnitsa, Ukraine
Vectura Clinical Trial Site 08006
🇧🇬Ruse, Bulgaria
Vectura Clinical Trial Site 08005
🇧🇬Sofia, Bulgaria
Vectura Clinical Trial Site 05003
🇵🇱Warszawa, Poland
Vectura Clinical Trial Site 01006
🇺🇸Celebration, Florida, United States
Vectura Clinical Trial Site 01011
🇺🇸Saint Louis, Missouri, United States
Vectura Clinical Trial Site 01013
🇺🇸Jersey City, New Jersey, United States
Vectura Clinical Trial Site 01007
🇺🇸El Paso, Texas, United States
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 03003
🇩🇪Dortmund, Germany
Vectura Clinical Trial Site 03001
🇩🇪Hamburg, Germany
Vectura Clinical Trial Site 03007
🇩🇪Geesthacht, Germany
Vectura Clinical Trial Site 03002
🇩🇪Rudersdorf, Germany
Vectura Clinical Trial Site 04001
ðŸ‡ðŸ‡ºBudapest, Hungary
Vectura Clinical Trial Site 03005
🇩🇪Heidelberg, Germany
Vectura Clinical Trial Site 04004
ðŸ‡ðŸ‡ºBudapest, Hungary
Vectura Clinical Trial Site 04003
ðŸ‡ðŸ‡ºDebrecen, Hungary
Vectura Clinical Trial Site 04002
ðŸ‡ðŸ‡ºRakoczi, Hungary
Vectura Clinical Trial Site 04005
ðŸ‡ðŸ‡ºRakoczi, Hungary
Vectura Clinical Trial Site 05007
🇵🇱Tarnow, Poland
Vectura Clinical Trial Site 05002
🇵🇱Bialystok, Poland
Vectura Clinical Trial Site 05001
🇵🇱Lodz, Poland
Vectura Clinical Trial Site 05008
🇵🇱Bialystok, Poland
Vectura Clinical Trial Site 05010
🇵🇱Bialystok, Poland
Vectura Clinical Trial Site 05011
🇵🇱Krakow, Poland
Vectura Clinical Trial Site 05006
🇵🇱Lodz, Poland
Vectura Clinical Trial Site 05005
🇵🇱Lublin, Poland
Vectura Clinical Trial Site 05004
🇵🇱Zawadzkie, Poland
Vectura Clinical Trial Site 05009
🇵🇱Wroclaw, Poland
Vectura Clinical Trial Site 07005
🇷🇴Bucuresti, Romania
Vectura Clinical Trial Site 07001
🇷🇴Brasov, Romania
Vectura Clinical Trial Site 07008
🇷🇴Bucuresti, Romania
Vectura Clinical Trial Site 07013
🇷🇴Bucuresti, Romania
Vectura Clinical Trial Site 07003
🇷🇴Bucuresti, Romania
Vectura Clinical Trial Site 07007
🇷🇴Cluj-Napoca, Romania
Vectura Clinical Trial Site 07009
🇷🇴Cluj-Napoca, Romania
Vectura Clinical Trial Site 07010
🇷🇴Cod, Romania
Vectura Clinical Trial Site 07006
🇷🇴Cluj-Napoca, Romania
Vectura Clinical Trial Site 07014
🇷🇴Craiova, Romania
Vectura Clinical Trial Site 07002
🇷🇴Iasi, Romania
Vectura Clinical Trial Site 07004
🇷🇴Marghita, Romania
Vectura Clinical Trial Site 07012
🇷🇴Targu Mures, Romania
Vectura Clinical Trial Site 06013
🇺🇦AR Crimea, Ukraine
Vectura Clinical Trial Site 06009
🇺🇦Donetsk, Ukraine
Vectura Clinical Trial Site 06012
🇺🇦Ivano-Frankivsk, Ukraine
Vectura Clinical Trial Site 06010
🇺🇦Kharkiv, Ukraine
Vectura Clinical Trial Site 06001
🇺🇦Kharkiv, Ukraine
Vectura Clinical Trial Site 06004
🇺🇦Kharkiv, Ukraine
Vectura Clinical Trial Site 06006
🇺🇦Kyiv, Ukraine
Vectura Clinical Trial Site 06002
🇺🇦Kyiv, Ukraine
Vectura Clinical Trial Site 06003
🇺🇦Kyviv, Ukraine
Vectura Clinical Trial Site 06007
🇺🇦Zaporizhzhia, Ukraine
Vectura Clinical Trial Site 06015
🇺🇦Kyiv, Ukraine
Vectura Clinical Trial Site 06008
🇺🇦Mykolaiv, Ukraine
Vectura Clinical Trial Site 02003
🇬🇧Cottingham, Hull, United Kingdom
Vectura Clinical Trial site 02002
🇬🇧Birmingham, United Kingdom
Vectura Clinical Trial Site 06014
🇺🇦Zaporizhzhya, Ukraine
Vectura Clinical Trial Site 02004
🇬🇧Manchester, United Kingdom
Vectura Clinical Trial Site 02001
🇬🇧Newcastle, United Kingdom
Vectura Clinical Trial Site 02005
🇬🇧Nottingham, United Kingdom
Vectura Clinical Trial Site 01001
🇺🇸Los Angeles, California, United States
Vectura Clinial Trial Site 01005
🇺🇸Denver, Colorado, 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 01004
🇺🇸Bronx, New York, United States