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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
197
VR506 inhalation powder delivered via a new dry powder inhaler device
Mean Prednisone/Prednisolone Dose for Analysis (PDA) at End of Study (Week 16)
The mean asthma control prednisone/prednisolone dose at end of study (week 16)
Time frame: 16 weeks
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)
Time frame: Baseline and 16 weeks
Mean Change From Start of Treatment Baseline to End of Study (Week 16) for Asthma Control Questionnaire (ACQ-5) Mean Total Score
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).
Time frame: 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)
Time frame: 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
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).
Time frame: Baseline and 16 weeks
Number of Participants With Withdrawals Due to Worsening of Asthma
Time frame: 16 weeks
Assessment of Acceptability of the Device
Percentage of subjects that overall found it very easy or fairly easy to use the inhaler, based on inhaler acceptability questionnaire
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Vectura Clinical Trial Site 01001
Los Angeles, California, United States
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
...and 67 more locations
Time frame: 16 weeks